strengthen the evidence base for maternal and …...pregnancy have high levels of nicotine exposure,...

Smoking in Pregnancy Evidence Review14.1

Lan T. Le, MPARachel Brady, PT, DPT, MSBeth DeFrancis Sun, MLS

Deborah F. Perry, PhDJohn Richards, MA, AITP

National Center for Education in Maternal and Child Health

Georgetown University

FEBRUARY 2020

Strengthen the Evidence Base for Maternal and Child Health Programs

Suggested Citation: Le, LT, Brady, RA, DeFrancis Sun, B, Perry, DF, Richards, J. National Performance Measure 14.1 Smoking in Pregnancy Evidence Review. Strengthen the Evidence Base for Maternal and Child Health Programs. National Center for Education in Maternal and Child Health, Georgetown University, Washington DC. 2020.

This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number U02MC31613, MCH Advanced Education Policy, $3.5 M. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.

REPORTEXECUTIVE SUMMARY ............................................................................................................................................. 5ACKNOWLEDGMENTS ......................................................................................................................................... 15INTRODUCTION ...................................................................................................................................................... 16BACKGROUND ....................................................................................................................................................... 17 National Performance Measure ........................................................................................................................17 Evidence-based or informed Strategy Measure ...............................................................................................19 National Survey Data ........................................................................................................................................ 21 Overview ............................................................................................................................................................ 22 Systematic Reviews ............................................................................................................................................ 34METHODS................................................................................................................................................................. 36Databases and Search Terms ................................................................................................................................... 36Inclusion and Exclusion Criteria ................................................................................................................................ 37Screening Process...................................................................................................................................................... 38Evidence Continuum .................................................................................................................................................. 40RESULTS ..................................................................................................................................................................... 41 Characteristics of Studies Reviewed ................................................................................................................. 41 Intervention Types and Components ................................................................................................................. 42 Data Sources and Outcomes ............................................................................................................................ 44 Limitations ............................................................................................................................................................ 45 Evidence Rating and Evidence Continuum ....................................................................................................... 45 Key Findings ....................................................................................................................................................... 47DISCUSSION AND IMPLICATIONS ...................................................................................................................... 49 Data Trends ......................................................................................................................................................... 49 Highlights of Effective Intervention Studies ........................................................................................................ 50 Implications for Practice ..................................................................................................................................... 52 Policy and Population-level Interventions ........................................................................................................... 58 The Importance of Partnership and the Role of Title V ..................................................................................... 59FROM EVIDENCE TO ACTION ............................................................................................................................. 60

FIGURES AND TABLESFigure 1. Flow Chart of the Review Process and Results ........................................................................................ 63Figure 2. Evidence Continuum ................................................................................................................................. 64Table 1: Detailed Search Strategies......................................................................................................................... 65Table 2: Evidence Rating Criteria ............................................................................................................................ 67Table 3: Study Characteristics .................................................................................................................................. 68Table 4: Intervention Descriptions ............................................................................................................................. 73Table 5: Data Sources and Outcomes ..................................................................................................................... 84Table 6: Limitations .................................................................................................................................................... 94Table 7: Individual Evidence Ratings ....................................................................................................................... 97

REFERENCES ..................................................................................................................................................... 99

TABLE OF CONTENTS

EXECUTIVE SUMMARY

NPM 14.1: SMOKING IN PREGNANCY EVIDENCE REVIEWNational Center for Education in Maternal and Child Health | Georgetown University

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EXECUTIVE SUMMARYSmoking is one of fifteen Maternal and Child Health (MCH) National Performance Measures (NPMs) for the State Title V MCH Services Block Grant to States program (hereafter referred to as the MCH Block Grant).1 The goal of NPM 14.1: Smoking–Pregnancy is to decrease the percent of women who smoke during pregnancy. The purpose of this evidence analysis review is to identify evidence-based and evidence-informed strategies that MCH Block Grant programs can implement to support smoking cessation in pregnancy. Interventions that impact smoking during pregnancy range from psychosocial interventions, such as counseling, incentives, and feedback, to pharmacotherapy, such as nicotine replacement therapy (NRT), as well as policy-related interventions, such as smoke-free legislation, tobacco taxation, and media campaigns. There are separate and extensive bodies of literature associated with each of these approaches. This evidence analysis review focuses primarily on the most recent literature on individual-level and population-based interventions to decrease smoking during pregnancy.

Background. Smoking is one of the most important modifiable causes of poor pregnancy outcomes in the United States (U.S.) and is associated with maternal, fetal, and infant morbidity and mortality (American College of Obstetricians and Gynecologists (ACOG), 2017). According to the Centers for Disease Control and Prevention (CDC), smoking reduces a woman’s chances of getting pregnant, increases the risk for pregnancy complications, and harms babies before and after they are born.2 The U.S. Surgeon General reports that women who smoke, like men, are at increased risk of cancer, cardiovascular disease, pulmonary disease, and premature death, but they also experience unique risks related to menstrual and reproductive function (Office on Smoking and Health, 2001). Smoking harms many aspects and every phase of reproduction (USDHHS, 2004).

Smoking during pregnancy increases the risk of health problems for both mothers and babies, such as pregnancy complications, premature birth, low birth weight, stillbirth, infant death, and birth defects of the mouth and lip, as well as possible cognitive effects associated with learning disabilities and conduct disorders (DiFranza & Lew, 1995; Drews et al., 1996; Fiore et al., 2008; Makin, 1991; USDHHS, 2004; Wakschlag, 1997). An estimated 5-8% of preterm deliveries,

1 https://mchb.tvisdata.hrsa.gov/uploadedfiles/Documents/blockgrantguidance.pdf2 https://www.cdc.gov/tobacco/basic_information/health_effects/pregnancy/index.htm

REPORT


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EXECUTIVE SUMMARY

13-19% of term deliveries of infants with low birth weight, 23-34% of cases of sudden infant death syndrome (SIDS), and 5-7% of preterm-related deaths can be attributed to prenatal maternal smoking (Dietz et al., 2010). Women who quit smoking before or during pregnancy reduce the risk for adverse reproductive outcomes.

Health inequities and maternal smoking. While the majority of women understand that tobacco use damages health, for many smoking is a means of coping with poverty, disadvantage, and lack of control over other aspects of life (Graham, 1993). The key factors that contribute to smoking in pregnancy are caring responsibilities, access to material resources, and having a partner who smokes (Dolan-Mullen, 2004). For some women, smoking may be a way to alleviate stress and if they are grappling with other addictive behaviors, then quitting smoking may not be the highest priority. Women who continue to smoke in pregnancy are more likely to have a low income, higher parity, no partner, low levels of social support, and limited education, and they are more likely to access publicly funded maternity care, and more likely to feel criticized by society (Ebert 2007; Frost 1994; Graham 1977; Graham 1996; Pickett 2009; Schneider 2008; Smedberg 2014; USDHHS 2004; Wakschlag 2003). There is a clear link between smoking in pregnancy and social disadvantage; the greater the disadvantage, the higher the smoking prevalence.3

In the U.S., increased public health education measures and public health campaigns have led to a decrease in smoking by pregnant and non-pregnant women of reproductive age (Colman & Joyce, 2003). Pregnancy itself is also a strong motivator. Women are more than likely to stop smoking during pregnancy, both spontaneously and with assistance, than at other times in their lives (Office on Smoking and Health, 2001). Forty-six percent of pre-pregnancy smokers quit smoking directly before or during pregnancy (Colman & Joyce, 2003). Although the rate of reported smoking during pregnancy has decreased overall, for some populations, such as adolescent females and non-Hispanic white and American Indian women with less education, the decrease was not as dramatic (Martin et al., 2009; Tong et al., 2009). Since a mother-to-be is generally highly motivated to do what she can to have a healthy baby, clinical providers can tap into that motivation, capitalizing on a “teachable moment” to help parents achieve long-term healthy lifestyle changes for themselves and their families (ACOG, 2011).

Clinical practice guidelines and clinical intervention strategies. National and state organizations have put forth clinical guidance and best practice guidelines to support smoking cessation during pregnancy and to diminish child exposure to secondhand smoke (SHS). In 2008, an update was published for the U.S. Public Health Service-sponsored Clinical Practice Guideline on tobacco use and dependence. The Guideline urged every clinician, health plan, and health care institution to make treating tobacco dependence a top priority during clinical visits and ask patients two key questions, “Do you smoke?” and “Do you want to quit?” followed by use of the recommendations in the Guideline. The Guideline recommends that health

3 https://www.publichealth.hscni.net/sites/default/files/Guide%203%20Reducing%20Smoking%20in%20Pregnancy.pdf

EXECUTIVE SUMMARY


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professionals follow a brief, evidence-based cessation intervention known as the “5 A’s: Ask about tobacco use, Advise tobacco users to quit, Assess willingness to make a quit attempt, Assist tobacco users in making a quit attempt, and Arrange for follow-up” (Fiore et al., 2008).

This approach was originally published by the National Cancer Institute (NCI) and has been reviewed and updated by governmental, academic, and private education groups (Glynn, 1990, Melvin et al., 2000, Fiore et al., 2008). The 5 A’s method for brief interventions has substantial research support for its utility in helping tobacco users across a variety of settings and can be incorporated with motivational strategies in a step-by-step process.4 Continuing the 5 A’s approach after a woman gives birth helps her continue her efforts to quit smoking or maintain smoking cessation (ACOG, 2011). For patients who relapse, clinicians should revisit the 5 A’s and keep reiterating the positive effects of quitting (ACOG, 2011). Although some professional organizations endorse a modified three-step process “Ask, advise, and refer,” this method has not been proven to be effective in pregnancy (ACOG, 2011).

National survey data. The National Vital Statistics System (NVSS) enables the Center for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS) to collect and disseminate the nation’s official vital statistics.5 The 2003 revision of the U.S. Standard Certificate of Live Birth included new and modified items on maternal cigarette smoking before and during pregnancy.6 The 2016 natality data file is the first for which this self-report7 information is available for all states and the District of Columbia (D.C.).8 Cigarette smoking during pregnancy was shown to differ across states, as well as by maternal age, race and Hispanic origin, and educational attainment.9 The 2016 data revealed that 7.2% of women who gave birth that year smoked cigarettes during pregnancy.10 This translates to 1 in 14 women smoking while pregnant.11 Maternal smoking during pregnancy was most common among women aged 20-24, non-Hispanic American Indian or Alaska Native mothers, and women with a high school education or less.12

Psychosocial interventions. Psychosocial interventions for pregnant women include counseling, health education, incentives, social support, structured support for physical activity, and feedback (Chamberlain et al., 2017).13 At the individual level, brief interventions are 5-10 minute focused conversations with a trained person; behavioral counseling can include individualized support from a cessation specialist; educational materials can include self-help resources; telephone counseling and quit lines are available for support; and group counseling programs are available.

4 https://mdquit.org/cessation-programs/brief-interventions-55 https://www.cdc.gov/nchs/nvss/index.htm6 https://www.cdc.gov/nchs/products/databriefs/db305.htm7 Given that these data are self-report and the stigma associated with smoking during pregnancy, there is the possibility that women underreported smoking while pregnant.8 https://www.cdc.gov/nchs/products/databriefs/db305.htm9 https://www.cdc.gov/nchs/data/databriefs/db305.pdf10 https://www.cdc.gov/nchs/products/databriefs/db305.htm11 https://www.cdc.gov/nchs/products/databriefs/db305.htm12 https://www.cdc.gov/nchs/data/databriefs/db305.pdf13 https://www.healthypeople.gov/2020/tools-resources/evidence-based-resource/psychosocial-interventions-for-supporting-women-to-stop


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EXECUTIVE SUMMARY

Incentives or rewards can include cash, vouchers, lottery tickets, prize draws, or other products or materials. Social support can involve peers, professionals, or partners (e.g., “quitpals”). Structured support for physical activity can include low impact exercise, such as treadmill walking. Feedback interventions give pregnant women information about the health of their fetuses and the levels of tobacco byproducts in their bodies (e.g., cotinine or carbon monoxide (CO) measurements) (Chamberlain et al., 2017).14

Pharmacological interventions. It is recommended that pregnant women try to quit smoking without using pharmacologic agents, such as nicotine replacement therapy (NRT), bupropion, and varenicline, if at all possible. These have not been sufficiently tested for efficacy and safety in pregnant patients and should not be used as first-line smoking cessation strategies (ACOG, 2011). The evidence is also inconclusive as to whether smoking cessation medications boost abstinence rates in pregnant smokers (ACOG, 2011). Additionally, U.S. clinical trials with sufficient power to determine statistical significance have been pulled or ended due to data or safety monitoring issues (Fiore et al., 2008; ACOG, 2011). The U.S. Preventive Services Task Force (USPSTF) has concluded that current evidence is insufficient to assess the balance of benefits and harms of nicotine replacement products and other pharmaceuticals for smoking cessation during pregnancy (Siu, 2015; ACOG, 2017).

Findings from systematic reviews. Chamberlain et al. (2017) concluded that psychosocial interventions can support women to quit smoking in pregnancy and should be considered for women who are pregnant or trying to become pregnant. There is also high-quality evidence that these interventions reduce the risks of infants being born with low birth weight and being admitted to neonatal intensive care units (NICUs) immediately after birth. Pregnant women in these studies expect and appreciate support to stop smoking, and interventions are more likely to improve women’s psychological well-being.

Coleman et al. (2015) stated that there is weak evidence to suggest that NRT with behavioral support for smoking cessation in pregnancy is effective. NRT is already used quite widely in some jurisdictions and accruing evidence is that this clinical practice does no harm. In actuality, there is no evidence that NRT has either a positive or negative impact on pregnancy and infant outcomes. Excluding non-placebo NRT trials from a pooled analysis reveals that improvement over placebo was not statistically significant. As such, the authors rated the evidence that NRT could be effective for smoking cessation during pregnancy as weak and recommended further research.

Evidence-informed studies/strategies to decrease the number of women who smoke during pregnancy. The evidence analysis review categorized interventions along an evidence continuum from evidence against (least favorable) to scientifically rigorous (most favorable). Each included study was rated on its own merit. Intervention types were also grouped together and rated as a category to speak to the public health impact.

14 https://www.healthypeople.gov/2020/tools-resources/evidence-based-resource/psychosocial-interventions-for-supporting-women-to-stop

EXECUTIVE SUMMARY


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The evidence ratings include:15

EVIDENCE RATING DEFINITION

Evidence Against Studies with this rating are not good investments. These strategies have been tested in many robust studies, are not effective, and sometimes produce harmful results.

Mixed EvidenceH

Strategies with this rating have been tested more than once and results are inconsistent or trend negative; further research is needed to confirm effects.

Emerging EvidenceH H

Strategies with this rating have limited research documenting effects. These strategies need further research, often with stronger designs, to confirm effects.

Expert OpinionH H H

Strategies with this rating are recommended by credible, impartial experts and are consistent with accepted theoretical frameworks. However, the strategies have limited research documenting effects; further research, often with stronger designs, is needed to confirm effects.

Moderate EvidenceH H H H

Strategies with this rating are likely to work, but further research is needed to confirm effects. These strategies have been tested more than once and results trend positive overall.

Scientifically RigorousH H H H H

Strategies with these ratings are most likely to make a difference. These strategies have been tested in many robust studies with consistently positive results.

The table below summarizes the evidence-based and evidence-informed strategies (n=42) to decrease the number of women who smoke during pregnancy by setting, intervention type, strategy, and overall evidence rating.16 The target audience for the interventions is pregnant women with one exception—the health care provider training is focused on health care practitioners.

Summary of Evidence-Based and Evidence-Informed Strategies to Decrease the Number of Women Who Smoke During Pregnancy

SETTING INTERVENTION TYPE

STRATEGY EVIDENCE RATING

Clinic-based Incentive Financial incentives and vouchers to enhance smoking abstinence in a multicomponent standard smoking cessation package for pregnant women (n=7) (Lopez, 2015a; Lopez, 2015b; Olson, 2019; Passey, 2018; Tappin, 2015; Wen, 2019; Zvorsky, 2015)

Moderate evidence

Counseling Enhanced adult smoking cessation program with motivational interviewing targeting pregnant women (n=6) (Bailey 2015; Fallin-Bennet, 2019; Lee, 2015; Naughton, 2017; Patten, 2019; Reynolds, 2019)

Moderate evidence

Multicomponent psychosocial

Multicomponent standard smoking cessation package for pregnant women embedded into Women, Infants, and Children (WIC) prenatal care clinic services (n=1) (Olaiya, 2015)

Moderate evidence

Pharmacotherapy NRT + multicomponent standard smoking cessation package for pregnant women (n=1) (Berlin 2014)

Moderate evidence

Health care provider training

Health care provider training including maternity staff, administrators and smoking cessation counselors; or midwives (n=2) (Bell 2018; Chertok, 2015)

Moderate/Emerging evidence

Automatic initiation of smoking cessation program

Biochemical verification or electronic health records used to automatically opt in pregnant smokers to smoking cessation program (n=3) (Bailey 2017; Buchanan, 2017; Campbell, 2017)

Emerging evidence

15 https://www.mchevidence.org/tools/16 The strategies are arranged by setting and the strength of the evidence ratings from most to least favorable.


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EXECUTIVE SUMMARY



Feedback Indoor air quality measurement feedback + multicomponent standard smoking cessation package for pregnant women (n=1) (Morgan, 2016)

Emerging evidence

Exercise Exercise + multicomponent standard smoking cessation package for pregnant women (n=3) (Jin, 2018; Ussher, 2015a; Ussher, 2015b)

Evidence against

Electronic Health education Standard motivational text messages added to support standard multicomponent smoking cessation program for pregnant women (n=1) (Forinash, 2018)

Moderate evidence

Health education + Incentives

Standard smoking cessation text messages specific to pregnant women + monetary incentives/gift vouchers to complete follow up at 1, 3 and 6 months (n=2) (Abroms 2017a; Abroms 2017b)


Health education + Social support

Standard smoking cessation text messages with limited interaction for support to pregnant women + social support for quitting via a “quitpal” (n=1) (Abroms 2015)

Emerging evidence

Counseling Telephone, internet platform or text application to deliver individual counseling support for smoking cessation (n=4) (Coleman-Cowger, 2018; Cummins, 2016; Sloan 2017; Stiegler, 2016)

Emerging evidence

Counseling + Incentives + Feedback

Web-based, incentive-based contingency management program + phone-delivered cessation counseling + feedback based on breath CO results (n=1) (Harris, 2015)

Emerging evidence

Journaling Online journaling platform to support smoking cessation for pregnant women (n=1) (Minian, 2016)

Emerging evidence

Community-based


Home visitors use smoking cessation strategies (education, motivational interviewing, referral to smoking cessation resources) during home visiting program visits (n=1) (Griffis, 2016)

Moderate evidence

Counseling Trained midwives to provide smoking cessation counseling with standard smoking cessation package to pregnant women and household members in home-based care (n=1) (Eddy, 2015)

Emerging evidence

Social support Using voluntary community members as community support workers to deliver in-person, culturally appropriate multicomponent smoking cessation package to pregnant women (n=1) (Glover, 2016)

Emerging evidence

Population-based

Policy National, state or local anti-smoking campaigns or regulations to increase smoke free environments (n=5) (Bartholomew 2016; Brown, 2016; England, 2017; Hankins, 2016; Havard, 2018)

Mixed evidence

Evidence continuum. The intervention strategies were visually plotted along the evidence continuum by setting below.

Counseling (n=6)

Incentives (n=7)

Multicomponent psychosocial (n=1)

Nicotine replacement therapy (n=1)

H e a l t h c a r e p r o v i d e r t r a i n i n g ( n = 2 )

Automatic initiation of

smoking cessation program (n=3)

Feedback (n=1)

Evidenced-Based

EVIDENCE AGAINST

EMERGING EVIDENCE

MIXED EVIDENCE

EXPERT OPINION

MODERATE EVIDENCE

SCIENTIFICALLY RIGOROUS

Evidenced-InformedEvidenced-informedor Evidenced-Based

Exercise (n=3)

CLIN

IC-B

ASE

D SE

TTIN

G

EXECUTIVE SUMMARY


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Key findings. Overall, 6 key findings emerged from the analysis:1. In terms of setting, of the 42 studies:

a. 24 studies (57%%) were clinic-based interventions (e.g., obstetrical/prenatal/primary care clinics, community health centers, hospital delivery units),

b. 3 studies (7%) were community-based interventions (e.g., home/residential health care, community-based home visiting organizations),

c. 10 (24%) of the studies were conducted electronically (e.g., phone applications, telephone, online), and

d. 5 (12%) were policy interventions to increase smoke-free environments.2. Psychosocial interventions tested are predominately focused on enhancing standard

multicomponent smoking cessation programs for pregnant women.a. The standard package generally consisted of the 5 A’s of smoking cessation (Ask, Advise,

Assess, Assist, and Arrange) or a variation of this approach under the guidance of trained practitioners to help women quit smoking or maintain smoking cessation during and after pregnancy.

Evidenced-Based

EVIDENCE AGAINST

EMERGING EVIDENCE

MIXED EVIDENCE

EXPERT OPINION

MODERATE EVIDENCE




Counseling (n=1)

Social support (n=1)

COM

MU

NIT

Y-BA

SED

SETT

ING

Counseling (n=4)

Counseling + Feedback +

Incentives (n=1)

Health edcuation + Social support

(n=1)

Journaling (n=1)

ELEC

TRO

NIC

SET

TIN

G

Health edcuation

(n=1)

H e a l t h e d u c a t i o n + I n c e n t i v e s ( n = 2 )

Policy (n=5)

POPU

LATI

ON

-BA

SED

SETT

ING


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EXECUTIVE SUMMARY

b. This clinic-based (or office-based) intervention that systematically identifies pregnant women who smoke and offers treatment or referral has been proven to increase quit rates.

c. Studies primarily used clinical settings to build in additional intervention components to support smoking cessation for pregnant women.

3. Psychosocial interventions that encourage behavior change and support smoking cessation consist of counseling, incentives, health education, exercise, feedback, and social support. Psychosocial interventions were delivered in clinic-based, electronic, and community-based settings.a. Counseling and incentives were the most frequently used and effective standalone

interventions. There is moderate evidence for both of these intervention types. Chamberlain et al. (2017) found that counseling, incentives, and feedback appeared to be effective in reducing the number of women who smoke late in pregnancy; the provision of health education and risk advice alone is not sufficient.

b. Different combinations of intervention components are used to enhance the effectiveness of smoking cessation for pregnant women. Intervention components were most often combined when programs were delivered electronically. There is primarily emerging evidence for the different configurations of intervention components (e.g., counseling + health education; counseling + feedback + incentives; health education + incentives; health education + social support). Given the limited number of studies on these combinations of components, further research is needed to determine effectiveness.

c. Embedding multicomponent psychosocial programs into community-based programs, such as home visiting, or social service programs, such as Women, Infants and Children (WIC), have moderate evidence of effectiveness to increase smoking cessation in the pregnant women they serve.

4. Researchers are attempting to use novel ways of delivering psychosocial interventions to increase the reach and effectiveness of smoking cessation programs in pregnancy, such as technology or culturally acceptable practices.a. Both general and individualized mobile phone applications have been attempted with

some positive trends.b. Individualized phone counseling is used to support behavior change and smoking cessation.c. Internet-based/website education, incentives, feedback, and support are being

increasingly utilized for smoking cessation during pregnancy.d. Community health workers or a culturally acceptable equivalent are being used to reach

indigenous or isolated communities of pregnant women with high smoking rates.5. Pharmacological interventions for smoking in pregnancy can include NRT, varenicline,

bupropion, and electronic nicotine delivery systems (ENDS). However, their efficacy and safety in pregnancy remains unknown.a. Pharmacotherapies were oftentimes included as part of tailored interventions where

pregnant women were offered higher levels of psychosocial support, referrals, and a menu of cessation aids.

EXECUTIVE SUMMARY


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b. There was 1 pharmacotherapy study included in this review on the use of NRT that was rated as moderate evidence. Results from Coleman et al. (2015) indicate that NRT used for smoking cessation increased rates measured in late pregnancy by approximately 40%. However, there is evidence suggesting that when potentially-biased, non-placebo trials are excluded from the analyses, NRT is no more effective than placebos.

6. Population-based interventions consist of non-clinical, public policy-related efforts, such as smoke-free legislation or smoking bans, tobacco taxation, product regulation, advertising/marketing restrictions, and media campaigns. For the 5 studies in this evidence review that focused on population-based messaging, campaigns, smoke-free policies, and access to health coverage, there was mixed evidence of effectiveness in specifically supporting pregnant women to become smoke-free.

Discussion and implications. Though it is estimated that 7.2% of women smoked cigarettes during pregnancy in 2016,17 the strong social norms discouraging smoking among pregnant women may lead some women to withhold disclosure of their true smoking status. Screening that considers the stigma associated with smoking in pregnancy and provides supportive guidance and resources is necessary. The 5 A’s method for brief interventions has substantial research support for its utility to help tobacco users, including pregnant women, quit smoking and maintain smoking cessation (ACOG, 2011). Accumulating evidence from systematic reviews and a review of the most recent literature reveals that psychosocial interventions, such as counseling and incentives, particularly as enhancements to a standard smoking cessation package, can be quite effective to help pregnant women quit smoking.

Short counseling sessions with pregnancy-specific health educational materials and referrals to a quit line have been demonstrated to be an effective smoking cessation strategy. In addition, evidence from recent studies conducted in the U.S., Australia, and the United Kingdom build on earlier findings that support both the efficacy and cost-effectiveness of contingency-based financial incentives as a smoking deterrent (Boyd et al., 2015). With concerns around the safety and efficacy of pharmacotherapies for pregnant women, the vast majority of interventions are psychosocial in nature. Other psychosocial interventions with a growing evidence base include health education, social support, feedback, and automatic initiation of a smoking cessation program. With multicomponent psychosocial interventions showing value, further research is needed to determine the effectiveness of different intervention configurations.

There was evidence against exercise interventions that provided structured support for physical activity. These interventions may have been ineffective due to the short duration and/or insufficient dosage. It seems that supplementing behavioral support with a physical activity is no more effective than behavioral support alone in promoting smoking cessation during pregnancy. Lastly, although population-based interventions, such as smoking bans and media campaigns, help promote a cultural norm toward smoke-free environments, the evidence is mixed with regard to increasing quit rates specifically for pregnant women. One study with moderate

17 https://www.cdc.gov/nchs/products/databriefs/db305.htm


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EXECUTIVE SUMMARY

evidence reported that exposure to a national anti-smoking campaign for a general audience was associated with smoking cessation in pregnant women; further research may be warranted to determine the effects of media campaigns and other policy interventions.

The importance of partnership and the role of Title V. Partnership is essential to effective implementation of smoking cessation interventions for pregnant women. Leaders in the field recognized the need to sustain the tremendous progress towards smoke-free pregnancies by creating a coordinated plan of action to close the remaining gaps in treatment and prevention of maternal smoking (Orleans et al., 2004). In 2002, the need for action led to the creation of the National Partnership to Help Pregnant Smokers Quit, a collaboration of more than 50 organizations and agencies, public and private, that joined forces to help pregnant smokers quit by providing effective clinical and community-based interventions to every smoker who is pregnant.18 This national partnership provided a model for how agencies and organizations can coalesce around a common cause—the prevention of maternal smoking—and promote a common agenda and set of strategies to more effectively help pregnant smokers quit. Today, cross-system collaboration remains pivotal to further reduce prenatal smoking. National experts, such as the CDC’s Office of Smoking and Health, ACOG, the U.S. Preventive Services Task Force, and the Robert Wood Johnson Foundation, are leading efforts to further reduce smoking during pregnancy. Title V programs are well positioned to coordinate and partner with these and other public and private agencies and organizations, especially state and territorial health agencies, state-funded quit lines, WIC, and state or local authorities responsible for the implementation and enforcement of tobacco control laws (e.g., state departments of health, county health departments, local health departments)19 to promote and provide widespread support for smoking cessation during pregnancy.

Notably, in 2013, the Association of State and Territorial Health Officials, with funding from the CDC, created an issue brief on smoking cessation strategies for women before, during, and after pregnancy.20 This resource can readily inform the work of Title V programs to engage in a coordinated health systems approach with partners to promote smoking cessation for pregnant women and mothers. These recommendations include: 1) Provide training and technical assistance to healthcare and public health providers on helping women quit using tobacco before, during, and after pregnancy; 2) Extend pregnancy-specific and postpartum-specific quit line services to women during and after pregnancy; 3) Promote awareness of cessation benefits and effectiveness of treatment by implementing coordinated media campaigns that specifically target women during childbearing years; 4) Develop customized programs for specific at-risk populations of women who are smokers and of reproductive age; 5) Include WIC sites as points for intervening with pregnant and postpartum women; 6) Design and promote barrier-free cessation coverage benefits for pregnant women in public and private health plans; 7) Promote cessation service integration aimed at improving birth outcomes; and 8) Implement evidence-based tobacco control policies that augment tobacco cessation for women before, during, and after pregnancy.21 18 http://tobacco-cessation.org/sf/pdfs/pub/11)%20National%20Partnership%20Action%20Plan.pdf19 https://www.rand.org/content/dam/rand/pubs/monograph_reports/2006/MR841.pdf20 https://www.astho.org/Prevention/Tobacco/Smoking-Cessation-Pregnancy/21 https://www.astho.org/Prevention/Tobacco/Smoking-Cessation-Pregnancy/

ACKNOWLEDGMENTS


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Tobacco-free pregnancies requires a multipronged approach supported at the community, state, and federal levels by a network of committed partners, including Title V programs.

From evidence to action. The final section of this document provides recommendations for intervention implementation strategies and recommendations for development of evidence-based or informed strategy measures (ESMs). This section also directs the reader to implementation resources, additional promising practices, and sample ESMs currently in use by Title V agencies with the goal of providing states a structured and practical approach to support integrating evidence into their work.

ACKNOWLEDGMENTSWe are thankful for the partnerships and collaborations that enabled us to complete this important evidence analysis review. In particular, we would like to thank:

Cynthia Minkovitz, MD, MPP, Donna Strobino, PhD, and their team at the Women’s and Children’s Health Policy Center at Johns Hopkins University (JHU) for their assistance during the transition of the initiative. For NPM 14.1: Smoking–Pregnancy, they shared the search terms. Their team originally adapted the evidence continuum and created the report structure in collaboration with federal partners for the evidence analysis reviews.

Our project officer, Jessica Minnaert, MPH, and the Director of Epidemiology and Research, Michael Kogan, PhD, from HRSA MCHB for their support and guidance throughout this process. We greatly appreciate the careful review and valuable suggestions made by Vanessa Lee, MPH, from the Division of Healthy Start and Perinatal Services at HRSA MCHB.

Our research expert, Cathy Melvin, PhD, MPH, Professor and Director, Division of Health Behavior and Health Promotion, Medical University of South Carolina, for providing thoughtful and helpful feedback.

Our colleague, Olivia Pickett, MA, MLS, for her expertise in constructing search strategies and running searches in several databases to provide the foundation for our review of the evidence. To Peter Hanssen, MA, for reviewing and summarizing background documents and organizing search results. To Keisha Watson, PhD, for her help summarizing the evidence-based or informed strategy measures (ESMs).

This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number U02MC31613, MCH Advanced Education Policy, $3.5 M. This information or content and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.

INTRODUCTION


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INTRODUCTIONStrengthen the Evidence Base for Maternal and Child Health Programs is a Health Resources and Services Administration (HRSA)-funded initiative that aims to support states in their development of strategies to promote the health and well-being of maternal and child health (MCH) populations in the United States (U.S.). This initiative, carried out through a partnership among the Georgetown University National Center for Education in Maternal and Child Health (NCEMCH), the National Maternal and Child Health Workforce Development Center (NMCHWDC) with assistance from the Association of MCH Programs (AMCHP), CityMatCH, and the Georgetown University Center for Child and Human Development (GUCCHD), was undertaken to facilitate implementation of the transformed State Title V MCH Services Block Grant to States program (hereafter referred to as the MCH Block Grant).22

One goal of the Strengthen the Evidence initiative is to conduct reviews that provide evidence of the effectiveness of possible strategies to address the National Performance Measures (NPMs)23 selected for the 5-year cycle of the MCH Block Grant program, beginning in fiscal year 2016. States are charged to select five NPMs, according to their identified priority needs, and incorporate evidence-based or evidence-informed strategies to achieve improvement for each NPM selected.

According to HRSA’s Maternal and Child Health Bureau (HRSA MCHB), the 15 NPMs were determined using the following criteria:24

• There is a large investment of resources by states on MCH issues;• The measure is considered to be modifiable by Title V activities;• States could delineate measurable activities to impact the measure;• Significant disparities are shown to exist in MCH population groups;• Research indicates that the condition or activity has large societal costs; or• Research indicates that health promotion of the behaviors, practices, or policies has resulted in

improved outcomes.

Performance measure 14.1: Smoking–Pregnancy25 is the percent of women who smoke during pregnancy. By specifically focusing on interventions that promote smoking cessation during pregnancy, the aim of this evidence analysis review is to ensure that fewer women smoke while pregnant. The MCH Evidence team reviewed individual level smoking cessation interventions—psychosocial and pharmacological—as well as population-based, policy

22 https://mchb.tvisdata.hrsa.gov/uploadedfiles/Documents/blockgrantguidance.pdf23 The first NPMs for MCH were instituted in 1997. The three-tiered performance measurement system includes national outcome measures (NOMs), NPMs, and evidence-based/informed strategy measures (ESMs) (Kogan et al., 2015). 24 https://HRSA MCHB.tvisdata.hrsa.gov/PrioritiesAndMeasures/NationalPerformanceMeasures 25 NPM 14 is Smoking and is comprised of two sub-topics. NPM 14.2 is Smoking—Household and there is a separate evidence analysis report for evidence-informed and evidence-based interventions to decrease child exposure to second-hand smoke by reducing the number of households where someone smokes.

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interventions. Becoming smoke-free before, during, and after pregnancy is vitally important for the health and well-being of the mother and baby in the short- and long-term.

ONLINE TOOLSThe report is supplemented by implementation resources for Title V programs that can be found in the MCH Evidence website’s NPM 14 Toolkit at https://www.mchevidence.org/tools/npm/ 14-smoking.php.

These resources include links to introductory information, a summary of the evidence, examples of promising practices, sample evidence-based or informed strategy measures (ESMs), links to current, related ESMs in process across the country, learning opportunities, and resources from the leading proponents of reducing smoking during pregnancy.

BACKGROUNDThis section lists Title V programs that selected NPM 14.1 in the 2018 grant application, summarizes national data, provides an overview of the issue, outlines the health risks, cites evidence on the impact and effectiveness of interventions, and describes the aim and focus of this evidence analysis review.

National Performance MeasureSmoking in pregnancy as a National Performance Measure (NPM). Smoking in pregnancy is one of the fifteen MCH National Performance Measures (NPMs). For the current year, 26 states, territories, and jurisdictions selected NPM 14: Smoking.26 More specifically, 13 states selected NPM 14.1: Smoking–Pregnancy including Florida, Idaho, Indiana, Kansas, Nevada, New Hampshire, New Jersey, Ohio, Pennsylvania, South Carolina, Vermont, Wisconsin, and Wyoming.27 Twelve states selected both NPM 14.1 and NPM 14.2 including Arizona, Colorado, District of Columbia, Guam, Maine, Maryland, North Carolina, Missouri, Oregon, Tennessee, Texas, and West Virginia.28

NPM 14.1 focuses on the percent of women who smoking during pregnancy. (Note that in parallel, the Healthy People 2020 objective is to increase smoking cessation during pregnancy.) This evidence analysis review focuses specifically on individual level and population-based interventions to decrease the number of women who smoke during pregnancy. Interventions ranged from psychosocial interventions, such as counseling, incentives, and feedback, to pharmacological interventions, such as nicotine replacement therapy (NRT), as well as policy-

26 Arizona, Colorado, District of Columbia, Florida, Guam, Kansas, Kentucky, Idaho, Indiana, Maine, Maryland, Missouri, Nevada, New Hampshire, New Jersey, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Wisconsin, West Virginia, and Wyoming (https://mchb.tvisdata.hrsa.gov/PrioritiesAndMeasures/NPMDistribution)27 https://mchb.tvisdata.hrsa.gov/PrioritiesAndMeasures/NPMDistribution28 https://mchb.tvisdata.hrsa.gov/PrioritiesAndMeasures/NPMDistribution

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related interventions, including smoke-free legislation, smoking bans, media campaigns, and tobacco taxation. There are separate and extensive bodies of literature associated with each of these approaches. This evidence analysis review focuses on the most current interventions to encourage maternal smoking cessation and/or reduction during pregnancy.

Evidence-based or informed Strategy MeasureSmoking in pregnancy Evidence-based or informed Strategy Measures (ESMs). Across the states and jurisdictions that chose smoking in pregnancy as one of the NPMs, there are 38 ESMs that have been chosen by Title V agencies to monitor progress in advancing NPM 14.1. These ESMs fall into three categories:• 8 represent activities directed to professionals (e.g., training activities, technical assistance),• 24 are directed to families and their children (e.g., outreach materials to families, family-to-

family support, development of care coordination plans), and• 6 represent activities related to systems-building (e.g., engagement of stakeholder groups,

quality improvement initiatives, collaboration between systems of care).

Findings from this report—specifically the evidence-based and evidence-informed interventions identified—can be used by Title V programs as models to strengthen current ESMs or develop new measures to effect change for each of these categories.

Against a matrix of the “MCH Pyramid,”29 the conceptual framework for services of the Title V MCH Block Grant program, of the 38 ESMs that focus on NPM 14.1:30

• 24 measure activities related to public health services and systems (foundational level of the pyramid),

• 9 measure strategies related to enabling services (middle level of the pyramid), and• 5 Title V programs are currently funding strategies related to direct services in regards to

reducing smoking in pregnancy (gap-filling level of the pyramid).

29 Title V Maternal and Child Health Services Block Grant to the States Program: Guidance and Forms for the Title V Application/Annual Report (OMB No. 0915-0172; Expires 12/31/2020).30 The conceptual framework for the services of the State Title V MCH Block Grant is envisioned as a pyramid with three tiers of services and levels of funding that provide comprehensive services. A goal is to “move on down” the pyramid with more states and jurisdictions engaging in public health services and systems. See https://mchb.tvisdata.hrsa.gov/Glossary/Glossary for a graphical representation of the pyramid.

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MCH Pyramid

The MCH Evidence Center uses Results-Based Accountability (RBA)31 as a conceptual framework to track how ESMs are measured. This framework consists of increasing levels of measurement across four quadrants (Quadrant 1 being the simplest measurement and Quadrant 4 being the most complex). States and jurisdictions should focus efforts in expanding how they measure programs by moving up the RBA quadrant scale.32, 33

• 32 current smoking in pregnancy ESMs measure effort: – 19 ESMs fall within Quadrant 1 (measuring the quantity of agency effort) and answer the question “what did we do?” (e.g., counts and “yes/no” activities).

– 13 ESMs fall within Quadrant 2 (measuring the quality of effort) and answer the question “how well did we do it?” (e.g., reach, quality of materials, satisfaction of intervention).

• 6 current smoking in pregnancy ESMs measure effect (e.g., increases in skills/knowledge, change in behavior or circumstance): – 5 ESMs fall within Quadrant 3 (measuring the quantity of the effect) to answer the question “is anyone better off?” (e.g., numbers of providers with increased knowledge).

– 1 ESM falls within Quadrant 4 (measuring the quality of the effect) and answer “how are they better off?” (e.g., percentages of families whose self-efficacy improved).

31 RBA is described in the RBA Implementation Guide http://raguide.org/index-of-questions/32 ESM Review & Resources: National Summary https://www.mchevidence.org/documents/ESM-Review-National-Summary.pdf33 To search the MCH Library to find state ESMs, visit: https://www.mchlibrary.org/evidence/state-esms.php

MCH Essential Services1. Provide Access to Care2. Investigate Health Problems3. Inform and Educate the Public4. Engage Community Partners5. Promote/Implement Evidence-Based Practices6. Assess and Monitor MCH Health Status7. Maintain the Public health Work Forces8. Develop Public Polices and Plans9. Enforce Public Health Laws10. Ensure Quality Improvement

Public Health Services and Systems

DirectServices

Enabling Services

Public Health Services for MCH Populations: The Title V MCH Services Block Grant

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FOUR CATEGORIES OF MEASUREMENT

Details of interventions tracked through ESMs can be found through the MCH Digital Library’s search page and used as models when considering new programs.34 The final section of this report, From Evidence to Action, outlines how to translate the evidence base into meaningful, achievable, and measurable strategies and directs readers to sample ESMs based on this report.

National Survey DataThe National Vital Statistics System (NVSS) is the oldest and most successful example of inter-governmental data sharing in public health and the shared relationships, standards, and procedures enable the Center for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS) to collect and disseminate the nation’s official vital statistics.35 The 2003 revision of the U.S. Standard Certificate of Live Birth included new and modified items on maternal cigarette smoking before and during pregnancy.36 The 2016 natality data file is the first for which this self-report37 information is available for all states and the District of Columbia (D.C.).38 Cigarette smoking during pregnancy was shown to differ across states, as well as by maternal age, race and Hispanic origin, and educational attainment.39

34 https://www.mchlibrary.org/evidence/state-esms.php 35 https://www.cdc.gov/nchs/nvss/index.htm36 https://www.cdc.gov/nchs/products/databriefs/db305.htm37 Given that these data are self-report and the stigma associated with smoking during pregnancy, there is the possibility that women underreported smoking while pregnant. 38 https://www.cdc.gov/nchs/products/databriefs/db305.htm39 https://www.cdc.gov/nchs/data/databriefs/db305.pdf

What did we do?Quantity of effort; lowest measurement

How much service did we deliver?

Examples: # individuals served, # referrals

Is anyone better off (#)?Quantity of effort; begins to measure improvement

How much change for the better did we produce?

Explanation: # individuals who show improvement in skills, knowledge, attitude, behavior or circumstance

Example: # individuals who received advanced treatment

Is anyone better off (%)?Quality of effect; highest measurement

What quality of change for the better did we produce?

Explanation: % individuals who show improvements in skills, knowledge, attitude, behavior, or circumstance

Example: % individuals who received advanced treatment

Is anyone better off (#)?Quality of effect; better measure than #1

How well did we deliver service?

We try to measure reach and satisfaction/quality of services

Examples: % individuals served % referrals, % respondents satisfied with services

Effort

Effect

GOALSMove from measuring quantitiy to quality

Move from measuring effort to effect

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“Identifying maternal characteristics linked with smoking during pregnancy can help inform the development of strategies to reduce the prevalence of maternal smoking and increase smoking cessation during pregnancy in the United States.” — DRAKE, DRISCOLL & MATTHEWS, 2018, p. 540

The 2016 data revealed that 7.2% of women who gave birth that year smoked cigarettes during pregnancy.41 This translates to 1 in 14 women smoking while pregnant.42 Maternal smoking during pregnancy was most common among women aged 20-24, non-Hispanic American Indian or Alaska Native mothers, and women with a high school education or less.43 More specifically:• With regard to age, the prevalence of smoking during pregnancy was highest for women aged

20-24 (10.7%), followed by women aged 15-19 (8.5%), and then those aged 25-29 (8.2%);• By race and ethnicity, Non-Hispanic American Indian or Alaska Native women had the highest

prevalence of smoking during pregnancy (16.7%) and non-Hispanic Asian women had the lowest (0.6%);

• Education-wise, the prevalence of smoking during pregnancy was highest among women who completed a high school education (12.2%), and the second-highest was among women with less than a high school education (11.7%);

• Compared to the nation overall, smoking during pregnancy was lower in 19 states and D.C. and higher in 31 states;

• The prevalence was highest in West Virginia (25.2%), Kentucky (18.4%), Montana (16.5%), Vermont (15.5%), and Missouri (15.3%); and

• The prevalence was lowest in Arizona, California, Connecticut, Hawaii, New Jersey, New York, Nevada, Texas, Utah, and D.C., each with a prevalence of less than 5%.44

OverviewSmoking is one of the most important modifiable causes of poor pregnancy outcomes in the U.S., and is associated with maternal, fetal, and infant morbidity and mortality (American College of Obstetricians and Gynecologists (ACOG), 2017). According to the Centers for Disease Control and Prevention (CDC), smoking reduces a woman’s chances of getting pregnant, increases the risk for pregnancy complications, and harms babies before and after they are born.45 The U.S. Surgeon General reports that women who smoke, like men, are at increased risk of cancer, cardiovascular disease, pulmonary disease, and premature death; but they also experience unique risks related to menstrual and reproductive function (Office on Smoking and Health, 2001). Smoking harms many aspects and every phase of reproduction (USDHHS, 2004). More specifically, women who smoke are at an increased risk of infertility with more difficulty

40 https://www.cdc.gov/nchs/data/databriefs/db305.pdf41 https://www.cdc.gov/nchs/products/databriefs/db305.htm42 https://www.cdc.gov/nchs/products/databriefs/db305.htm43 https://www.cdc.gov/nchs/data/databriefs/db305.pdf44 https://www.cdc.gov/nchs/products/databriefs/db305.htm45 https://www.cdc.gov/tobacco/basic_information/health_effects/pregnancy/index.htm

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becoming pregnant and a higher risk of never becoming pregnant (USDHHS, 2010a; USDHHS, 2004). Studies also suggest a relationship between tobacco and miscarriage, an unexpected loss of the fetus (USDDHS, 2010a). Women can also experience an ectopic pregnancy when the fertilized egg implants outside the uterus where the fetus develops, which usually results in miscarriage.46

“Smoking in pregnancy is the most preventable cause of illness and death among mothers and infants.” — CDC47

Nicotine is an addictive substance found in all tobacco products. Tobacco addiction is caused by the nicotine in tobacco causing a cascade of actions including the release of “pleasure enhancing” dopamine (Coleman et al., 2015; Schmidt, 2004). This strengthens associations of positive feelings with smoking behavior and seems to be involved in all addictive behaviors (Coleman et al., 2015; Schmidt, 2004). Nicotine and other harmful compounds in cigarettes are developmental toxicants (Rogers 2009) and can damage a baby’s brain and lungs.48 For pregnant women, the nicotine in cigarettes may cause constrictions in the blood vessels of the umbilical cord and uterus, thereby decreasing the amount of oxygen available to the fetus and reducing the amount of blood in the fetal cardiovascular system (USDHHS, 2004). Carbon dioxide in tobacco smoke can also keep the developing fetus from getting enough oxygen (USDDHS, 2010b). Additionally, e-cigarettes49 and other tobacco products containing nicotine are not safe to use during pregnancy.50 Flavorings used in e-cigarettes may be harmful to a developing fetus as well.51 Researchers report that infants born to women who use smokeless tobacco during pregnancy have high levels of nicotine exposure, low birth weight, and shortened gestation age that parallel the adverse effects experienced by women who smoked while pregnant (Hurt et al., 2005; Gupta et al., 2010).

Risks associated with smoking in pregnancy. Smoking is a public health problem due to the many adverse effects associated with it (ACOG, 2017). Smoking during pregnancy increases the risk of health problems for both mothers and babies, such as pregnancy complications, premature birth, low birth weight, stillbirth, infant death, and birth defects of the mouth and lip, as well as possible cognitive effects associated with learning disabilities and conduct disorders (DiFranza

46 https://women.smokefree.gov/pregnancy-motherhood/quitting-while-pregnant/smoking-your-baby47 https://www.cdc.gov/pregnancy/during.html48 https://www.cdc.gov/reproductivehealth/maternalinfanthealth/substance-abuse/substance-abuse-during-pregnancy.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Freproductivehealth%2Fmaternalinfanthealth%2Ftobaccousepregnancy%2Findex.htm#tobacco49 Although e-cigarettes are not a focal point of this review, it is a critical emerging issue in need of attention. See the evidence review for NPM 14.2: Smoking–Household for more information. 50 https://www.cdc.gov/reproductivehealth/maternalinfanthealth/substance-abuse/substance-abuse-during-pregnancy.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Freproductivehealth%2Fmaternalinfanthealth%2Ftobaccousepregnancy%2Findex.htm#tobacco51 https://www.cdc.gov/reproductivehealth/maternalinfanthealth/substance-abuse/substance-abuse-during-pregnancy.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Freproductivehealth%2Fmaternalinfanthealth%2Ftobaccousepregnancy%2Findex.htm#tobacco

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& Lew, 1995; Drews et al., 1996; Fiore et al., 2008; Makin et al., 1991; USDHHS, 2004; Wakschlag et al., 1997). An estimated 5-8% of preterm deliveries, 13-19% of term deliveries of infants with low birth weight, 23-34% of cases of sudden infant death syndrome (SIDS), and 5-7% of preterm-related deaths can be attributed to prenatal maternal smoking (Dietz et al., 2010). Women who quit smoking before or during pregnancy reduce the risk for adverse reproductive outcomes.

The adverse effects52 include the following:• Once pregnant, women who smoke are about twice as likely to experience complications, such

as placenta previa, a condition where the placenta grows too close to the opening of the uterus. This frequently leads to delivery by a Caesarean section (USDHHS, 2004).

• Pregnant women who smoke are also more likely to have placental abruption, where the placenta prematurely separates from the wall of the uterus. This can lead to pre-term delivery, stillbirth, or early infant death. Estimates for risk of placental abruption among smokers range from 1.4 to 2.4 times that of nonsmokers (USDHHS, 2004).

• Pregnant smokers are also at higher risk for premature rupture of membranes, which is breakage of the amniotic sac before the onset of labor. This makes it more likely that a smoker will carry her baby for a shorter than normal gestation period (USDHHS, 2004).

• Smoking doubles the risk of abnormal bleeding during pregnancy and delivery putting both the mother and baby in danger (National Cancer Institute (NCI)).53

• Smoking during pregnancy can cause tissue damage in the unborn baby, particularly in the lung and brain. The damage can last through childhood and into the teenage years (USDHHS, 2014).

• Mothers who smoke are more likely to deliver their babies early. A baby born 3 weeks or more before the due date (before the start of the 37th week of pregnancy) is considered premature. Babies born too early miss important growth that happens in the womb during the final weeks and months of pregnancy. Pre-term delivery is a leading cause of death, disability, and disease among newborns (NCI,54 USDDHS, 2010a; USDHHS, 2010b).

• The risk for having a baby in the smallest 5% to 10% of birth weights is as high as 2.5 times greater for pregnant smokers. One in 5 babies born to mothers who smoke during pregnancy has low birth weight. Low birth weight is a leading cause of infant deaths resulting in more than 300,000 deaths annually in the U.S. (USDHHS, 2004). – In general, pregnant smokers eat more than pregnant nonsmokers, yet their babies weigh less than babies of nonsmokers. This weight deficit is smaller if smokers quit early in their pregnancy (USDHHS, 2004).

– Mothers who are exposed to secondhand smoke (SHS) while pregnant are more likely to have lower birth weight babies. Prenatal SHS exposure increases the risk of having an infant with low birth weight by as much as 20% (Hegaard, 2006).

52 For unknown reasons, smokers are less likely to have preeclampsia, a condition that results in high blood pressure and an excess of protein in the urine (USDHHS, 2004).53 https://women.smokefree.gov/pregnancy-motherhood/quitting-while-pregnant54 https://women.smokefree.gov/pregnancy-motherhood/quitting-while-pregnant

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• Some studies suggest a link between maternal smoking and cleft lip, cleft palate, or both. A cleft is an opening in the baby’s lip or in the roof of the mouth (palate). This may lead to trouble with eating properly and is likely to require surgery (USDHHS, 2014; CDC55).

• Smoking during and after pregnancy increases the risk of SIDS, a term used to describe the sudden and unexpected death of a baby less than 1 year old in which the cause is not obvious before investigation (CDC).56 Babies whose mothers smoke are about three times more likely to die from SIDS (USDHHS, 2010b). – Babies whose mothers smoke while pregnant or who are exposed to SHS after birth have weaker lungs than other babies, increasing the risk for many health problems (USDHHS 2010a, USDHSS 2010b, USDHHS 2006).57

– Babies who breathe SHS have more lung infections than other babies. – SHS causes children who already have asthma to have more frequent and severe attacks. – Children exposed to SHS are more likely to develop bronchitis, pneumonia, and ear infections.58

• Children born to mothers who smoke during pregnancy are at increased risk of asthma, infantile colic, and childhood obesity (Li et al., 2005; Sondergaard et al., 2001; von Kries et al., 2002).59

“Research has shown that women’s smoking during pregnancy increases the risk of pregnancy complication, premature delivery, low birth weight infants, stillbirth, and sudden infant death syndrome.” — CDC60

Despite having increased knowledge of the adverse health effects of smoking during pregnancy, many pregnant women and teenage girls continue to smoke. Among U.S. women who smoked at conception, only 23% self-reported having quit smoking during pregnancy (Kim et al., 2009). In 2013, with an absolute number of births of around 4 million in the U.S., about 340,000 fetuses were directly exposed to tobacco in utero (Berlin et al., 2017). Eliminating maternal smoking may lead to a 10% reduction in all infant deaths and a 12% reduction in deaths from perinatal conditions (Office on Smoking and Health, 2001). Relevant studies suggest that infants of women who stop smoking by the first trimester have weight and body measurements comparable with those of nonsmokers’ infants (Office on Smoking and Health, 2001). Although quitting smoking before 15 weeks of gestation produces the greatest benefits for the pregnant woman and fetus, quitting at any point during pregnancy can be beneficial (England et al., 2001). Successful smoking cessation before the third trimester can eliminate much of the reduction in birth weight caused by maternal smoking (England et al., 2001). Studies suggest that smoking

55 https://www.cdc.gov/tobacco/campaign/tips/diseases/pregnancy.html56 https://www.cdc.gov/sids/about/index.htm57 Refer to the evidence review for NPM 14.2: Smoking–Household to learn more about the health effects of SHS exposure on children and effective strategies to decrease exposure.58 https://smokefree.gov/quit-smoking/why-you-should-quit/secondhand-smoke59 https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/10/smoking-cessation-during-pregnancy60 https://www.cdc.gov/tobacco/data_statistics/sgr/2004/highlights/children/index.htm

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in the third trimester is particularly detrimental. The benefits of reduced cigarette smoking are difficult to measure or verify.61

“Studies suggest that infants of women who stop smoking by the first trimester have weight and body measurements comparable with those of nonsmokers’ infants. Studies also suggest that smoking in the third trimester is particularly detrimental.” — CDC62

Health inequities and maternal smoking. While the majority of women understand that tobacco use damages health, for many smoking is a means of coping with poverty, disadvantage, and lack of control over other aspects of life (Graham, 1993). The key factors that contribute to smoking in pregnancy are caring responsibilities, access to material resources, and having a partner who smokes (Dolan-Mullen, 2004). It was also found that maternal stress and relationship discord may inhibit smoking cessation during and after pregnancy (Hauge, 2012). As such, for some pregnant women, smoking may be a way to alleviate stress and if they are grappling with other addictive behaviors, then quitting smoking may not be the highest priority. Women who continue to smoke in pregnancy are more likely to have a low income, higher parity, no partner, low levels of social support, and limited education, and they are more likely to access publicly funded maternity care, and more likely to feel criticized by society (Ebert 2007; Frost 1994; Graham 1977; Graham 1996; Pickett 2009; Schneider 2008; Smedberg 2014; USDHHS 2004; Wakschlag 2003). There is a clear link between smoking in pregnancy and social disadvantage; the greater the disadvantage, the higher the smoking prevalence.63 As such, there is a need to reduce smoking in pregnancy for all women, with a special focus on the needs of those who experience social disadvantage.64

“Given the strong association between social inequalities and continued smoking in pregnancy, health professionals need to support strategies in the wider community to reduce inequalities.” — PUBLIC HEALTH AGENCY65

In high-income countries, such as Australia, Canada, Denmark, New Zealand, Sweden, the United Kingdom (U.K.) and the U.S., the prevalence of smoking in pregnancy has declined from between 20% to 35% in the 1980s to between 10% and 20% in the early 2000s (Al-Sahab 2010; Chamberlain et al., 2017; Cnattingius 2004; Dixon 2009; Giovino 2007; Tappin 2010; Tong 2009; USDHHS 2004), with significant declines in the last decade bringing the prevalence of smoking in pregnancy well below 10% by 2010 (Lanting 2012). However, the decline has not been consistent across all sectors of society, with lower rates of decline among women with

61 https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/10/smoking-cessation-during-pregnancy62 https://www.cdc.gov/tobacco/data_statistics/sgr/2001/highlights/outcomes/index.htm63 https://www.publichealth.hscni.net/sites/default/files/Guide%203%20Reducing%20Smoking%20in%20Pregnancy.pdf64 https://www.publichealth.hscni.net/sites/default/files/Guide%203%20Reducing%20Smoking%20in%20Pregnancy.pdf65 https://www.publichealth.hscni.net/sites/default/files/Guide%203%20Reducing%20Smoking%20in%20Pregnancy.pdf

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lower socio-economic status (Graham 2010; Johnston 2011; Lanting 2012; Pickett 2009; USDHHS 2004). Tobacco smoking in high-income countries is a marker of social disadvantage and has been cited as one of the principal causes of health inequities between rich and poor (Wanless 2004).

In the U.S., increased public health education measures and public health campaigns have led to a decrease in smoking by pregnant and non-pregnant women of reproductive age (Colman & Joyce, 2003). Pregnancy itself is also a strong motivator. Women are more than likely to stop smoking during pregnancy, both spontaneously and with assistance, than at other times in their lives (Office on Smoking and Health, 2001). Approximately 46% of pre-pregnancy smokers quit smoking directly before or during pregnancy (Colman & Joyce, 2003). Although the rate of reported smoking during pregnancy has decreased overall, for some populations, such as adolescent females and non-Hispanic white and American Indian women with less education, the decrease was not as dramatic (Martin et al., 2009; Tong et al., 2009).

Since a mother-to-be is generally highly motivated to do what she can to have a healthy baby, clinical providers can tap into that motivation, capitalizing on a “teachable moment” to help parents achieve long-term healthy lifestyle changes for themselves and their families (ACOG, 2011). Using pregnancy-specific programs can increase smoking cessation rates, which benefits infant health and is cost effective (Office on Smoking and Health, 2001). However, only one-third of women who stop smoking during pregnancy are still abstinent one year after the delivery of their child (Office on Smoking and Health, 2001). Programs that encourage women to stop smoking before, during, and after pregnancy—and not to take up smoking ever again—deserve high priority for two reasons: during pregnancy women are highly motivated to stop smoking, and they still have many remaining years of potential life (Office on Smoking and Health, 2001). ACOG recommends that providers initiate a compassionate intervention with pregnant women who smoke.66

TIMING OF HEALTH BENEFITS AFTER QUITTING SMOKING

Time since quitting Benefits20 minutes Your heart rate drops.12 hours Carbon monoxide level in your blood drops to normal.2 weeks to 3 months Your heart attack risk begins to drop. Your lung function begins to improve.1 to 9 months Your coughing and shortness of breath decrease.1 year Your added risk of coronary disease is half that of a smoker’s.5 to 15 years Your stroke risk is reduced to that of a nonsmoker’s.10 years Your lung cancer rate is about half that of a smoker’s.15 years Your risk of coronary heart disease is back to that of a nonsmoker’s.

— USDHHS, 2004; ACOG, 2011

66 https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/10/smoking-cessation-during-pregnancy

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Stigma and smoking. The strong social norms discouraging smoking among pregnant women may lead some women to withhold disclosure of their true smoking status, as detected by measurement of urine cotinine, a nicotine metabolite (Spencer & Cowans, 2013; Swamy et al, 2011). For example, a retrospective cohort study comparing maternal urinary cotinine levels with self-reported cigarette use noted that 16.5% of women tested positive for high-level nicotine exposure and an additional 7.5% tested positive for low-level exposure despite a self-reported cigarette use rate of 8.6% (Hall et al., 2016). With most studies relying on under-reported self-reported smoking behavior, it is difficult to estimate the true prevalence of smoking during pregnancy. Although the use of urinary cotinine screening for pregnant women seems to be a feasible practice that could help increase the detection of smoke exposure among pregnant women, it is important to consider the lingering stigma associated with smoking in pregnancy and conduct screenings in a sensitive manner to fully support the health and well-being of the mother-to-be.

Clinical practice guidelines and clinical intervention strategies. National and state organizations have put forth clinical guidance and best practice guidelines to support smoking cessation during pregnancy and to diminish child exposure to SHS. In 2008, an update was published for the U.S. Public Health Service-sponsored Clinical Practice Guideline on tobacco use and dependence. The Guideline urged every clinician, health plan, and health care institution to make treating tobacco dependence a top priority during clinical visits and ask patients two key questions, “Do you smoke?” and “Do you want to quit?” followed by use of the recommendations in the Guideline. The Guideline recommends that health professionals follow a brief, evidence-based cessation intervention known as the “5 A’s: Ask about tobacco use, Advise tobacco users to quit, Assess willingness to make a quit attempt, Assist tobacco users in making a quit attempt, and Arrange for follow-up” (Fiore et al., 2008).

This approach was originally published by the NCI and has been reviewed and updated by governmental, academic, and private education groups (Glynn, 1990, Melvin et al., 2000, Fiore et al., 2008). The 5 A’s method for brief interventions has substantial research support for its utility in helping tobacco users across a variety of settings and can be incorporated with motivational strategies in a step-by-step process.67 Continuing the 5 A’s approach after a woman gives birth helps her continue her efforts to quit smoking or maintain smoking cessation (ACOG, 2011). For patients who relapse, clinicians should revisit the 5 A’s and keep reiterating the positive effects of quitting (ACOG, 2011). Although some professional organizations endorse a modified three-step process “Ask, advise, and refer,” this method has not been proven to be effective in pregnancy (ACOG, 2011).

67 https://mdquit.org/cessation-programs/brief-interventions-5

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EVIDENCE-BASED GUIDELINES: THE FIVE A’S OF SMOKING CESSATION68

1. ASK the patient about smoking status at the first prenatal visit and follow-up with her at subsequent visits. If the patient stopped smoking before or after she found out she was pregnant, reinforce her decision to quit, congratulate her on success in quitting, and encourage her to stay smoke-free throughout pregnancy and postpartum. If the patient is still smoking, document smoking status in her medical record, and proceed to Advise, Assess, Assist, and Arrange.

2. ADVISE the patient who smokes to stop by providing advice to quit with information about the risks of continued smoking to the woman, fetus, and newborn.

3. ASSESS the patient’s willingness to attempt to quit smoking at the time. Quitting advice, assessment, and motivational assistance should be offered at subsequent prenatal care visits.

4. ASSIST the patient who is interested in quitting by providing pregnancy-specific, self-help smoking cessation materials. Support the importance of having a smoke-free space at home and seeking out a “quitting buddy,” such as a former smoker or nonsmoker. Encourage the patient to talk about the process of quitting. Offer a direct referral to the smokers’ quit line (1-800-QUIT-NOW) to provide ongoing counseling and support.

5. ARRANGE follow-up visits to track the progress of the patient’s attempt to quit smoking. For current and former smokers, smoking status should be monitored and recorded throughout pregnancy, providing opportunities to congratulate and support success, reinforce steps taken towards quitting, and advise those still considering a cessation attempt (Fiore et al., 2008; Melvin et al., 2000; ACOG, 2010).

Additional Guideline recommendations:• Because of the serious risks of smoking to the pregnant smoker and the fetus, whenever

possible pregnant smokers should be offered person-to-person psychosocial interventions that exceed minimal advice to quit (Strength of evidence = A).69

• Although abstinence early in pregnancy will produce the greatest benefits to the fetus and expectant mother, quitting at any point in pregnancy can yield benefits. Therefore, clinicians should offer effective tobacco dependence interventions to pregnant smokers at the first prenatal visit as well as throughout the course of pregnancy (Strength of evidence = B).70

In October 2017, the ACOG Committee on Health Care for Underserved Women and the Committee on Obstetric Practice published an opinion on smoking cessation during pregnancy.71 It stated that, “Although the physical and psychologic addiction to cigarettes is powerful, the compassionate intervention of the obstetrician-gynecologist can be the critical element in

68 https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Smoking-Cessation-During-Pregnancy?IsMobileSet=false69 A: Multiple well-designed randomized clinical trials, directly relevant to the recommendation, yielded a consistent pattern of findings (ACOG, 2011).70 B: Some evidence from randomized clinical trials supported the recommendations, but other scientific support was not optimal (ACOG, 2011). 71 This October 2017 Committee Opinion replaced the Committee Opinion from October 2010. In 2011, ACOG also published “Smoking Cessation During Pregnancy: A Clinician’s Guide to Helping Pregnant Women Quit Smoking,” a self-instructional guide and toolkit that helped further flesh out the previous opinion (https://www.acog.org/~/media/Departments/Tobacco%20Alcohol%20and%20Substance%20Abuse/SCDP.pdf).

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prenatal smoking cessation.”72 The Committee emphasized that inquiry into tobacco use and smoke exposure should be a routine part of the prenatal visit. The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians ask all pregnant women about tobacco use and provide augmented, pregnancy-tailored counseling for those who smoke (Siu, 2015). In particular, the USPSTF recommends that clinicians offer effective tobacco dependence interventions to pregnant smokers at the first prenatal visit as well as throughout the course of pregnancy (Fiore et al., 2008).

More specifically, the Committee highlighted the following strategies:• An office-based protocol that systematically identifies pregnant women who smoke and offers

treatment or referral has been proven to increase quit rates.• A short counseling session with pregnancy-specific educational materials and a referral to the

smokers’ quit line is also an effective smoking cessation strategy.• The 5 A’s is an office-based intervention developed to be used under the guidance of trained

practitioners to help pregnant women quit smoking.• Knowledge of the use of the 5 A’s, health care support systems, and pharmacotherapy add to the

techniques clinical providers can use to support perinatal smoking cessation.• The use of alternative forms of nicotine, such as e-cigarettes and vaping, have increased

substantially in recent years, but there is little data regarding the health effects of these agents, either in the general population or in pregnant women specifically.

“The way in which you talk to patients about their health can substantially influence their personal motivation for behavior change.” — ROLLNICK, MILLER, BUTLER & ALOIA, 2008, p. 6

Smoking cessation interventions for pregnant women. Widespread use of clinical guidelines and effective smoking cessation interventions are necessary to reduce health risks for mothers and babies and ensure their health and well-being in the short- and long-term. Successful strategies supported by clinical evidence are available and should be integrated into routine prenatal care for every pregnant woman (ACOG, 2011). Cessation of tobacco use, prevention of SHS exposure, and prevention of relapse to smoking are key clinical intervention strategies during pregnancy that should be offered to women (ACOG, 2008). Tobacco dependence interventions for pregnant women are particularly cost-effective because they reduce the number of low birthweight babies and perinatal deaths, decrease use of newborn intensive care units, shorten lengths of stay, and decrease service intensity (ACOG, 2011; Adams, 2004; Lightwood, 1999). Interestingly, a 2006 analysis revealed that implementation of a smoking cessation intervention, such as the 5 A’s, would cost from $24 to $34 and save $881 per U.S. pregnant smoker leading to a savings of up to $8 million in averted neonatal costs given a 70% increase in quit rates (ACOG, 2011; Ayadi, 2006).

72 https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/10/smoking-cessation-during-pregnancy

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“Efforts to develop effective cessation interventions for this population have been ongoing since the mid-1980s, involving more than 77 controlled trials and 29,000 women.” — HIGGINS & SOLOMON, 2016, p. 3

“Spontaneous quitters” usually smoke less and are more likely to have temporarily stopped smoking previously, have a non-smoking partner, have more support and encouragement at home for quitting, have stronger beliefs about the dangers of smoking, and are less seriously addicted (Baric, 1977; Ryan, 1980). Consequently, women who are eligible for smoking cessation assistance in pregnancy are likely to find it more difficult to quit than those in other populations (Coleman et al., 2015). Cessation techniques have included counseling, cognitive and behavioral therapy, hypnosis, acupuncture, and pharmacologic therapy (ACOG, 2008). These behavioral, economic, policy, and pharmaceutical approaches have been widely tested to promote smoking cessation during and after pregnancy. Tailoring intervention methods, identifying and addressing barriers to behavior change, and acknowledging the concerns of pregnant women can lead to greater acceptance of interventions (Windsor, Boyd & Orleans, 2004). These different intervention types are defined and described in more detail below.

Psychosocial interventions. Psychosocial interventions include counseling, health education, incentives, social support, structured support for physical activity, and feedback (Chamberlain et al., 2017).73 At the individual level, brief interventions are 5-10 minute focused conversations with a trained person; behavioral counseling can include individualized support from a cessation specialist; educational materials can include self-help resources; telephone counseling and quit lines are available for support; and group counseling programs are available. Incentives or rewards can include cash, vouchers, lottery tickets, prize draws, or other products or materials. Social support can involve peers, professionals, or partners (e.g., “quitpals”). Structured support for physical activity can include low impact exercise, such as treadmill walking. Feedback interventions give pregnant women information about the health of their fetuses and the levels of tobacco byproducts in their bodies (e.g., cotinine and carbon monoxide (CO) measurements) (Chamberlain et al., 2017).74

Strategies are delineated below by target population and intervention type:• Pregnant women who state that they are not ready to quit smoking can benefit from consistent

motivational approaches by their health care providers (ACOG Committee Opinion No. 423).75

• Pregnant women who are willing to quit smoking benefit from a brief counseling session, such as the 5 A’s intervention, which has proven to be effective when initiated by health care providers (Fiore et al., 2008). Quit line referrals may be of further benefit by offering information, direct support, and ongoing counseling, and have been very successful in helping pregnant smokers quit and remain smoke-free (ACOG, 2017; Tomson, Helgason & Gilljam, 2004). When callers dial the national quit line network (1-800-QUIT-NOW), they are routed to

73 https://www.healthypeople.gov/2020/tools-resources/evidence-based-resource/psychosocial-interventions-for-supporting-women-to-stop74 https://www.healthypeople.gov/2020/tools-resources/evidence-based-resource/psychosocial-interventions-for-supporting-women-to-stop75 https://journals.lww.com/greenjournal/Citation/2009/01000/ACOG_Committee_Opinion_No__423__Motivational.43.aspx

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their state’s smokers’ quit line. Many states also offer fax referral access to their quit lines for prenatal health care providers.

• Heavily addicted smokers should be encouraged to seek help to stop smoking at every prenatal follow-up visit. They may also benefit from screening and intervention for alcohol use and other drug use as well as additional psychosocial treatment (Fiore et al., 2008; Ockene et al., 2002) given the severity of their addiction.

• An incentive or reward can be an effective way of helping women quit smoking during pregnancy compared to usual care alone. However, abstinence does not continue post-pregnancy (Lumley et al., 2009).

• There is insufficient evidence to support the use of meditation, hypnosis, and acupuncture for maternal smoking cessation (Fiore et al., 2008).

• Pregnant women who are exposed to the smoking of family members or coworkers should be given advice on how to address or avoid SHS exposure (ACOG, 2017).

• It seems that the greatest impact occurs when several strategies are used in conjunction; providers can consider multicomponent interventions based on the individual needs of the women (e.g., counseling + health education + incentive) (West, McNeill & Raw, 2003).

“Financial incentives produce the largest effect sizes by several orders of magnitude compared to pharmacological or other psychosocial interventions.” — HIGGINS & SOLOMON, 2016, P. 3

Pharmacological interventions. It is recommended that women try to quit smoking without using pharmacologic agents, such as nicotine replacement therapy (NRT), bupropion, and varenicline, if at all possible. These have not been sufficiently tested for efficacy and safety in pregnant patients and should not be used as first-line smoking cessation strategies (ACOG, 2011). The evidence is also inconclusive as to whether smoking cessation medications boost abstinence rates in pregnant smokers (ACOG, 2011). Additionally, U.S. clinical trials with sufficient power to determine statistical significance have been pulled or ended due to data or safety monitoring issues (Fiore et al., 2008; ACOG, 2011). The USPSTF has concluded that current evidence is insufficient to assess the balance of benefits and harms of nicotine replacement products and other pharmaceuticals for smoking cessation during pregnancy (Siu, 2015; ACOG, 2017).

However, if pharmacotherapy is considered for pregnant smokers who are heavily addicted and unable to quit by other means, then it is critical that the woman demonstrate a resolve to quit smoking and to understand the benefits and risks of the use of the medication to herself and her fetus. Clinicians also need to carefully review patient information, drug side effect profiles, and current information in the medical literature when recommending pharmacologic aids (ACOG, 2011). Further, since antidepressants marketed for smoking cessation, such as bupropion, carry risks of adverse effects including increased risk for suicide, insomnia, and rhinitis, pregnant patients who choose these medications require close supervision and monitoring (ACOG, 2011).

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Taking a closer look at these pharmacotherapies:• Bupropion and varenicline are the only two drugs as yet approved by the Food and Drug

Administration (FDA) for smoking cessation that do not contain nicotine. Both of these medications have product warnings by the FDA about the risk of psychiatric symptoms and suicide associated with their use.76

• Bupropion is an antidepressant; its precise mechanism of action for smoking cessation remains uncertain. With only limited data, there is no known risk of fetal anomalies or adverse pregnancy effects (ACOG, 2008).

• A review of antidepressants for smoking cessation suggested that the mode of action of bupropion is independent of its antidepressant effect and that it is of similar efficacy to nicotine replacement (Hughes et al., 2014).

• Varenicline is believed to mimic the pleasurable dopaminergic (dopamine-releasing) effect of nicotine. Varenicline binds more easily to receptors than nicotine, so when abstinent smokers use this drug, receptors become blocked with varenicline. Should varenicline users choose to smoke, varenicline then prevents nicotine from attaching to receptors so this cannot cause any pleasurable effects for smokers (Coe, 2005). Consequently, smoking while using varenicline is less enjoyable and attractive for smokers who also experience fewer cravings or withdrawal symptoms and so, are better able to remain abstinent.

• Hughes et al. (2014) found evidence to suggest that bupropion is of similar efficacy to NRT, and that varenicline is more effective than NRT.

• Both medications are understudied among pregnant women.• Several small studies evaluating the safety of varenicline and bupropion in pregnancy did not

find evidence of teratogenicity (manifestation of developmental toxicity), but data are limited.• Both bupropion and varenicline are transmitted to breast milk. There is insufficient

evidence to evaluate the safety and efficacy of these treatments in pregnancy and lactation (Fiore et al., 2008).

• The use of alternative forms of nicotine, such as e-cigarettes and vaping, have increased substantially in recent years, but there are little data regarding the health effects of these agents, either in the general population or in pregnant women specifically (ACOG, 2017).

• These electronic nicotine delivery systems (ENDS) are being used by smokers in the belief that they will aid in smoking cessation efforts. A recent review of the use of ENDS revealed no robust evidence that these products aid in smoking cessation (ACOG, 2017; El Dib et al., 2017).

For mothers who smoke during the postpartum period, several pharmacologic smoking cessation aids are available, including nicotine replacement products, such as gum, patches, lozenges, nasal spray, and inhalers. Bupropion and varenicline are also prescribed as aids given their ability to help patients cope with nicotine withdrawal symptoms (ACOG, 2011). However, the FDA has placed black-box warnings on all antidepressants and varenicline as their use increases the risk

76 https://www.fda.gov/consumers/consumer-updates/want-quit-smoking-fda-approved-products-can-help

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of suicide, particularly in adolescents and young adults (ACOG, 2011). Again, users should be closely followed for suicidal ideation, and mothers who are breastfeeding should check with their pediatrician (ACOG, 2011).

Systematic ReviewsTwo recent systematic reviews provided the foundation for our evidence review. The objective of the Chamberlain et al. (2017) review was to assess the effects of smoking cessation interventions during pregnancy on smoking behavior and perinatal health outcomes. This was the sixth update of the Cochrane review of interventions to promote smoking cessation during pregnancy. The authors searched the Cochrane Pregnancy and Childbirth Group’s Trials Register and considered trials of psychosocial interventions where the primary aim of the study was smoking cessation in pregnancy. One hundred and two studies met inclusion criteria (n=102). Selected studies were categorized into seven main intervention strategies: Counseling, health education, feedback, incentives, social support, exercise, and other.77

In contrast, the objective of the Coleman et al. (2015) review was to determine the efficacy and safety of smoking cessation pharmacotherapies, including NRT, varenicline, and bupropion, and other medications, or ENDS, or e-cigarettes, when used for smoking in pregnancy. When used by non-pregnant smokers, pharmacotherapies are effective for smoking cessation; however, their efficacy and safety in pregnancy remains unknown. The authors searched the Cochrane Pregnancy and Childbirth Group’s Trials Register in November 2015 to update the previous 2012 review. Nine trials met inclusion criteria with 3 being new and 6 from the previous review (n=9). Of the 9 included studies, 8 investigated NRT and 1 looked at bupropion as adjuncts to behavioral support/cognitive behavioral therapy. These 9 trials enrolled a total of 2210 pregnant smokers. No studies used varenicline or ENDS.

Findings. The Chamberlain et al. (2017) review was unable to draw conclusions about statistical differences between intervention types performed on different comparison groups. This was because many combinations of intervention strategy and comparison type were poorly or not represented among the search results with relevant data; as such, no interaction analysis with these two variables was appropriate. About half (n=50) of studies selected for relevant primary outcome data compared counseling strategies with usual care (n=32) or a less intensive intervention (n=18). Selected studies (97 total) were categorized into seven main intervention strategies: Counseling (n=51), health education (n=11), feedback (n=6), incentives (n=13), social support (n=14), exercise (n=1), and other (n=1). Counseling, feedback and financial incentives appear to be effective in reducing the number of women who smoke late in pregnancy. The effect of health education, social support, and support for physical activity are less clear (Chamberlain et al., 2017).

77 The studies in this evidence review will use the same intervention categories for the psychosocial strategies.

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“Counseling, feedback and incentives appear to be effective. The effect of health education and social support is less clear.” — CHAMBERLAIN ET AL., 2017, p. 3

Results from Coleman et al. (2015) indicate that NRT used for smoking cessation increased rates measured in late pregnancy by approximately 40%. However, there is evidence suggesting that when potentially-biased, non-placebo randomized controlled trials (RCTs) are excluded from the analyses, NRT is no more effective than placebos. There is no evidence that NRT used for smoking cessation in pregnancy has either positive or negative impacts on birth outcomes. There were no differences between NRT and control groups in rates of miscarriage, stillbirth, premature birth, birthweight, low birthweight, admissions to neonatal intensive care, caesarean section, congenital abnormalities or neonatal death. There is some evidence that use of NRT promotes healthy developmental outcomes in infants (one trial; no other trials followed up with infants after the neonatal period) (Coleman et al., 2015).

“There is no evidence that nicotine replacement therapy used for smoking cessation in pregnancy has either positive or negative impacts on birth outcomes.” — COLEMAN ET AL., 2015, p. 2

Implications for practice. The authors of Chamberlain et al. (2017) concluded that psychosocial interventions can support women to quit smoking in pregnancy and should be considered for women who are pregnant or trying to become pregnant. There is also high-quality evidence that these interventions reduce the risks of infants being born with low birth weight and being admitted to neonatal intensive care units (NICUs) immediately after birth. Pregnant women in these studies expect and appreciate support to stop smoking and interventions are more likely to improve women’s psychological well-being.

In sum, the evidence from Chamberlain et al. (2017) suggests the following:• It seems that the provision of health education and risk advice alone is not sufficient;• Any psychosocial support should include additional intervention components to support women

to quit, such as counseling, incentives, or feedback;• Be cautious because some peer- and/or partner-support behaviors may be unhelpful, and may

potentially expose vulnerable women to increased risk;• Due to the high co-morbidity with psychological symptoms and the potential to improve

psychological well-being, interventions that include psychological support for women with symptoms should be considered; and

• Given that many women resume smoking after pregnancy, consideration should be given to messages that reinforce the benefits for the mother, rather than solely focusing on benefits for the infant.

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“There is little doubt about ‘whether’ psychosocial interventions are effective in reducing smoking during pregnancy or the proportion of infants born with low birth weight. What is not clear is ‘which’ interventions are effective, ‘how’ these interventions work, ‘who for’ and ‘how’ should these interventions be implemented, disseminated, and institutionalized.” — CHAMBERLAIN ET AL., 2017, p. 52

Lastly, the authors of Coleman et al. (2015) stated that there is weak evidence to suggest that NRT with behavioral support for smoking cessation in pregnancy is effective. NRT is already used quite widely in some jurisdictions and accruing evidence is that this clinical practice does no harm. For example, one study from this review followed up with babies after the neonatal period, and its results suggest that NRT used in pregnancy for smoking cessation results in improved child development. In actuality, there is no evidence that NRT has either a positive or negative impact on pregnancy and infant outcomes. Efficacy findings should be treated cautiously as their derivation includes data from non-placebo RCTs, which appear to have higher risks of bias. Excluding non-placebo NRT trials from this pooled analysis reveals that improvement over placebo was not statistically significant. As such, the authors rated the evidence that NRT could be effective for smoking cessation during pregnancy as weak and recommended further research (Coleman et al. 2015).

“Further research evidence on nicotine replacement therapy efficacy and safety is needed, ideally from placebo-controlled randomized control trials which achieve higher adherence rates and which monitor infants’ outcomes into childhood.” — COLEMAN ET AL., 2015, P. 2

To build upon these findings, this evidence review examines the effectiveness of the most recently published studies on smoking cessation during pregnancy to provide guidance and lay out considerations for Title V programs focused on decreasing the number of women who smoke while pregnant.

METHODSThis section describes the approach used for the evidence analysis review. It includes information on the search terms used, databases searched, inclusion and exclusion criteria, the multi-phase screening process, the grey literature screening process, and the evidence continuum that was used to rate the level of evidence for the studies.

Databases and Search TermsNumerous seminal and important documents were examined to provide context and grounding for the evidence analysis review. Two systematic reviews in particular provided the foundation for this review. The review by Chamberlain et al. (2017) focused on the effects of smoking

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cessation interventions during pregnancy on smoking behavior and perinatal health outcomes. The review by Coleman et al. (2015) looked at the efficacy and safety of smoking cessation pharmacotherapies, including NRT, varenicline, and bupropion, other medications, or ENDS when used for smoking cessation in pregnancy.

The former research team at JHU provided their search terms. Those search terms were used to run searches in PubMed, the Cumulative Index of Nursing and Allied Health Literature (CINAHL Plus), the Cochrane Library databases, and PsycINFO. Search strategies varied depending on the database due to differences in controlled vocabulary, indexing, and syntax. Table 1: Detailed Search Strategies highlights the search terms used for each database. The updated searches used for this evidence analysis review were performed in May 2019. A total of 4,317 articles were identified across the databases. After de-duplication, 3,619 articles titles were reviewed. Of these, 567 article titles seemed broadly relevant and moved onto the next round of abstract review. From there, 116 articles were reviewed in full by members of the research team. After extensive discussion by the team members, 42 studies were selected for inclusion in the results from this search of the most recent literature.

Inclusion and Exclusion CriteriaThe following inclusion criteria were used:• Studies evaluated the effectiveness of interventions aimed at smoking abstinence or smoking

cessation during pregnancy.• Mechanisms for the reduction of smoking during pregnancy include psychosocial and

pharmacotherapy techniques as well as policy-level approaches.• For studies that aim to improve broader maternal health outcomes, only the smoking cessation

and reduction outcomes were considered.• The components of the intervention and results were clearly described.• Studies described interventions that fall within the scope of Title V MCH Block Grant

programs as deemed by the authors and reviewers.• At a minimum, studies included a control and intervention group, an appropriate comparison

group, or a pretest-posttest design to assess intervention effectiveness.• Studies were published in English.• Studies were conducted primarily in high resource countries.• Studies were published in peer-reviewed journals.• Grey literature was included as promising practices.

The following exclusion criteria were applied:• Studies where the primary population was not pregnant women (e.g., non-pregnant women,

partners).• Studies focused primarily on smoking cessation after pregnancy (e.g., postpartum interventions).

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• Studies focused on what influences decisions to smoke (e.g., advertising, peer pressure) or not to cease smoking during pregnancy.

• Studies on the risk factors associated with smoking during pregnancy.• Studies on the effects of smoking during pregnancy on diseases, disorders, and morbidity

factors.• Articles focused on prevalence rates for smoking during pregnancy.• Studies focused on e-cigarettes, vaping, and/or hookahs and not tobacco smoke.• Articles focused on attitudes towards smoking during pregnancy.• Articles on forthcoming studies.• Articles reporting on study protocols only.• Studies focused on SHS or environmental tobacco smoke.78

Screening ProcessA multi-phase, sequential process was used to sort and identify articles, which included the following steps:• Grouping the literature:

– The research team began by reviewing 15 systematic reviews, seminal documents, and important resources to get an understanding of the literature and evidence base around smoking during pregnancy. This information can be found in the background section of this report.

– The Chamberlain et al. (2017) and Coleman et al. (2015) systematic reviews became the foundational documents for this report and are summarized in the systematic reviews sub-section.

– The most recent literature on smoking cessation during pregnancy was reviewed for inclusion/exclusion.

• Literature searches: – Extensive literature searches were used to identify relevant studies for decreasing smoking during pregnancy.• A PubMed search identified 2,360 articles (dates covered: January 2015-May 2019), date

run: May 8, 2019• A CINAHL search brought back 770 results (dates covered: January 2015-May 2019), date

run: May 8, 2019• A Cochrane Library search uncovered 794 articles (dates covered: January 2015-May

2019), date run: May 23, 2019• A PsycINFO search identified 393 articles (dates covered: January 2015-May 2019), date

run: May 27, 2019.

78 There is a separate evidence analysis review for 14.2: Smoking–Household.

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• De-duplication: – The 4,317 article titles were de-duplicated across the databases. – 698 duplicate article titles were deleted. – After de-duplication, 3,619 article titles moved on for title review.

• Article title review: – An initial review of article titles across the databases highlighted 567 article titles that seemed broadly relevant to different aspects of smoking cessation during pregnancy.

• Article abstract screening: – Abstract reviews (n=567) were divided up and conducted by 1 of 3 members of the research team; together the team discussed any articles that seemed questionable for inclusion in this review.

• Full text review: – Full text reviews were divided up and completed by 1 of 3 members of the team (n=116 studies from the database searches).79

– Team members extracted data pertaining to the study characteristics, intervention, and results. – Research team meetings were held to review decisions related to the full articles. Topics covered• Articles marked for exclusion.• Articles flagged as “maybe” or “include” for consideration in making final decisions about

what to include in this review. – The Principal Investigator and Director of Research met with the team to review methodology, decisions, and points of discussion.

– Of the 116 articles that went through full review from the database searches, 42 studies met the inclusion criteria.

– Articles that did not describe interventions, did not contain sufficient data, or did not directly measure smoking cessation during pregnancy but nevertheless presented lessons learned or critical issues for consideration when developing and delivering interventions to pregnant women are noted in the discussion.

See Figure 1: Flow Chart of the Review Process and Results for a visual display of these identification, screening, eligibility, and inclusion steps.

79 Due to time and resource constraints, included studies were divided among the 3 team members and each member summarized and rated a third of the studies. Bi-weekly meetings occurred to discuss evidence ratings and the team came to consensus on the ratings for the majority of studies; therefore, issues around inter-rater reliability were likely diminished.

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Evidence ContinuumAn evidence continuum was created80 to assess evidence-based and evidence-informed strategies, along with criteria for each category along the continuum. The Robert Wood Johnson Foundation (RWJF) What Works for Health evidence ratings81 were adapted to create an evidence continuum tailored toward the Strengthen the Evidence initiative. The evidence ratings include: 82

EVIDENCE RATING DEFINITION

Evidence Against Studies with this rating are not good investments. These strategies have been tested in many robust studies, are not effective, and sometimes produce harmful results.

Mixed EvidenceH

Strategies with this rating have been tested more than once and results are inconsistent or trend negative; further research is needed to confirm effects.

Emerging EvidenceH H

Strategies with this rating have limited research documenting effects. These strategies need further research, often with stronger designs, to confirm effects.

Expert OpinionH H H

Strategies with this rating are recommended by credible, impartial experts and are consistent with accepted theoretical frameworks. However, the strategies have limited research documenting effects; further research, often with stronger designs, is needed to confirm effects.

Moderate EvidenceH H H H

Strategies with this rating are likely to work, but further research is needed to confirm effects. These strategies have been tested more than once and results trend positive overall.

Scientifically RigorousH H H H H

Strategies with these ratings are most likely to make a difference. These strategies have been tested in many robust studies with consistently positive results.

Using an “evidence-informed” approach, a continuum of evidence model was developed to help states use the best available MCH science while also encouraging innovation in evidence-informed programming.83 Evidence-based strategies are generally those that have either moderate evidence or are scientifically rigorous, while evidence-informed are those that have emerging evidence or are based on expert opinion.84 Evidence-informed is meant to convey that there is information suggesting that a certain strategy could be effective in addressing a NPM. Even though these strategies have not been rigorously tested or evaluated, they may incorporate a theoretical model from other effective public health practices or apply a novel approach grounded in scientific theory.

More specifically, evidence-based strategies have a majority of studies showing statistically significant or favorable findings. These studies tend to be peer-reviewed with results mostly drawn from a mix of RCTs, quasi-experimental studies with pre-post measures, with or without control groups, and/or time trend analyses. Evidence-informed strategies have a growing

80 The former Strengthen the Evidence for MCH Programs initiative research team at JHU originally adapted the RWJF evidence ratings to create the evidence continuum for the evidence analysis reports.81 http://www.countyhealthrankings.org/take-action-improve-health/what-works-health/our-ratings 82 https://www.mchevidence.org/tools/ 83 The former Strengthen the Evidence for MCH Programs initiative worked to develop a continuum of evidence consistent with the evidence-informed approach84 This evidence-informed approach was defined by the McMaster group: McMaster University. Health Evidence Glossary. Available: http://www.healthevidence.org/glossary.aspx#E

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evidence base consisting of a varying mix of statistically favorable, unfavorable, and/or not significant findings. These studies can include peer-reviewed results as well as grey literature with a mix of study designs. Evidence against is a unique category wherein strategies could be labeled as evidence-based or evidence-informed, based on the state of the research, study design, and outcomes, with the preponderance of studies not having statistically significant findings or demonstrating unfavorable effects. See Table 2: Evidence Rating Criteria to learn about the evidence criteria applied to the studies. Evidence ratings were given for each included study as well as the different intervention types.85

RESULTSThis section provides an overview of the study characteristics, intervention components, data sources, outcome measures, study results, and limitations. The studies included in this evidence review varied in terms of the intervention type, setting, sample, design, and data sources. However, they represent attempts by researchers working in countries, states, jurisdictions, and communities to decrease the percent of women who smoke during pregnancy by focusing on cessation techniques. Interventions were grouped by major intervention type—psychosocial or pharmacotherapy—and then by specific strategy. The different intervention strategies are then rated for their collective level of evidence.

Characteristics of Studies ReviewedTable 3: Study Characteristics details the characteristics of the interventions selected for this evidence review and details the countries, settings, target populations, sample sizes, and study designs. Of the 42 studies, 16 were RCTs with 5 of those being pilot studies. Fourteen were quasi-experimental cross sectional studies, 6 were cohort studies, 4 were single group pre-posttest or prospective intervention evaluations, 1 was a qualitative interview study, and 1 was a mixed methods case series. With regard to country, 25 studies were conducted in the U.S., 11 in Europe, 2 in Australia, 2 in New Zealand, 1 in Canada, and 1 in China.

The target populations included women who are currently smoking or have recently quit smoking and are pregnant in any care setting, women who are currently smoking or have recently quit smoking and are seeking a pre-pregnancy consultation, and the health and birth records of women who reported or were biochemically verified smokers during pregnancy. A few interventions were focused on health care practitioners. The sample sizes ranged from 5 women to a records review of 800, 919 pregnancies with an average of 39,423 across all 42 studies.

In terms of setting, of the 42 studies, 24 studies (57%) were clinic-based interventions (e.g., obstetrical/prenatal/primary care clinics, community health centers, hospital delivery units), 3 studies (7%) were community-based interventions (e.g., home/residential health

85 The evidence continuum was originally created to be applied to intervention types; however, the rating scale was also used to rate each study in this review making some of the overarching criteria difficult to apply at times.

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care, community-based home visiting organizations), 10 (24%) of the studies were conducted electronically (e.g., phone applications, telephone, online), and 5 (12%) were policy interventions to increase smoke-free environments.

Intervention Types and ComponentsTable 4: Intervention Descriptions describes the interventions, comparison groups, study lengths, and data collection time points. The comparison group for the majority of the studies were usual/standard care (e.g., obstetrical/prenatal and 5 A’s or other standard smoking cessation in pregnancy package),86 historical record review, or minimal intervention, such as educational self-help materials only. The majority of studies (64%) had a comparison group, while 36% did not. Of the comparison group studies, 3 studies (7%) used either within group comparison or more than one intervention while 3 (7%) used pre-intervention historical records review. The study lengths ranged from 3 months to over 18 years of record reviews, with an average length of 3.7 years across all studies. Data collection tended to occur at the following intervals: pre-intervention, program or service initiation (enrollment, first prenatal visit, first ultrasound, or quit date), points of care (prenatal care visits, home visits), at birth, and postpartum (up to 6 months later).

The MCH Evidence Center research team tried to categorize studies by the intervention type—individual level (psychosocial or pharmacological) or population-based—and then the main strategy used. It is important to note that a number of interventions were multi-component (two or more) and it was difficult, at times, to parse them apart or identify the main strategy being studied. These strategies are summarized by their intervention components or as multicomponent interventions. It is also important to know that pharmacotherapies were often offered as part of a tailored intervention where women were offered higher levels of psychosocial support. Only one study was included that specifically focused on a pharmacological intervention (NRT). The included studies (n=42) are summarized below by intervention type and then specific strategy.

Individual level interventions. Overall, there is convincing evidence that behavioral interventions can aid in tobacco cessation without causing harm (Haddad & Davis, 2016). Pharmacotherapy with NRT has potential risk to both the women and the baby, but data are lacking as to whether those risks are greater or less than the risks of continued tobacco use (Haddad & Davis, 2016). No studies have explicitly evaluated the risk of benefit of bupropion and varenicline in pregnant women. Of the 42 included studies in this evidence review, 37 studies focused on individual level interventions (psychosocial and pharmacological) and their effect on smoking cessation during pregnancy.87

86 Many studies did not specifically specify what constituted usual practice or standard care received by the comparison/control groups. If an approach, such as 5 A’s, was described, then that was noted. 87 Studies could be counted in more than one intervention category (e.g., counseling + health education); therefore, the counts (n) for each of the intervention components does not equal 42.

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Under psychosocial interventions, the wide array of clinical and community-based intervention strategies includes counseling, health education, incentives, social support, structured support for physical activity, feedback, and other:88

1. Counseling (n=12) interventions are those which provide motivation to quit, support to increase problem solving and coping skills, and may incorporate “transtheoretical” models of change. This includes interventions such as motivational interviewing, cognitive behavior therapy, psychotherapy, relaxation, problem solving facilitation, and other strategies.

2. Incentives (n=10) include those interventions where women receive a financial incentive, contingent on their smoking cessation; these incentives may be gift vouchers, cash, or other products. Interventions that provided a “chance” of incentive (e.g. lottery tickets, prize draws) combined with counseling were coded as “counseling” in this review, and subgroup analysis of trials incorporating use of lottery tickets were reported.

3. Health education (n=5) interventions are defined as those where women are provided with information about the risks of smoking and advice to quit, but are not given further support or advice about how to make this change. Interventions where the woman was provided with automated support, such as self-help manuals or automated text messaging, but there was no personal interaction at all, were categorized as health education in this review.

4. Exercise (n=3) interventions are those where structured support for physical activity, such as treadmill walking, is provided with the specific aim of promoting smoking cessation in pregnancy.

5. Feedback (n=2) interventions are those where the mother is provided with feedback and information about the fetal health status or measurement of by-products of tobacco smoking to the mother. This includes interventions such as ultrasound monitoring and CO or cotinine89 measurements, with results shared with the mother.

6. Social support (peer, professional and/or partner) (n=2) interventions include the provision of support from a peer (including self-nominated peers, “lay” peers trained by project staff, or support from healthcare professionals) or from partners, as a strategy to promote smoking cessation.

7. Other (n=6) strategies that did not fit into the categories listed above (e.g., automatic initiation of smoking cessation program, journaling, health care provider training), including dissemination interventions (where both intervention and control group received the same intervention, but the dissemination strategy differed).

Many of studies tested novel approaches to existing interventions by attempting to reach women using electronic means, either by telephone, electronic mobile phone application, or a website as seen in both the counseling and health education categories. The others used interventions embedded into health or home visiting programs to reach pregnant women smokers at existing 88 These categories were originally used in the Chamberlain et al. (2017) systematic review. 89 Cotinine is a product formed after the chemical nicotine enters the body. Measuring cotinine in people’s blood is the most reliable way to determine exposure to nicotine for both smokers and nonsmokers. Measuring cotinine is preferred to measuring nicotine because cotinine remains in the body longer. Cotinine can be measured in hair, saliva, and urine (https://www.cdc.gov/biomonitoring/Cotinine_FactSheet.html).

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touch points in their health care. The incentive strategies were monetary or vouchers for retail purchases based on smoking abstinence rates (either verified or self-reported) at specific points of care, often as an enhancement to a standard smoking cessation package (e.g., 5 A’s).

Two (n=2) studies reported on multicomponent interventions that could not be parsed apart. One used two multicomponent standard pregnancy smoking cessation packages, ACOG 5A’s and the Smoking Cessation and Reduction in Pregnancy Treatment Method (SCRIPT) methods embedded into four different home visiting programs (Nurse Family Partnership, Parents as Teachers, Healthy Families America, and Early Head Start). The other trained Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) site staff to use the ACOG 5A’s smoking cessation in pregnancy package and compared the smoking rates of the women from the trained sites to the untrained.

Pharmacological treatments for smoking in pregnancy can include NRT, varenicline, bupropion, and ENDS. Apart from NRT, pharmacological therapies are not generally used to promote smoking cessation in pregnancy. Bupropion and varenicline are effective methods for non-pregnant smokers, but there is no strong evidence that either major positive or negative outcomes were associated with gestational use of bupropion or varenicline (Turner et al., 2018). The pharmacotherapy study included in this review looked at the use of NRT (n=1) for cessation in pregnancy. Other medications, such as bupropion and varenicline, were offered as part of an array of treatment options when providers utilized the 5 A’s of smoking cessation. However, there were no recent trials in the included studies that specifically focused on bupropion, varenicline, or ENDS and whether they assisted with maternal smoking cessation.

Population-based interventions. Non-clinical, public policy-related interventions can include governmental and tobacco control policies, such as smoke-free legislation or smoking bans, tobacco taxation, product packaging and regulation, advertising/marketing restrictions, media campaigns, and healthcare financing systems for increasing use of tobacco dependence treatment. Five (n=5) studies reported on the effects of smoke-free policies on pregnant women, including the influence of smoking bans, national smoking cessation media campaigns, state and local smoke-free policies, and the impact of having access to health care coverage on smoking cessation in pregnancy.

Data Sources and OutcomesData sources and study results are presented in Table 5: Data Sources, Outcome Measures, and Study Results. Data sources included surveys, biochemical verification (salivary or urine cotinine levels, breath CO), health or birth records, telephone or in-person interviews, website or mobile application statistics, and standard depression or nicotine dependence scales. Most (28 studies or 66%) of the included studies used more than one data source. Seventeen used a combination of surveys and biochemical verification to determine smoking rates or cessation from interventions, 3 used telephone surveys with biochemical verification, 3 used standard scales and biochemical verification, 3 used telephone or electronic usage statistics with records

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review, and 2 used record review and biochemical verification. Fourteen of the studies used a single data source, such as records review (10), telephone or electronic usage statistics (3), or surveys alone (1).

The outcome measures across the studies included feasibility or acceptability of interventions, smoking cessation or abstinence rates, smoking reduction rates, rates of receiving the intervention, costs, maternal health, birth outcomes, standard scale indicators (nicotine dependence, depression), and rate of participation in interventions. Most of the studies (35 or 83%) reported using a combination of these outcome measures.

The study results varied from no effect through favorable trends for change in smoking behaviors to statistically significant reduction in cigarette use or increased rates of smoking cessation. Most of the studies reported results for more than one indicator (acceptability, participation, smoking cessation). Nine (21%) of the studies reported the interventions were feasible or acceptable to participants. Twelve (28%) of the studies reported statistically significant smoking cessation behaviors and 3 found significant increases in referral or participation in smoking cessation care. Fourteen (33%) reported that while not statistically significant, positive trends in reducing or abstaining from smoking and 3 found positive trends in participation in interventions to stop smoking. Seventeen studies found no change in the smoking behaviors or abstinence rates after intervention.

LimitationsTable 6: Limitations describes the limitations reported for each study. The studies all reported more than one limitation in interpreting the results. Sixteen of the studies had small sample sizes or issues with power to detect significant changes with 8 studies indicating their sampling from a limited geographic area made generalizations of findings difficult. Variability of data or lack of fidelity implementing interventions was a limitation in 12 of the studies. Difficulty with recruiting and maintaining participants or loss to follow up was cited by 11 of the studies. Reliance on self-reporting without biochemical verification was a limitation for 8 of the studies. Lack of a control group, non-randomization, or another control group issue was cited by 8 studies.

Evidence Rating and Evidence ContinuumThe assignment of evidence ratings was based on study design and the results described within each individual study. We think a study can be judged on its own merit with regard to the evidence it is contributing to the smoking cessation during pregnancy research portfolio. Table 7: Individual Evidence Ratings lists the studies selected for inclusion, indicates which intervention type/components comprise the intervention design, and provides the evidence rating. The table is arranged from the scientifically rigorous (most favorable) to evidence against (least favorable) evidence ratings.

The table below summarizes the evidence-based and evidence-informed strategies to decrease the number of women who smoke during pregnancy by setting, intervention type, strategy,

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and evidence rating. 90 The target audience for the interventions is pregnant women with one exception—the health care provider training is focused on health care practitioners. Figure 2: Evidence Continuum visually displays the intervention types and configurations along the evidence continuum from evidence against (least favorable) to scientifically rigorous (most favorable) by setting.

Summary of Evidence-Based and Evidence-Informed Strategies to Decrease the Number of Women Who Smoke During Pregnancy



Clinic-based Incentive Financial incentives and vouchers to enhance smoking abstinence in a multicomponent standard smoking cessation package for pregnant women (n=7) (Lopez, 2015a; Lopez, 2015b; Olson, 2019; Passey, 2018; Tappin, 2015; Wen, 2019; Zvorsky, 2015)

Moderate evidence

Counseling Enhanced adult smoking cessation program with motivational interviewing targeting pregnant women (n=6) (Bailey 2015; Fallin-Bennet, 2019; Lee, 2015; Naughton, 2017; Patten, 2019; Reynolds, 2019)

Moderate evidence


Multicomponent standard smoking cessation package for pregnant women embedded into Women, Infants, and Children (WIC) prenatal care clinic services (n=1) (Olaiya, 2015)

Moderate evidence

Pharmacotherapy NRT + multicomponent standard smoking cessation package for pregnant women (n=1) (Berlin 2014)

Moderate evidence

Health care provider training

Health care provider training including maternity staff, administrators and smoking cessation counselors; or midwives (n=2) (Bell 2018; Chertok, 2015)


Automatic initiation of smoking cessation program

Biochemical verification or electronic health records used to automatically opt in pregnant smokers to smoking cessation program (n=3) (Bailey 2017; Buchanan, 2017; Campbell, 2017)

Emerging evidence

Feedback Indoor air quality measurement feedback + multicomponent standard smoking cessation package for pregnant women (n=1) (Morgan, 2016)

Emerging evidence

Exercise Exercise + multicomponent standard smoking cessation package for pregnant women (n=3) (Jin, 2018; Ussher, 2015a; Ussher, 2015b)

Evidence against

Electronic Health education Standard motivational text messages added to support standard multicomponent smoking cessation program for pregnant women (n=1) (Forinash, 2018)

Moderate evidence

Health education + Incentives

Standard smoking cessation text messages specific to pregnant women + monetary incentives/gift vouchers to complete follow up at 1, 3 and 6 months (n=2) (Abroms 2017a; Abroms 2017b)


Health education + Social support

Standard smoking cessation text messages with limited interaction for support to pregnant women + social support for quitting via a “quitpal” (n=1) (Abroms 2015)

Emerging evidence

Counseling Telephone, internet platform or text application to deliver individual counseling support for smoking cessation (n=4) (Coleman-Cowger, 2018; Cummins, 2016; Sloan 2017; Stiegler, 2016)

Emerging evidence

Counseling + Incentives + Feedback

Web-based, incentive-based contingency management program + phone-delivered cessation counseling + feedback based on breath CO results (n=1) (Harris, 2015)

Emerging evidence

Journaling Online journaling platform to support smoking cessation for pregnant women (n=1) (Minian, 2016)

Emerging evidence

90 The strategies are arranged by setting and the strength of the evidence ratings from most to least favorable.

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Community-based


Home visitors use smoking cessation strategies (education, motivational interviewing, referral to smoking cessation resources) during home visiting program visits (n=1) (Griffis, 2016)

Moderate evidence

Counseling Trained midwives to provide smoking cessation counseling with standard smoking cessation package to pregnant women and household members in home-based care (n=1) (Eddy, 2015)

Emerging evidence

Social support Using voluntary community members as community support workers to deliver in-person, culturally appropriate multicomponent smoking cessation package to pregnant women (n=1) (Glover, 2016)

Emerging evidence

Population-based

Policy National, state or local anti-smoking campaigns or regulations to increase smoke-free environments (n=5) (Bartholomew 2016; Brown, 2016; England, 2017; Hankins, 2016; Havard, 2018)

Mixed evidence

Key FindingsOverall, 6 key findings emerged from the analysis:1. In terms of setting, of the 42 studies:

a. 24 studies (57%) were clinic-based interventions (e.g., obstetrical/prenatal/primary care clinics, community health centers, hospital delivery units),

b. 3 studies (7%) were community-based interventions (e.g., home/residential health care, community-based home visiting organizations),

c. 10 (24%) of the studies were conducted electronically (e.g., phone applications, telephone, online), and

d. 5 (12%) were policy interventions to increase smoke-free environments.2. Psychosocial interventions tested are predominately focused on enhancing standard

multicomponent smoking cessation programs for pregnant women.a. The standard package generally consisted of the 5 A’s of smoking cessation (Ask, Advise,

Assess, Assist, and Arrange) or a variation of this approach under the guidance of trained practitioners to help women quit smoking or maintain smoking cessation during and after pregnancy.

b. This clinic-based (or office-based) intervention that systematically identifies pregnant women who smoke and offers treatment or referral has been proven to increase quit rates.

c. Studies primarily used clinical settings to build in additional intervention components to support smoking cessation for pregnant women.

3. Psychosocial interventions that encourage behavior change and support smoking cessation consist of counseling, incentives, health education, exercise, feedback, and social support. Psychosocial interventions were delivered in clinic-based, electronic, and community-based settings.a. Counseling and incentives were the most frequently used and effective standalone

interventions. There is moderate evidence for both of these intervention types. Chamberlain et al. (2017) found that counseling, incentives, and feedback appeared

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to be effective in reducing the number of women who smoke late in pregnancy; the provision of health education and risk advice alone is not sufficient.

b. Different combinations of intervention components are used to enhance the effectiveness of smoking cessation for pregnant women. Intervention components were most often combined when programs were delivered electronically. There is primarily emerging evidence for the different configurations of intervention components (e.g., counseling + health education; counseling + feedback + incentives; health education + incentives; health education + social support). Given the limited number of studies on these combinations of components, further research is needed to determine effectiveness.

c. Embedding multicomponent psychosocial programs into community-based programs, such as home visiting, or social support programs, such as WIC, have moderate evidence of effectiveness to increase smoking cessation in the pregnant women they serve.

4. Researchers are attempting to use novel ways of delivering psychosocial interventions to increase the reach and effectiveness of smoking cessation programs in pregnancy, such as technology or culturally acceptable practices.a. Both general and individualized mobile phone applications have been attempted with

some positive trends.b. Individualized phone counseling is used to support behavior change and smoking cessation.c. Internet-based/website education, incentives, and feedback and support are being

increasingly utilized for smoking cessation during pregnancy.d. Community health workers or a culturally acceptable equivalent is being used to reach

indigenous or isolated communities of pregnant women with high smoking rates.5. Pharmacological interventions for smoking in pregnancy can include NRT, varenicline,

bupropion, and ENDS. However, their efficacy and safety in pregnancy remains unknown.a. Pharmacotherapies were oftentimes included as part of tailored interventions where

pregnant women were offered higher levels of psychosocial support, referrals, and a menu of cessation aids.

b. There was 1 pharmacotherapy study included in this review on the use of NRT that was rated as moderate evidence. Results from Coleman et al. (2015) indicate that NRT used for smoking cessation increased rates measured in late pregnancy by approximately 40%. However, there is evidence suggesting that when potentially-biased, non-placebo trials are excluded from the analyses, NRT is no more effective than placebo.

6. Population-based interventions consist of non-clinical, public policy-related efforts, such as smoke-free legislation or smoking bans, tobacco taxation, product regulation, advertising/marketing restrictions, and media campaigns. For the 5 studies in this evidence review focused on population-based messaging, campaigns, smoke-free policies, and access to health coverage, there was mixed evidence of effectiveness in specifically supporting pregnant women to become smoke-free.

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DISCUSSION AND IMPLICATIONSThis section discusses data trends, examples of effective interventions, and a summary of study insights. This section also highlights important considerations in working with pregnant women and designing effective interventions to encourage and support quit efforts during pregnancy.

The purpose of this review was to provide information about evidence-based and evidence-informed interventions to decrease the percent of women who smoke during pregnancy. The MCH Evidence Center identified interventions focused on smoking cessation for pregnant women to diminish the adverse health risks for mothers and fetuses.

Data TrendsWith overwhelming evidence that smoking cessation by pregnant women benefits their health and that of their fetuses and newborns (USDHHS, 2020), there has been a steady decline in the number of women who smoke during pregnancy. Though it is estimated that 7.2% of women smoked cigarettes during pregnancy in 2016,91 the strong social norms discouraging smoking among pregnant women may lead some women to withhold disclosure of their true smoking status. Screening that considers the stigma associated with smoking in pregnancy and provides supportive guidance and easily accessible resources is crucial. The 5 A’s method for brief interventions has substantial research support for its utility to help tobacco users, including pregnant women, quit smoking and maintain smoking cessation (ACOG, 2011). Accumulating evidence from systematic reviews and a review of the most recent literature reveals that psychosocial interventions, such as counseling and incentives, particularly as enhancements to a standard smoking cessation package, can be quite effective to help pregnant women quit smoking.

Short counseling sessions with pregnancy-specific health educational materials and referrals to a quit line have been demonstrated to be an effective smoking cessation strategy. In addition, evidence from recent studies conducted in the U.S., Australia, and the U.K. build on earlier findings that support both the efficacy and cost-effectiveness of contingency-based financial incentives as a smoking deterrent. Not only are such incentives effective in reducing the number of pregnant women who smoke, but the cost—in terms of cotinine-validated quitters, quality-adjusted life years, and direct costs—is similar to standard care for smoking-cessation (Boyd et al., 2015). With concerns around the safety and efficacy of pharmacotherapies for pregnant women, the vast majority of interventions are psychosocial in nature. Other psychosocial interventions with a growing evidence base include health education, social support, feedback, and automatic initiation of a smoking cessation program. With multicomponent psychosocial interventions showing value, further research is needed to determine the effectiveness of different intervention configurations.




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There was evidence against exercise interventions that provided structured support for physical activity. These interventions consisted of physical activity consultations, supervised treadmill walking, and behavioral cessation support sessions, or moderate physical activity (unspecified) and individualized cognitive behavioral counseling based on the 5 A’s. These interventions may have been ineffective due to the short duration and/or insufficient dosage. It seems that supplementing behavioral support with a physical activity is no more effective than behavioral support alone in promoting smoking cessation during pregnancy. Lastly, although population-based interventions such as smoking bans and media campaigns help promote a cultural norm toward smoke-free environments, the evidence is mixed with regard to increasing quit rates specifically for pregnant women. One study with moderate evidence reported that exposure to a national anti-smoking campaign for a general audience was associated with smoking cessation in pregnant women; further research may be warranted to determine the effects of mass media campaigns and other policy interventions.

Highlights of Effective Intervention StudiesBelow are studies that showed positive results and illustrate some of the intervention strategies being tested to support smoking cessation during pregnancy. Each example of an effective intervention (rated as scientifically rigorous or moderate evidence) describes the study design, intervention component(s), and positive results.

#1: Example of an evidence-based smoking cessation in pregnancy intervention using counseling

Naughton (2017) examined the effectiveness of a 12-week advice and pregnancy smoking cessation support program delivered by short message service (SMS) text message. Tailoring characteristics for MiQuit included gestation, motivation to quit, the hardest situation to avoid smoking, cessation self-efficacy, cigarette dependence, and partner’s smoking status. “Push” support (automated support sent to participants’ phones) was delivered according to a delivery schedule (0, 1, or 2 daily texts). Push message frequency

was highest in the first 4 weeks. Push support included motivational messages, advice about quit attempt preparation, managing cravings and withdrawal, dealing with trigger situations

and preventing lapses, and information about fetal development and the effects of smoking.

Results: Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (4 of 204) of usual care participants. There is evidence that an individualized, automated, and interactive text-messaging program may increase cessation rates in pregnant smokers when provided alongside routine smoking cessation care.

#2: Example of an evidence-based smoking cessation in pregnancy intervention using an incentive

Tappin (2015) assessed the efficacy of a financial incentive added to routine specialist pregnancy “stop smoking services” versus routine care to help pregnant smokers quit. The



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control group received routine care, which was the offer of a face-to-face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free NRT for 10 weeks provided by pharmacy services, and 4 weekly support phone calls. The intervention group received routine care plus the offer of shopping vouchers (a financial incentive for attending a face-to-face appointment and setting a quit date; another incentive if at 4 weeks’ post-quit date with exhaled CO confirmed quitting required; a further incentive for continued validated abstinence of exhaled CO after 12 weeks; and a final voucher for validated abstinence of exhaled CO at 34-38 weeks’ gestation).

Results: Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) P<0.001. This trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy.

#3: Example of an evidence-based multicomponent psychosocial intervention to support smoking cessation in pregnancy

Griffis (2016) explored the effect of home visiting on perinatal smoking. Home visitors in the Nurse Family Partnership, Parents as Teachers, Healthy Families America, and Early Head Start home visiting program supported attempts by pregnant women to reduce and quit smoking using the 5 A’s prenatal smoking cessation approach and the Smoking Cessation and Reduction in Pregnancy Treatment Method (SCRIPT) that use various smoking cessation intervention strategies, including client education of smoking harms and cessation strategies, motivational interviewing, and referral to outside programs that offer smoking cessation counseling.

Results: A program effect was seen for smoking cessation among light (less than 10 cigarettes during the first trimester) and heavy (20 or more cigarettes during the first trimester) baseline smoking clients. Clients who were light baseline smokers had a 45% probability of smoking cessation compared to 38% for comparison women. Heavier baseline smoking clients also had a higher probability of smoking cessation—16% compared to 12%. As home visiting programs continue to expand, it will be important to identify effective ways to support tobacco-related harm reduction with pregnant women and vulnerable families.

#4: Example of an evidence-based health care provider training to support smoking cessation in pregnancy

Bell (2018) tested the effectiveness of a complex intervention to improve referral and treatment of pregnant smokers in routine practice. A package of measures was implemented in hospitals and smoking cessation services, aimed at increasing the proportion of pregnant smokers quitting during pregnancy, comprised of skills training for healthcare and smoking cessation staff; universal CO monitoring with routine opt-out referral for smoking cessation support; the provision of CO monitors and supporting materials; and an explicit referral pathway and follow-up protocol.



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Results: Referrals to smoking cessation increased by 2.5 times and the proportion of women quitting by delivery by nearly twofold. Quitting smoking during pregnancy was associated with a clinically important increase in birth weight. The referral rate increased progressively in the first 3 months after the intervention was introduced. The intervention was associated with a significant increase in referrals. Additional training sessions were associated with an increase in referrals in the month of, as was availability of a system for enhanced initial contact with smokers. Introduction of the intervention was associated with a significant increase in quitting by delivery. The odds of quitting were higher for deliveries with a recorded referral to smoking cessation services, and if there was a record of a quit date. The odds of quitting were significantly higher following additional training.

Implications for PracticeThe research being conducted to decrease the number of women who smoke during pregnancy provides valuable insights that can inform current Title V program initiatives and partnerships to improve the health and well-being of mothers and children. The major takeaways below can inform program design and implementation efforts to provide greater support for smoking cessation in pregnancy.

1. Considerations for vulnerable populationsSocioeconomic and demographic factors. Unemployed women with little education are more likely to smoke during pregnancy compared to their employed, higher income, more educated counterparts. Research findings indicate that chronic stressors, symptoms of depression, and the quality of intimate relationships play an important role on the pathway to smoking cessation (Yang et al., 2017). Other factors associated with smoking during pregnancy include social support, neighborhood risk, access to prenatal care, alcohol or illicit drug abuse, SHS exposure, and abuse/trauma (Yang & Hall, 2019). Women who experience intimate partner abuse before or during pregnancy are more likely to smoke (Alhusen et al., 2018), and high rates of maternal smoking in the neighborhood can increase individual smoking risk (Chesnokova et al., 2015). At the same time, positive neighborhood influences, including culturally-sensitive interventions that target specific residential enclaves, can result in positive outcomes (Noah et al., 2015).

The evidence also shows a strong correlation between romantic partner influences during the prenatal and postpartum periods—particularly the influence of young male fathers/fathers-to-be on their pregnant partners (Desrosiers et al., 2016). Couples-based interventions that target young male partners who use tobacco, alcohol, or other drugs, particularly cigarettes and/or marijuana, may be effective in reducing maternal smoking if they target substance use among male partners during the prenatal period (Desrosiers et al., 2016). The prenatal period may represent a critical window during which reducing substance use among fathers has a strong impact on preventing initiation or relapse among mothers in postnatal periods. However, some partner and/or peer-support behaviors may be unhelpful, and may potentially expose vulnerable women to increased risk (Chamberlain et al., 2017).



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Pregnant women from socioeconomically-disadvantaged backgrounds are likely to benefit from targeted cessation interventions delivered by trained health care providers (Siddiqui et al., 2017). One such program, the Tennessee Intervention for Pregnant Smokers (TIPS program), combined the 5 A’s model with educational materials and motivational interviewing by trained health educators. Targeting a rural, Southern population with high rates of smoking, the intervention resulted in a 28.1% quit rate among study participants, compared with a 9.8% quit rate in the control group that received standard care only (Bailey, 2015).

Another promising intervention, Smoke-Free Moms, combined the 5 A’s delivered by clinic staff in a prenatal care setting with a financial incentive for low-income, rural women who are pregnant. Although the quit rates were the same among the study participants and the control group (all of whom received the 5 A’s), those who were also given a gift card upon confirmed negative urinary cotinine during visits were more likely to remain smoke-free postpartum (Olson et al., 2019). The 5 A’s model also proved effective with pregnant clients of the Special Supplemental Nutrition Program for WIC clinics in Ohio. The intervention included WIC staff training in 38 separate clinics on how to deliver the 5 A’s. The researchers found that the odds of self-reported smoking cessation among pregnant women attending Ohio WIC clinics were higher after the clinic staff (most of whom were not physicians) had received 5 A’s training (Olaiya et al., 2015).

Mental health variables (depression, mood disorders, and addictive behaviors). Psychosocial variables, such as chronic stressors, depressive symptoms, and quality of intimate relations, are linked to prenatal smoking—particularly in lower socioeconomic groups of pregnant women (Yang et al., 2017). Cigarette smoking is highly associated with depression and other mood disorders in the general population and is also an important risk factor for postpartum depression (Lopez et al., 2015). Numerous studies have examined these variables in search of interventions that will effectively address the factors that contribute to smoking likelihood in pregnant women. Given the high co-morbidity with psychological symptoms and the potential to improve psychological well-being, interventions that include psychological support for women with symptoms should be considered (Chamberlain et al., 2017).

Depression-prone pregnant women and newly postpartum women have responded well to incentive-based smoking cessation interventions, where participants not only achieved abstinence, but also reported a reduction in the severity of their depression. Women who earned vouchers exchangeable for retail items—contingent on abstaining from smoking—were more likely to abstain from smoking than a control group of pregnant women who received non-contingent rewards. In addition, the intervention decreased postpartum Beck Depression Inventory ratings, compared with the control treatment (Lopez et al., 2015; Zvorsky et al., 2015).

Incentive-based treatment (contingency management) has also proven to be effective in pregnant women who not only smoke tobacco but also use licit or illicit substances, such as alcohol, marijuana, or opioids. However, despite the high prevalence and adverse consequences of



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smoking in pregnant women in medication-assisted treatment for an opioid use disorder, few studies have evaluated smoking cessation interventions targeting this population. Among those, only incentive-based interventions resulted in significant increases in smoking abstinence and reduction among pregnant women (Akerman et al., 2015). Based on the principle of conditioning that rewards biochemically-validated behavior, incentive-based interventions have consistently shown to decrease the use of alcohol and increase rates of smoking cessation. Pregnant women are a vulnerable population with much to gain from effective interventions for substance use disorders, and for whom incentive-based interventions appear to be especially well-suited (Hand et al., 2017).

Indigenous populations. Although tobacco smoking during pregnancy has continued to decline in high-income countries, the rate of smoking among indigenous women remains high. According to the most recent data from the CDC, 7.2% of women who give birth in the U.S. smoked during pregnancy (Drake et al., 2018),92 and yet the rate is much higher among pregnant Native Americans and Alaska Natives (approximately 26%) (Gould et al., 2017). Contributing factors include social norms within indigenous communities, few nonsmoking role models, insufficient knowledge of smoking harm, late presentation to care, and poor access to culturally-appropriate tobacco cessation support (Gould et al., 2017).

To date, few trials on smoking cessation interventions for indigenous women have been completed, and those involving biomarker feedback (Patten et al., 2019) or intense counseling combined with NRT were inconclusive (Patten et al., 2019). However, there is a growing body of evidence indicating that contingency-based incentives that reward biochemically-confirmed smoking cessation—combined with standard care that includes counseling—can be very effective, whether in the form of gift cards, vouchers for baby products, cash incentives, or redeemable “self-deposits” or self-incentives (Notley et al., 2019).

Culturally-sensitive feasibility studies that included smoking cessation incentives for indigenous women in New Zealand and Australia are encouraging (Glover et al., 2015; Passey et al., 2018), particularly when combined with a comprehensive approach that takes place at the state or national level (Chamberlain et al., 2017). However, a feasibility study that combined cessation counseling with a social-cognitive feedback intervention for reducing smoking among Alaska Native pregnant women did not result in increased cessation rates (compared to usual care) (Patten et al., 2019). Therefore, more research into smoking-cessation interventions that specifically target indigenous American women would be useful.

2. Training for women’s health care providersAlthough research indicates that smoking cessation interventions are most effective when delivered by trained health care staff, many health practitioners do not receive training in how to deliver the 5 A’s or other evidence-based smoking cessation interventions. In a recent survey of 275 Obstetrics-Gynecology Residency Directors in the U.S., 60% of respondents said that




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they did not have a formal, structured curriculum on smoking cessation/tobacco products (Nims et al., 2019). And, in an early survey of obstetrician-gynecologists, 4 out of 5 respondents were unaware of the Affordable Care Act provision that required states to provide tobacco cessation coverage for pregnant women (Tong et al., 2015).

Midwives are also in a position to offer counseling and support to pregnant patients who smoke. In a national survey of smoking cessation education within the U.K. Midwifery School curricula, all of the 29 schools that responded (55% of those surveyed) reported teaching the harmful effects of tobacco use (Forman et al., 2017). However, despite the strong support for training in smoking cessation counseling within the International Confederation of Midwives (Fullerton et al., 2018), the October 2019 update of Competencies for Midwifery Practice do not specifically mention smoking cessation interventions.93 However, in the Netherlands, the Dutch Health Care Inspectorate (a government body that supervises health care providers in efforts to ensure quality) recently assessed and promoted a guideline on smoking cessation counseling in midwifery practice. A follow-up study then investigated factors that might optimize adherence to the guideline (Oude Wesselink et al., 2017).

In Australia, similar efforts are underway to improve implementation of national smoking cessation guidelines. In a study focusing on barriers to guideline implementation, the 27 obstetricians, midwives, and maternity service managers who participated concluded that key obstacles include lack of knowledge, skills and training; perceived time restrictions; avoidance of difficult conversations; perceiving smoking as a social activity; and systems which did not support implementation or monitoring (Longman et al., 2018). Other studies also concluded that there are opportunities to improve clinical support for pregnant smokers at the organizational, inter-service, and healthcare professional levels (Naughton et al., 2018). Deficits in knowledge and confidence, perceived lack of time, and concerns about damaging client relationships were among the barriers cited (Naughton et al., 2018).

In a synthesis of qualitative research on health professionals’ perceptions of the barriers and facilitators to providing smoking cessation advice to pregnant and postpartum women, the need for professional education stood out, including both pre-qualification and continuing professional development that will enable individuals to provide smoking cessation support to pregnant women. Key to the success is recognizing the importance of the provider/patient relationship and the barriers associated with helping women in disadvantaged circumstances give up smoking. The authors conclude that improving the quality and accessibility of evidence on effective healthcare interventions, including evidence on “what works” to support smoking cessation in disadvantaged groups, should therefore be a priority (Flemming et al., 2016).

“What works” is likely to be a multi-faceted approach that considers the role that health care providers at all levels might play in reducing the number of pregnant women who smoke. Dental teams, nursing practitioners, prenatal-care administrators, and WIC program staff can make a

93 https://www.internationalmidwives.org/assets/files/general-files/2019/11/poster-icm-competencies-en-screens--final-oct-2019.pdf



56

difference in efforts to reduce the numbers of pregnant and postpartum women who smoke. With studies suggesting that women resume smoking after pregnancy, it is important for practitioners to repeatedly reinforce the benefits of staying quit for the mother, rather than solely focusing on the benefits for the infants (Chamberlain et al., 2017).

3. Importance of smoking cessation timingThe “timing “of smoking cessation during pregnancy is important to the developing fetus, with possible smoking-influenced epigenetic processes taking place as early as the embryonic stage of development and lasting through the second month of pregnancy. There is also evidence that the increased risk of smoking-influenced low birth weight dissipates when expectant mothers quit smoking by the fifth month (Alshaarawy & Anthony, 2015). Low birth weight puts newborns at an increased risk for negative health outcomes—many lasting throughout the life course.

Data collected from the National Surveys on Drug Use and Health Restricted-Data Analysis System (R-DAS) (2002-2009) indicates that of the approximately 27% of women who reported smoking during the first month of pregnancy, only about 17% continued to smoke by the third month. At month five, approximately 15% of survey respondents reported smoking, and that number dropped to about 11% by the ninth month. These numbers reflect the fact that many smokers quit after learning they are pregnant—the pregnancy itself having an ameliorative effect—and they suggest a missed opportunity for earlier pregnancy diagnosis, which could increase smoking cessation rates. In addition, the risk of low birth weight can be reduced, if not eliminated, when pregnant women are able to quit smoking by their fifth month of pregnancy. Cessation during any stage of pregnancy, however, is likely to improve health outcomes for both mother and child.

4. Use of cotinine and carbon monoxide testingNumerous studies have focused on point-of-care testing for cotinine (an indicator of nicotine presence), which can be found in urine, blood, saliva, and hair samples. CO breath testing can also be used to confirm tobacco smoking. While some studies have focused on the reliability/data validity of self-reported smoking status (comparing those to a CO analyzer or cotinine lab results), others have looked at the effect, whether positive or negative, that the testing itself has had on pregnant women. Emerging evidence indicates that women who admit to smoking and “opt in” to such testing may be more receptive to subsequent smoking recommendations and referrals, and health care providers may find it easier to discuss smoking cessation measures with women who consent to disclose their smoking status (Mentor et al., 2016; Westcott & Navidad, 2018). However, policies that call for the routine testing of all pregnant women could unintentionally do more harm than good, since it can send the message that pregnant women cannot be trusted and may not make decisions in the best interests of themselves and their unborn offspring. If the goal is to improve maternal and child health outcomes, the evidence leans towards encouraging, supporting, and empowering pregnant women to “opt in” to effective interventions (Bowden, 2019).



57

5. Use of digital interventionsSmoking cessation interventions that use digital forms of communication, whether it be social media, text messaging, web interfacing, or smart phone applications, have the potential to reach large numbers of women of reproductive age. Data collected by the PEW Research Center shows a dramatic increase in cell phone ownership in recent years (currently 96% of all Americans), and smartphone ownership is up from 35% in 2011 to 81% in 2019.94 The majority of pregnant women (approximately 70%) routinely use a smartphone for personal reasons, according to the Population Assessment of Tobacco and Health (PATH) study, a collaboration between the U.S. FDA, NIH, and the National Institute on Drug Abuse (NIDA).

Although results from RCTs vary, a systematic review and meta-analysis of digital interventions conducted in 2018 indicates that text messaging and computer-based technology are most likely to reduce the numbers of pregnant women who smoke (Griffiths et al., 2018). However, the effectiveness of the intervention not only varies according to participants’ demographic and socioeconomic factors, but also on the messaging itself. Digital interventions using embedded behavior change techniques that focus on setting goals, solving problems, and planning next-steps may be more successful. Also, a higher number of behavior change techniques embedded in the digital intervention may improve the outcome (Griffiths et al., 2018).

While digital technology offers the potential to influence vast numbers of pregnant women who smoke, it is ultimately just a highway—an alternative delivery method—rather than a separate intervention type. And despite the prevalence of cell phone owners in the U.S., a digital divide persists between rich and poor, rural and urban/suburban. Roughly three in ten adults with annual household incomes below $30,000 do not own smartphones, and more than four in ten do not have a broadband internet service (44%) or a traditional computer (46%).95 Rural Americans are also less likely than urban or suburban adults to have home broadband, own a smartphone, or own multiple devices or services that enable them to go online. About three in ten adults who live in rural communities (31%) report that they own a desktop or laptop computer, a smartphone, a home broadband connection, and a tablet computer. By contrast, 43% of suburban adults own all four of these technologies.96 These statistics are important moving forward given that technology-based interventions are becoming increasingly prevalent. While they can be effective among those who have access to the technology, they will inevitably bypass a large number of less-advantaged pregnant smokers who reside on the opposite side of the digital divide.

6. Use of alternative and complementary interventionsGrowing evidence suggests that alternative and complementary interventions, such as massage therapy, meditation, journaling, and yoga instruction, might help reduce the number of pregnant smokers, particularly among women who have easier access to these alternate interventions.

94 https://www.pewresearch.org/internet/fact-sheet/mobile/95 https://www.pewresearch.org/fact-tank/2019/05/07/digital-divide-persists-even-as-lower-income-americans-make-gains-in-tech-adoption/96 https://www.pewresearch.org/fact-tank/2019/05/31/digital-gap-between-rural-and-nonrural-america-persists/



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According to the National Survey on Drug Use and Health and the National Health Interview Survey, anywhere from 6.9% to 29.1% of pregnant smokers are already using complementary and alternative medicine, particularly white women with a higher socioeconomic status (Loree et al., 2017). These findings suggest that a significant number of pregnant women who smoke are open to trying a variety of approaches to promote health. While further research is needed to guide safety and treatment recommendations, and to validate the effectiveness of alternative and complementary interventions for pregnant women, emerging evidence suggests that interventions such as massage therapy and journaling have the potential to help reduce stress and tobacco use among pregnant women (Minian, 2016; O’Hair et al., 2018).

7. Perception of Electronic Nicotine Delivery Systems as a safer alternativeThe use of e-cigarettes, vaping, and other forms of ENDS have increased significantly in recent years, but there is little data regarding the health effects of these agents on pregnant women.97 According to ACOG, there is the perception that these products represent a safer alternative to tobacco smoking, since combustion products are not present; however, nicotine in any form can pose considerable health risks to the developing fetus. ENDS are being used by both pregnant and non-pregnant smokers in the belief that it will help them quit or cut back on smoking. The evidence though does not support this widespread belief. A review of the literature on the use of electronic cigarettes in pregnancy (Whittington et al., 2018) indicates that anywhere from 0.06% to 15% of pregnant women use e-cigarettes, and the marketing of e-cigarette use as a “safer alternative” to tobacco smoking has contributed to a steady increase in these numbers. Many smokers mistakenly assume that e-cigarettes do not contain nicotine, although the nicotine consumed using e-cigarettes is similar to cigarettes, and the marketing of e-cigarettes as a “safer alternative” to tobacco smoking has contributed to a steady increase in e-cigarette use (Whittington et al., 2018).

Policy and Population-level InterventionsTobacco policies and population-level interventions have the potential to help reduce the number of pregnant women who smoke. However, the effectiveness of federal and state-wide policies and programs remains unclear, due in large part to the difficulty in determining causal relationships. Accumulating evidence indicates that tobacco control policies have a substantial impact on maternal and child-health outcomes (Levy et al., 2016), although few studies have specifically assessed the impact that government policies and interventions have on pregnant women.

Since pregnant women are often excluded from research studies due to safety and health-risk factors, much of the “evidence” is based on survey results, vital records, or simulations, where pregnant women are asked how they think they would respond to a specific intervention. For example, one low-risk study used a Cigarette Purchase Task to simulate changes in demand for hypothetical cigarettes as a function of varying cigarette prices (Hankins & Tarasenko, 2016; Higgin et al., 2017). Another policy-related study, based on two different data sets, concluded that stronger health warning labels that elicit stronger reactions (e.g., pictures) and increase 97 https://www.acog.org/-/media/Committee-Opinions/Committee-on-Obstetric-Practice/co721.pdf



59

knowledge of fetal harm is one action that could help reduce tobacco use among pregnant women (Mead et al., 2019). Innovative research approaches such as these appear promising in the ongoing effort to implement effective interventions that help reduce the number of pregnant women who smoke.

The Importance of Partnership and the Role of Title VPartnership is essential to effective implementation of smoking cessation interventions for pregnant women. Leaders in the field recognized the need to sustain the tremendous progress towards smoke-free pregnancies by creating a coordinated plan of action to close the remaining gaps in treatment and prevention of maternal smoking (Orleans et al., 2004). In 2002, the need for action led to the creation of the National Partnership to Help Pregnant Smokers Quit, a collaboration of more than 50 organizations and agencies, public and private, that joined forces to help pregnant smokers quit by providing effective clinical and community-based interventions to every smoker who is pregnant.98 This national partnership provided a model for how agencies and organizations can coalesce around a common cause—the prevention of maternal smoking—and promote a common agenda and set of strategies to more effectively help pregnant smokers quit. Today, cross-system collaboration remains pivotal to further reduce prenatal smoking. National experts, such as the CDC’s Office of Smoking and Health, ACOG, the U.S. Preventive Services Task Force, and the Robert Wood Johnson Foundation, are leading efforts to further reduce smoking during pregnancy. Title V programs are well positioned to coordinate and partner with these and other public and private agencies and organizations, especially state and territorial health agencies, state-funded quit lines, WIC, and state or local authorities responsible for the implementation and enforcement of tobacco control laws (e.g., state departments of health, county health departments, local health departments)99 to promote and provide widespread support for smoking cessation during pregnancy.

Notably, in 2013, the Association of State and Territorial Health Officials, with funding from the CDC, created an issue brief on smoking cessation strategies for women before, during, and after pregnancy.100 This resource can readily inform the work of Title V programs to engage in a coordinated health systems approach with partners to promote smoking cessation for pregnant women and mothers. These recommendations include: 1) Provide training and technical assistance to healthcare and public health providers on helping women quit using tobacco before, during, and after pregnancy; 2) Extend pregnancy-specific and postpartum-specific quit line services to women during and after pregnancy; 3) Promote awareness of cessation benefits and effectiveness of treatment by implementing coordinated media campaigns that specifically target women during childbearing years; 4) Develop customized programs for specific at-risk populations of women who are smokers and of reproductive age; 5) Include WIC sites as points for intervening with pregnant and postpartum women; 6) Design and promote barrier-free cessation coverage benefits for pregnant women in public and private health plans; 7) Promote

98 http://tobacco-cessation.org/sf/pdfs/pub/11)%20National%20Partnership%20Action%20Plan.pdf99 https://www.rand.org/content/dam/rand/pubs/monograph_reports/2006/MR841.pdf100 https://www.astho.org/Prevention/Tobacco/Smoking-Cessation-Pregnancy/

FROM EVIDENCE TO ACTION


60

cessation service integration aimed at improving birth outcomes; and 8) Implement evidence-based tobacco control policies that augment tobacco cessation for women before, during, and after pregnancy.101 Tobacco-free pregnancies require a multipronged approach supported at the community, state, and federal levels by a network of committed partners, including Title V programs.

FROM EVIDENCE TO ACTIONThe MCH Evidence Center developed this report as part of a series of scholarly works focused on each NPM to identify and describe evidence-based and informed strategies from peer-reviewed and grey literature. Interventions identified by this process form the cornerstone by which Title V agencies can construct programs and measures that will effect change with their unique populations and advance their NPM topic areas. As such, this is a first step in a long process for meeting National Outcome Measures (NOMs).

If you are looking to build or strengthen efforts to reduce smoking during pregnancy in your state or jurisdiction, moving “from evidence to action” can seem daunting. The MCH Evidence Center has developed the following framework, tips, and resources to help you through the process. We have developed resources and provide technical assistance for you at every step of this process:

1. Evaluate the evidence to guide your work. Aligning programs and measures with the evidence base helps to ensure programs meet the needs of infants, children, youth, and their families and have the most potential to effect change. We invite you to read through this report to understand the way each intervention identified root causes that were preventing change, produced a new, desired behavior change, and engaged partners and resources that yielded measurable effects.

You can also access additional evidence resources through our NPM 14: Smoking Toolkit (https://www.mchevidence.org/tools/npm/14-smoking.php) including:• A summary of the evidence identified by this report.• Promising practices as identified by the Association of Maternal and Child Health Programs

(AMCHP) Innovation Station.102

• Current ESMs used by other states and jurisdictions to use as examples.• Examples of ESMs that include links back to the evidence and show ways to measure effect.

In developing programs based on the available evidence, a critical factor is to ensure that identified interventions are applicable and adaptable to your population needs. The MCH Evidence Center utilizes Harvard University’s Science-Based Intervention Framework to ensure

101 https://www.astho.org/Prevention/Tobacco/Smoking-Cessation-Pregnancy/102 http://www.amchp.org/programsandtopics/BestPractices/InnovationStation/Pages/Innovation-Station.aspx



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effectiveness by asking the following questions: What about the intervention works? How does it work? In what contexts does it work? And finally, for whom does it work and for whom does it not work?103 Details about this approach are included in the NPM Toolkit.

As you use resources from the Toolkit, we encourage you to share your thoughts and feedback. This will enable the MCH Evidence Center to track use of the resources in a consistent manner to learn how to better design implementation strategies, monitor uptake and use of interventions, and provide platforms for future research driven by the field.

2. Use a structured approach to integrate evidence into your work to measure process and outcomes. There are many effective approaches for identifying needs and developing programs to address those needs. The MCH Evidence Center uses Results-Based Accountability (RBA) as a suggested method to align program performance (performance-based accountability; e.g., measurement of ESMs) with population goals (population-based accountability; e.g. NPMs and NOMs) and improve measurement of activities.

RBA helps you decide which outcome you would like to address. Begin the process of selecting an intervention by deciding which outcome you would like to address and how you will measure your success in changing that outcome. Choosing the most fitting intervention for your community, setting, population, and context benefits from careful attention to the expected/intended outcomes of the strategy.

• RBA helps to ensure that ESMs align with and advance achievement of NPMs (and eventually NOMs) through a series of 7 performance accountability questions that address: – Desired impact change on a targeted group. – Mechanisms to deliver services effectively. – Ways to engage appropriate partners. – How to identify what specifically works to produce measurable outcomes.

• RBA works to strengthen measurement of ESMs through a 4-quadrant system to increase measurement of ESMs by addressing: – Quantity of the effort (what did we do?—most basic measure). – Quality of the effort (how well did we do it?). – Quantity of the effect (is anyone better off?). – Quality of the effect (how are they better off?—most advanced measure).

103 Center on the Developing Child, Harvard University https://developingchild.harvard.edu/



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3. Incorporate MCH principles and needs to focus your work. We are mindful of the needs of MCH programs and the need to strategically use and document Title V resources to advance NPMs. This is done by:• Linking your work back to MCH priorities so that interventions developed are meaningful,

measurable, and achievable.• Ensuring that ESMs always measure the work that is directly related to the appropriate NPM,

address inequities to advance health equity, and are effective with multiple population groups.• Leveraging the resources of and coordinating with HRSA MCHB-funded centers.

To accomplish these goals, the MCH Evidence Center suggests using Harvard University’s Frontiers of Innovation approach to ask the following questions about evidence-based and evidence-informed interventions as you incorporate them into your work:• What about it works? If we understand the key ingredients, we can replicate them.• How does it work? Being specific about the underlying mechanisms can help us increase

the impact.• For whom does it work, and for whom does it not work? When we know who is and is not

responding, we can make targeted adaptations to improve outcomes.• In what contexts does it work? By evaluating the context in which a program is implemented,

we can adapt it for other settings.

With all the time, effort, and resources that go into incorporating evidence-based and evidence-informed interventions into your programming, it is critical to share your successes with Title V state and national programs, legislators, and others who can help support policy change and provide funding for initiatives to reduce smoking during pregnancy. To aid in this task, we encourage you to gather and report information on your use of these interventions to Title V program leaders to shine the spotlight on progress being made at the practice level to reduce harm associated with smoking in pregnancy. These data points could be used to leverage additional funding and/or policy change in the future.

As you work through the process of moving from evidence to action, please reach out to our staff with questions and for technical assistance. We are available to assist you when you need help. Email us at [email protected].

FIGURES AND TABLES


63

FIGURES AND TABLES

FIGURE 1. FLOW CHART OF THE REVIEW PROCESS AND RESULTS

SCRE

ENIN

GID

ENTI

FICA

TIO

NEL

IGIB

ILIT

YIN

CLU

DED

Records identified through database searching (n = 4,317)

PubMed (n = 2,360)Cochrane (n = 794)CINAHL (n = 770)

PsycINFO (n = 393)

Additional records identified through systematic review (n = 0)

Records screened after duplicates removed

(n = 3,619)

Records excluded in title and abstract screening

(n = 3,503)

Full-text articles assessed for eligibility

(n = 116)

Full-text articles excluded due to failure to meet all

inclusion criteria (n = 74)

Peer-reviewed studies included (n = 42)

Grey literature included (n = 0)

Sources included in this review (n = 42)

FIGURES AND TABLES


64

FIGURE 2. EVIDENCE CONTINUUM

Counseling (n=6)

Incentives (n=7)


Nicotine replacement therapy (n=1)

H e a l t h c a r e p r o v i d e r t r a i n i n g ( n = 2 )

Automatic initiation of

smoking cessation program (n=3)

Feedback (n=1)

Evidenced-Based

EVIDENCE AGAINST

EMERGING EVIDENCE

MIXED EVIDENCE

EXPERT OPINION

MODERATE EVIDENCE



Exercise (n=3)

CLIN

IC-B

ASE

D SE

TTIN

G


Counseling (n=1)

Social support (n=1)

COM

MU

NIT

Y-BA

SED

SETT

ING

Counseling (n=4)

Counseling + Feedback +

Incentives (n=1)

Health edcuation + Social support

(n=1)

Journaling (n=1)

ELEC

TRO

NIC

SET

TIN

G

Health edcuation

(n=1)

H e a l t h e d u c a t i o n + I n c e n t i v e s ( n = 2 )

Policy (n=5)

POPU

LATI

ON

-BA

SED

SETT

ING

FIGURES AND TABLES


65

TABLE 1: DETAILED SEARCH STRATEGIESDATABASE SEARCH STRATEGIES

PubMed #1 “Pregnancy”[Mesh:NoExp] OR “Pregnancy Trimesters”[Mesh] OR “Pregnant Women”[Mesh] OR “Prenatal Care”[Mesh] OR “Prenatal Education”[Mesh] OR “Preconception Care”[Mesh]

#2 pregnanc*[tiab] OR pregnant[tiab] OR antenatal[tiab] OR “ante natal”[tiab] OR “prenatal”[tiab] OR “pre natal”[tiab] OR “preconception”[tiab] or “pre conception”[tiab]

#3 #1 OR #2#4 “Tobacco Use Cessation”[Mesh] OR “Smoking Cessation”[Mesh] OR “Smoking/adverse effects”[Mesh] OR

“Smoking/drug therapy”[Mesh] OR “Smoking/epidemiology”[Mesh] OR “Smoking/prevention and control”[Mesh] OR “Smoking/psychology”[Mesh] OR “Smoking/therapy”[Mesh] OR “Tobacco Use Cessation Products”[Mesh]

#5 smok*[tiab] OR cigarette*[tiab] OR e-cig*[tiab] OR ecig*[tiab] OR electronic cig*[tiab] OR tobacco[tiab]) AND (cessation*[tiab] OR quit*[tiab] OR stop*[tiab] OR abstain*[tiab]

#6 #4 OR #5 #7 “Animals”[Mesh] NOT “Humans”[Mesh]#8 (#3 AND #6) NOT #7

Cochrane #1 MeSH descriptor: [Pregnancy] explode all trees#2 MeSH descriptor: [Pregnancy Trimesters] explode all trees#3 MeSH descriptor: [Pregnant Women] explode all trees#4 MeSH descriptor: [Prenatal Care] explode all trees#5 MeSH descriptor: [Prenatal Education] explode all trees#6 MeSH descriptor: [Preconception Care}#7 pregnanc* or pregnant or antenatal or “ante natal” or prenatal or “pre natal” or “preconception” or “pre conception”#8 {or #1-#7}#9 MeSH descriptor: [Tobacco Use Cessation] explode all trees#10 MeSH descriptor: [Tobacco Use Cessation Products] explode all trees#11 MeSH descriptor: [Smoking Cessation] explode all trees#12 MeSH descriptor: [Smoking] explode all trees#13 (smok* or cigarette* or “e-cig*” or ecig* or “electronic cig*” or tobacco) and (cessation* or quit* or stop* or

abstain*)#14 {or #9-#13}#15 #8 and #14

CINAHL S1 (MH “Pregnancy+”) OR (MH “Pregnancy Trimesters+”) OR (MH “Expectant Mothers”) OR (MH “Prenatal Care”) OR (MH “Prepregnancy Care”) OR (MH Perinatal Care)

S2 TI (pregnanc* OR pregnant OR antenatal OR “ante natal” OR “prenatal” OR “pre natal” OR “preconception” OR “pre conception” OR “perinatal”) OR AB(pregnanc* OR pregnant OR antenatal OR “ante natal” OR “prenatal” OR “pre natal” OR “preconception” or “pre conception” “ OR “perinatal) OR SU(pregnanc* OR pregnant OR antenatal OR “ante natal” OR “prenatal” OR “pre natal” OR “preconception” or “pre conception” “ OR “perinatal)

S3 S1 OR S2S4 (MH Smoking) OR (MH “Smoking Cessation”) OR (MH “Smoking Cessation Programs”) OR MH Tobacco) OR

(MH “Tobacco Use Cessation Products”)S5 TI ((smok* OR cigarette* OR “e-cig*” OR ecig* OR “electronic cig*” OR tobacco OR vape OR vaping OR

“secondhand smok*” OR “second-hand smok*” OR “second hand smok*”) AND (cessation* OR quit* OR stop* OR abstain* OR reduc* OR prevent*)) OR AB((smok* OR cigarette* OR “e-cig*” OR ecig* OR “electronic cig*” OR tobacco OR vape OR vaping OR “secondhand smok*” OR “second-hand smok*” OR “second hand smok*) AND (cessation* OR quit* OR stop* OR abstain* OR reduc* OR prevent*)) OR SU((smok* OR cigarette* OR “e-cig*” OR ecig* OR “electronic cig*” OR tobacco OR vape OR vaping OR “secondhand smok*” OR “second-hand smok*” OR “second hand smok*) AND (cessation* OR quit* OR stop* OR abstain* OR reduc* OR prevent*))

S6 S4 OR S5S7 S3 AND S6

FIGURES AND TABLES


66

DATABASE SEARCH STRATEGIES

PsycINFO 1 exp pregnancy2 exp pregnancy outcomes3 exp prenatal care4 (pregnan$ or antenatal or “ante natal” or prenatal or “pre natal” or preconception or “pre conception” or perinatal or

“peri natal”).ti.5 1 or 2 or 3 or 46 Smoking Cessation7 tobacco smoking8 (smok* or cigarette* or e-cig* or ecig* or tobacco or vape* or vaping or secondhand smok* or second-hand smok*).

ti.9 (cessation* or quit* or stop* or abstain* or reduc* or interven* or prevent* or control*)10 6 or 7 or 811 5 and 1012 8 and 913 6 or 7 or 11 or 1214 5 and 1315 animals/ not humans/16 14 not 1517 limit 16 to yr=“2012 -Current”18 limit 16 to yr=“2010 -Current”19 limit 16 to yr=“2015 -Current”

TABLE 1: Continued

FIGURES AND TABLES


67

TABLE 2: EVIDENCE RATING CRITERIALEVEL OF EVIDENCE EVIDENCE RATING EVIDENCE CRITERIA: TYPE EVIDENCE CRITERIA: STUDY RESULTS

Evidence-Based Scientifically Rigorous Peer-reviewed study results are drawn only from:• Randomized controlled trials, and/or• Quasi-experimental studies with pre-

post measures and control groups

Preponderance of studies have statistically significant favorable findings

Moderate Evidence Peer-reviewed study results are drawn from a mix of:• Randomized controlled trials• Quasi-experimental studies with pre-

post measures and control groups• Quasi-experimental studies with pre-

post measures without control groups• Time trend analyses

Preponderance of studies have statistically significant favorable findings

Evidence-Informed Expert Opinion Grey literature Experts deem the intervention as favorable based on scientific review

Emerging Evidence Peer-reviewed study results are drawn from a mix of:• Randomized controlled trials• Quasi-experimental studies with pre-


post measures without control groups• Time trend analyses• Cohort studies

Studies with a close-to-evenly distributed mix of statistically favorable and not significant findings

Only cohort studies with preponderance of statistically significant favorable findings

Grey literature Experts deem the intervention as favorable

Mixed Evidence Peer-reviewed study results are drawn from a mix of:• Randomized controlled trials• Quasi-experimental studies with pre-



Studies with a close-to-evenly distributed mix of statistically favorable, unfavorable, and/or not significant findings

Grey literature Experts deem the intervention as having mixed evidence

Evidence-Based or Evidence-Informed

Evidence Against Peer-reviewed study results are drawn from a mix of:• Randomized controlled trials• Quasi-experimental studies with pre-



Preponderance of studies do not have statistically significant findings or have statistically significant unfavorable findings

Grey literature Experts deem the intervention as being ineffective or unfavorable

FIGURES AND TABLES


68

TABLE

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cur

rent

ly

smok

ing

or sm

oked

in th

e pa

st 2

w

eeks

20Si

ngle

gro

up p

re-p

ost t

est

eval

uatio

n pi

lot

Bai

ley,

S.R

. (20

17)

USA

Com

mun

ity h

ealth

cen

ters

(CH

C)

All

smok

ers o

ver 1

8 ye

ars o

f age

w

ith a

t lea

st o

ne p

rimar

y ca

re v

isit

to o

ne o

f the

stud

y C

HC

s in

2010

, 20

12, o

r 201

4 as

wel

l as a

subs

et o

f pr

egna

nt w

omen

Rev

iew

of h

ealth

reco

rds f

or 1

6,80

2 pa

rtici

pant

s in

2010

, 17,

631

in 2

012

and

18,1

10 in

201

4

Qua

si e

xper

imen

tal

cros

s-se

ctio

nal (

Non

-ra

ndom

ized

eva

luat

ion

of

a po

licy

chan

ge)

Bai

ley,

B. A

. (20

15)

USA

Pren

atal

car

e cl

inic

sPr

egna

nt w

omen

smok

ers w

ho

rece

ive

Med

icai

d an

d pr

enat

al c

are

1486

RC

T

Bar

thol

omew

(201

6)U

SASt

ate

and

loca

l pol

icie

s; S

tate

Vita

l St

atis

tics r

ecor

d H

ealth

reco

rds o

f sin

glet

on b

irths

fo

r Wes

t Virg

inia

resi

dent

s bet

wee

n 19

95-2

010

293,

715

Qua

si e

xper

imen

tal

cros

s-se

ctio

nal -

regr

essi

on

anal

ysis

Bel

l (20

18)

Engl

and

Nat

iona

l Hea

lth S

ervi

ce(N

HS)

an

tena

tal c

linic

s H

ealth

reco

rds o

f sin

glet

on b

irths

to

mot

hers

who

smok

ed a

nd d

id n

ot

smok

e

37,7

26Q

uasi

exp

erim

enta

l Cro

ss-

sect

iona

l and

Cos

t-ben

efit

anal

ysis

Ber

lin (2

014)

Fran

ceM

ater

nity

war

dsPr

egna

nt sm

oker

s age

d m

ore

than

18

yea

rs a

nd b

etw

een

12 a

nd 2

0 w

eeks

’ ges

tatio

n, w

ho sm

oked

at

leas

t five

cig

aret

tes a

day

and

scor

ed

at le

ast 5

on

a m

otiv

atio

nal s

cale

of

quitt

ing

smok

ing

(ran

ge 0

-10)

402

(203

to n

icot

ine

patc

hes,

199

to

plac

ebo

patc

hes)

RC

T- R

ando

miz

ed, d

oubl

e bl

ind,

pla

cebo

con

trolle

d,

para

llel g

roup

, mul

ticen

ter

trial

FIGURES AND TABLES


69

STU

DY

CO

UN

TRY

SETT

ING

STU

DY

SAM

PLE

STU

DY

DES

IGN

TARG

ET S

AM

PLE

SAM

PLE

SIZE

Bro

wn

(201

6)U

SAPa

rtici

pant

s in

the

Nat

iona

l Sur

vey

of D

rug

Use

and

Hea

lth (N

SDU

H)

2010

-201

3

Non

-pre

gnan

t and

pre

gnan

t wom

en

12 to

44

year

s old

with

and

with

out

heal

th in

sura

nce

from

larg

e da

ta se

t af

ter p

assa

ge o

f AC

A

97,7

88Q

uasi

exp

erim

enta

l cro

ss

sect

iona

l

Buc

hana

n (2

017)

USA

Aca

dem

ic m

edic

al c

ente

r Sm

oker

s adm

itted

to th

e pe

rinat

al

units

5649

Qua

si e

xper

imen

tal c

ross

se

ctio

nal e

valu

atio

n

Cam

pbel

l (20

17)

UK

Ant

enat

al c

linic

sD

ata

on P

regn

ant w

omen

who

sm

oke

rece

ivin

g N

atio

nal H

ealth

Se

rvic

es (N

HS)

obs

tetri

c se

rvic

es

2287

wom

en w

ho re

ceiv

ed c

are

befo

re in

itiat

ion

of C

O b

reat

h te

st

inte

rven

tion,

229

3 af

ter

Qua

si e

xper

imen

tal c

ross

se

ctio

nal

Che

rtok

(201

5)U

SAPr

enat

al c

are

clin

ics

Preg

nant

wom

en w

ho sm

oked

and

w

ere

will

ing

to q

uit o

r cut

dow

n sm

okin

g re

ceiv

ing

pren

atal

car

e

35Si

ngle

gro

up p

re-p

ost t

est

eval

uatio

n pi

lot

Col

eman

-Cow

ger

(201

8)U

SAO

bste

trics

clin

icLo

w-in

com

e pr

egna

nt w

omen

at

tend

ing

thei

r firs

t pre

nata

l vis

it at

a

sing

le a

cade

mic

obs

tetri

cs c

linic

130

RC

T pi

lot

Cum

min

s (20

16)

USA

Tele

phon

ePr

egna

nt sm

oker

s in

the

first

27

wee

ks o

f ges

tatio

n w

ho a

re fi

rst-

time

calle

rs to

a st

ate

quitl

ine

1173

RC

T

Eddy

(201

5)N

ew Z

eala

ndH

ome-

base

d m

idw

ife se

rvic

esPr

egna

nt w

omen

who

smok

ed

rece

ivin

g m

idw

ife c

are

in N

ew

Zeal

and

6 m

idw

ives

, 101

wom

enC

ohor

t /Pr

ospe

ctiv

e ob

serv

atio

nal s

tudy

Engl

and

(201

7)U

SASt

ate

live

birth

dat

abas

esPr

egna

nt w

omen

who

gav

e bi

rth in

In

dian

a, K

entu

cky

and

Ohi

o60

,747

stud

y gr

oup,

209

,053

po

pula

tion/

cont

rol

Qua

si e

xper

imen

tal c

ross

se

ctio

nal

Falli

n-B

enne

t (20

19)

USA

Uni

vers

ity o

bste

tric

and

gyne

colo

gy

clin

ics

Preg

nant

wom

en o

ver 1

8, sm

oked

an

d ex

pres

sed

inte

rest

in q

uitti

ng50

Qua

si e

xper

imen

tal c

ross

se

ctio

nal -

pilo

t

Forin

ash

(201

8)U

SAM

ater

nal f

etal

car

e ce

nter

En

glis

h-sp

eaki

ng p

regn

ant w

omen

at

leas

t 18

year

s old

rece

ivin

g ca

re

at th

e m

ater

nal f

etal

car

e ce

nter

and

w

ere

will

ing

to se

t a sm

okin

g *q

uit*

da

te p

rior t

o 35

wee

ks g

esta

tion.

49R

CT-

pilo

t

Glo

ver (

2016

)N

ew Z

eala

ndH

ome-

base

d cu

ltura

lly ta

ilore

d co

mm

unity

hea

lth sm

okin

g ce

ssat

ion

supp

ort

Preg

nant

Māo

ri w

omen

smok

ers

67Pr

ospe

ctiv

e in

terv

entio

n tri

al- e

valu

atio

n

TABLE

3: C

ontin

ued

FIGURES AND TABLES


70

STU

DY

CO

UN

TRY

SETT

ING

STU

DY

SAM

PLE

STU

DY

DES

IGN

TARG

ET S

AM

PLE

SAM

PLE

SIZE

Grif

fis (2

016)

USA

Hom

e vi

sitin

g pr

ogra

ms

Engl

ish

or S

pani

sh sp

eaki

ng

mot

hers

who

smok

ed d

urin

g pr

egna

ncy

who

cur

rent

ly

parti

cipa

ted

in a

hom

e vi

sitin

g pr

ogra

m a

nd re

ceiv

ed w

elfa

re

bene

fits

10,2

96 w

omen

: 259

5 st

udy

parti

cipa

nts a

nd 7

701

cont

rols

Coh

ort -

Mix

ed

met

hods

usi

ng a

re

trosp

ectiv

e co

hort

of p

rope

nsity

scor

e

Han

kins

(201

6)U

SASt

atew

ide

and

com

mun

ity: S

tate

, ci

ty, c

ount

y, lo

cal,

wor

kpla

ce a

nd

bar/r

esta

uran

t sm

okin

g ba

ns

Smok

ing

mot

hers

ove

r age

19

with

si

ngle

ton

birth

s and

thos

e th

at

occu

rred

in th

e sa

me

coun

ty a

s m

othe

r’s c

ount

y of

resi

denc

e

Leve

l of o

bser

vatio

n by

cou

nty=

3,

141

Qua

si e

xper

imen

tal c

ross

se

ctio

nal

Har

ris (2

015)

USA

Hom

e- b

ased

smok

ing

cess

atio

n pr

ogra

ms

Engl

ish

spea

king

pre

gnan

t wom

en

less

than

12

wee

ks o

f pre

gnan

cy a

t th

e be

ginn

ing

in ru

ral A

ppal

achi

a

17R

CT

pilo

t

Hav

ard

(201

8)A

ustra

liaSt

atew

ide

and

com

mun

ity: n

atio

nal

antis

mok

ing

cam

paig

nsH

ealth

reco

rds o

f all

preg

nanc

ies

resu

lting

in a

live

birt

h be

twee

n 20

03 to

201

1 in

one

stat

e (N

ew

Sout

h W

ales

)

800,

619

preg

nanc

ies a

mon

g 53

4,51

3 w

omen

in N

ew S

outh

Wal

esQ

uasi

exp

erim

enta

l cro

ss

sect

iona

l

Jin

(201

8)C

hina

Uni

vers

ity h

ospi

tal c

linic

Preg

nant

smok

ers a

ged

from

18

to 4

0 ye

ars o

ld, 1

2 to

24

wee

ks o

f ge

stat

ion,

with

cur

rent

cig

aret

te

cons

umpt

ion

of m

ore

than

1

ciga

rette

dai

ly w

ho c

ould

wal

k fo

r 20

min

utes

dai

ly

176

Coh

ort s

tudy

- R

etro

spec

tive

obse

rvat

ion

Lee

(201

5)U

SAU

nive

rsity

hos

pita

l pre

nata

l car

e cl

inic

Rac

ial a

nd e

thni

cally

div

erse

urb

an

preg

nant

smok

ers

277,

140

in th

e in

terv

entio

n gr

oup

and

137

in th

e co

ntro

l gro

upR

CT

Lope

z (2

015a

)U

SAO

bste

tric

prac

tices

and

Wom

en,

Infa

nts,

and

Chi

ldre

n (W

IC)

prog

ram

Engl

ish

spea

king

Wom

en, I

nfan

ts,

and

Chi

ldre

n (W

IC) p

rogr

am

reci

pien

ts w

ho w

ere

preg

nant

and

ne

wly

pos

tpar

tum

smok

ers a

t ris

k fo

r pos

tpar

tum

dep

ress

ion

289

Qua

si e

xper

imen

tal

cros

s sec

tiona

l- re

peat

ed

mea

sure

s sec

onda

ry d

ata

anal

ysis

Lope

z (2

015b

)U

SAU

nive

rsity

out

patie

nt re

sear

ch c

linic

Engl

ish

spea

king

Wom

en, I

nfan

ts,

and

Chi

ldre

n (W

IC) p

rogr

am

reci

pien

ts w

ho w

ere

preg

nant

sm

oker

s who

resi

ded

in th

e co

unty

an

d di

d no

t mov

e fo

r 6 m

onth

s, no

ot

her s

ubst

ance

use

repo

rted

236

Coh

ort-

pros

pect

ive

sing

le

trial

dat

a co

mbi

ned

with

ra

ndom

gro

up a

ssig

nmen

t co

horts

TABLE

3: C

ontin

ued

FIGURES AND TABLES


71

STU

DY

CO

UN

TRY

SETT

ING

STU

DY

SAM

PLE

STU

DY

DES

IGN

TARG

ET S

AM

PLE

SAM

PLE

SIZE

Min

ian

(201

6)C

anad

aO

nlin

e fo

rum

for p

regn

ant w

omen

Preg

nant

wom

en in

an

onlin

e fo

rum

5Q

uasi

exp

erim

enta

l cro

ss

sect

iona

l - su

rvey

Mor

gan

(201

6)U

K-S

cotla

ndU

K N

atio

nal H

ealth

Ser

vice

s (N

HS)

an

tena

tal c

linic

s Pr

egna

nt w

omen

who

smok

ed

rece

ivin

g N

HS

ante

nata

l ser

vice

s39

M

ixed

met

hods

cas

e se

ries

Nau

ghto

n (2

017)

UK

UK

Nat

iona

l Hea

lth S

ervi

ces (

NH

S)

ante

nata

l clin

ics

Wom

en 1

6 ye

ars a

nd o

ver,

less

than

25

wee

ks p

regn

ant,

who

had

smok

ed

at le

ast fi

ve c

igar

ette

s dai

ly b

efor

e pr

egna

ncy

and

at le

ast o

ne p

er d

ay

at e

nrol

men

t, ab

le to

und

erst

and

writ

ten

Engl

ish

and

owne

d a

mob

ile p

hone

with

text

mes

sagi

ng

func

tiona

lity

407

-203

to M

QU

IT, 2

04 to

usu

al

care

RC

T

Ola

iya

(201

5)U

SAW

omen

, Inf

ants

and

Chi

ldre

n cl

inic

s in

Ohi

oA

ll pr

egna

nt w

omen

in th

eir fi

rst

trim

este

r who

repo

rted

smok

ing

atte

ndin

g a

Wom

en, I

nfan

ts a

nd

Chi

ldre

n cl

inic

in O

hio

that

was

tra

ined

to u

se th

e 5A

’s sm

okin

g ce

ssat

ion

pack

age

71,5

26Q

uasi

exp

erim

enta

l cro

ss

sect

iona

l

Ols

on (2

019)

USA

Pren

atal

clin

ics i

n fe

dera

lly q

ualifi

ed

heal

th c

ente

rsLo

w in

com

e pr

egna

nt sm

oker

s se

rved

in c

linic

setti

ngs w

ho h

ad

not s

pont

aneo

usly

qui

t on

lear

ning

of

thei

r pre

gnan

cy a

nd w

ere

still

sm

okin

g at

the

time

of th

eir fi

rst

pren

atal

vis

it

175

star

ted

prog

ram

, 134

follo

wed

th

roug

h to

pos

tpar

tum

vis

itC

ohor

t- co

ntro

l tria

l with

no

n-ra

ndom

ass

ignm

ent

Pass

ey (2

018)

Aus

tralia

Abo

rigin

al M

ater

nal a

nd In

fant

H

ealth

Ser

vice

s clin

ics

Preg

nant

abo

rigin

al w

omen

seek

ing

pren

atal

car

e at

hea

lth se

rvic

es si

tes

who

wer

e sm

okin

g an

d ol

der t

han

16 y

ears

and

less

than

20

wee

ks

gest

atio

n w

ho w

ere

loca

l res

iden

ts

38, 1

9 co

mpl

eted

the

prog

ram

Sing

le g

roup

pre

-pos

t tes

t

Patte

n (2

019)

USA

Prim

ary

care

cen

ter

Preg

nant

Ala

skan

nat

ive

wom

en

who

smok

ed re

ceiv

ing

pren

atal

ca

re a

t a p

rimar

y ca

re c

ente

r in

Anc

hora

ge, A

K

60 -3

0 in

terv

entio

n, 3

0 co

ntro

lR

CT-

pilo

t

TABLE

3: C

ontin

ued

FIGURES AND TABLES


72

TABLE

3: C

ontin

ued

STU

DY

CO

UN

TRY

SETT

ING

STU

DY

SAM

PLE

STU

DY

DES

IGN

TARG

ET S

AM

PLE

SAM

PLE

SIZE

Rey

nold

s (20

19)

UK

Ant

enat

al c

linic

sSe

lf-re

porte

d sm

oker

s who

wer

e ag

ed o

ver 1

8 ye

ars,

less

than

17

wee

ks g

esta

tion,

und

erst

ood

Engl

ish,

had

acc

ess t

o th

e In

tern

et,

and

had

capa

city

to g

ive

cons

ent

22- 1

3 in

terv

entio

n gr

oup,

9 c

ontro

l gr

oup

RC

T

Sloa

n (2

017)

UK

Mob

ile b

ased

Preg

nant

wom

en sm

oker

s age

d 17

-37

who

had

rece

ived

the

MiQ

uit t

ext

mes

sagi

ng in

terv

entio

n as

par

t of a

la

rger

RC

T

15Q

ualit

ativ

e in

terv

iew

Stie

gler

(201

6)G

erm

any

Inte

rnet

bas

edA

dult

preg

nant

wom

en w

ith a

t lea

st

one

inst

ance

of c

onsu

mpt

ion

of

alco

hol a

nd/o

r tob

acco

in p

regn

ancy

, ad

equa

te k

now

ledg

e of

Ger

man

25R

CT-

pilo

t

Tapp

in (2

015)

UK

Hos

pita

l and

com

mun

ity-b

ased

he

alth

car

e cl

inic

sEn

glis

h sp

eaki

ng p

regn

ant w

omen

w

ho sm

oked

rece

ivin

g ob

stet

rical

ca

re th

roug

h U

K N

atio

nal H

ealth

Se

rvic

es (N

HS)

609

-306

inte

rven

tion,

303

con

trol

RC

T

Uss

her (

2015

a)U

KH

ospi

tal a

nten

atal

clin

ics

Preg

nant

smok

ers a

ges 1

6-50

yea

rs

at 1

0-24

wee

ks o

f ges

tatio

n,

ciga

rette

con

sum

ptio

n of

five

or

mor

e da

ily b

efor

e pr

egna

ncy,

cu

rren

tly sm

okin

g on

e or

mor

e ci

gare

ttes d

aily

, and

abl

e to

wal

k co

ntin

uous

ly fo

r 15

min

utes

784-

392

inte

rven

tion

RC

T

Uss

her (

2015

b)U

KC

omm

unity

hos

pita

l ant

enat

al

clin

ics

Wom

en b

etw

een

10 a

nd 2

4 w

eeks

’ ge

stat

ion

smok

ing

5 or

mor

e ci

gare

ttes a

day

bef

ore

preg

nanc

y an

d on

e or

mor

e du

ring

preg

nanc

y

785-

392

inte

rven

tion,

393

con

trol

RC

T

Wen

(201

9)U

SAC

omm

unity

-bas

ed p

rena

tal c

linic

sEn

glis

h sp

eaki

ng p

regn

ant w

omen

w

ho a

re c

urre

nt sm

oker

s with

out

alco

hol o

r dru

g de

pend

ency

or

men

tal h

ealth

dis

orde

rs

30C

ohor

t-Mul

tiple

-bas

elin

e in

terv

entio

n pi

lot s

tudy

-m

ultip

le in

terr

upte

d tim

e se

ries a

ppro

ach

Zvor

sky

(201

5)U

SAW

omen

, Inf

ants

and

Chi

ldre

n cl

inic

ob

stet

rical

pra

ctic

es

Econ

omic

ally

-dis

adva

ntag

ed

preg

nant

and

new

ly p

ostp

artu

m

smok

ers a

t ris

k fo

r dep

ress

ion.

289

Qua

si e

xper

imen

tal c

ross

se

ctio

nal

FIGURES AND TABLES


73

TABLE

4: I

NTE

RVEN

TIO

N D

ESC

RIPT

ION

SST

UD

Y C

OM

PARI

SON

GRO

UP

DES

CRI

PTIO

N O

F IN

TERV

ENTI

ON

STU

DY

LEN

GTH

DAT

A C

OLL

ECTI

ON

Abr

oms (

2017

a)C

ontro

l gro

up re

ceiv

ed a

sing

le

text

mes

sage

with

a re

ferr

al

to a

tele

phon

e qu

itlin

e af

ter

enro

llmen

t and

mai

led

self-

help

pr

inte

d m

ater

ials

The

aim

of t

he st

udy

was

to e

xam

ine

the

acce

ptab

ility

and

feas

ibili

ty o

f Sm

okef

reeM

OM

, a n

atio

nal s

mok

ing

cess

atio

n te

xt m

essa

ging

pro

gram

for

preg

nant

smok

ers.

Parti

cipa

nts r

ando

miz

ed to

the

Smok

efre

eMO

M in

terv

entio

n gr

oup

wer

e m

aile

d se

lf-he

lp m

ater

ials

from

the

CD

C o

n qu

ittin

g sm

okin

g w

hile

pr

egna

nt a

nd te

xt m

essa

ges w

ere

sche

dule

d ar

ound

the

parti

cipa

nt’s

qui

t dat

e an

d ba

by’s

due

dat

e. U

sers

rece

ived

app

roxi

mat

ely

3-6

text

mes

sage

s/da

y w

ith a

hi

gher

vol

ume

arou

nd th

e qu

it da

te a

nd b

aby’

s due

dat

e. W

hile

the

stud

y en

ded

3 m

onth

s afte

r enr

ollm

ent,

mes

sage

s wer

e de

sign

ed to

last

6 m

onth

s afte

r the

qui

t da

te a

nd 3

mon

ths a

fter t

he b

aby’

s due

dat

e. P

artic

ipan

ts w

ere

give

n m

onet

ary

ince

ntiv

es fo

r com

plet

ing

the

inte

rvie

ws f

or e

valu

atio

n.

3 m

onth

s B

asel

ine,

1 m

onth

, and

3

mon

ths a

fter e

nrol

lmen

t

Abr

oms (

2017

b)C

ontro

l gro

up re

ceiv

ed

Text

4Bab

y 3

mes

sage

s per

w

eek

and

inte

rven

tion

rece

ived

Te

xt4b

aby

and

Qui

t4B

aby

1-8

daily

mes

sage

s tha

t tap

ered

ove

r 6

mon

ths

Inve

stig

ated

the

supp

lem

enta

l effe

ct o

f add

ing

a sm

okin

g-ce

ssat

ion

text

m

essa

ging

pro

gram

Qui

t4ba

by, t

o an

est

ablis

hed

text

mes

sagi

ng p

rogr

am,

Text

4bab

y. T

ext4

baby

is th

e la

rges

t hea

lth te

xt m

essa

ging

serv

ice

for p

regn

ant

wom

en a

nd m

othe

rs in

the

U.S

with

3 w

eekl

y te

xts.

Qui

t 4B

aby

uses

dai

ly te

xt

mes

sage

s with

the

oppo

rtuni

ty fo

r use

r res

pons

es to

requ

est m

ore

supp

ort t

o qu

it sm

okin

g.

6 m

onth

s1,

3 a

nd, 6

mon

ths a

fter

enro

llmen

t

Abr

oms (

2015

)N

o co

mpa

rison

gro

upTh

e st

udy

aim

ed to

dem

onst

rate

the

feas

ibili

ty a

nd a

ccep

tabi

lity

of Q

uit4

baby

fo

r wom

en c

urre

ntly

enr

olle

d in

Tex

t4ba

by, a

per

inat

al h

ealth

text

mes

sagi

ng

prog

ram

. It w

as d

evel

oped

aro

und

a la

rge,

subs

crip

tion-

base

d te

xt-m

essa

ging

se

rvic

e fo

r pre

gnan

t wom

en in

ord

er to

max

imiz

e its

pot

entia

l to

reac

h la

rge

num

bers

of p

regn

ant s

mok

ers.

Preg

nant

smok

ers w

ho a

gree

d to

par

ticip

ate

in

the

pilo

t stu

dy re

ceiv

ed d

aily

text

mes

sage

s aim

ed a

t im

prov

ing

self-

effic

acy

for

quitt

ing

(with

enc

oura

gem

ent a

nd m

otiv

atio

nal m

essa

ges)

, des

crib

ing

outc

ome

expe

ctat

ions

from

qui

tting

, inc

reas

ing

soci

al su

ppor

t for

qui

tting

(via

“qu

itpal

”),

enab

ling

vica

rious

lear

ning

thro

ugh

the

mod

elin

g of

effe

ctiv

e qu

ittin

g st

rate

gies

an

d co

ping

skill

s, in

crea

sing

beh

avio

ral c

apab

ility

for q

uitti

ng, a

nd re

gula

rly

reco

mm

endi

ng c

allin

g a

quitl

ine.

Par

ticip

ants

rece

ived

a $

25 in

cent

ive

for e

ach

tele

phon

e su

rvey

they

com

plet

ed to

col

lect

feed

back

on

the

prog

ram

. Par

ticip

ants

ha

d th

e op

portu

nity

to te

xt k

eyw

ords

to th

e pr

ogra

m fo

r add

ition

al su

ppor

t or t

o op

t out

.

1 ye

ar, 1

mon

thB

asel

ine,

2 w

eeks

, and

4

wee

ks a

fter e

nrol

lmen

t

Bai

ley,

S.R

. (20

17)

No

com

paris

on g

roup

The

stud

y ex

amin

ed w

heth

er sm

okin

g st

atus

ass

essm

ent,

cess

atio

n as

sist

ance

, an

d od

ds o

f bei

ng a

cur

rent

smok

er c

hang

ed fo

r all

adul

ts a

nd a

subs

et o

f pr

egna

nt w

omen

afte

r Sta

ge 1

Cen

ters

for M

edic

are

and

Med

icai

d Se

rvic

es’

Mea

ning

ful U

se (M

U) o

f Ele

ctro

nic

Hea

lth R

ecor

d (E

HR

) Pro

gram

im

plem

enta

tion.

Sta

ge 1

MU

incl

uded

two

man

dato

ry to

bacc

o-sp

ecifi

c m

easu

res.

One

requ

ired

reco

rdin

g of

smok

ing

stat

us fo

r at l

east

50%

of p

atie

nts a

ged

>13

year

s. Th

e ot

her r

equi

red

reco

rdin

g th

e pe

rcen

tage

of p

atie

nts a

ged

>18

year

s w

ho w

ere

scre

ened

for t

obac

co u

se o

ne o

r mor

e tim

es w

ithin

24

mon

ths a

nd

rece

ived

a c

essa

tion

inte

rven

tion

if id

entifi

ed a

s a to

bacc

o us

er.

Rev

iew

of h

ealth

re

cord

s ove

r a 4

ye

ar p

erio

d

Elec

troni

c he

alth

re

cord

dat

a pr

ior t

o im

plem

enta

tion

(201

0)

and

year

s 201

2 an

d 20

14

FIGURES AND TABLES


74

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Bai

ley,

B.A

. (20

15)

His

toric

al d

ata

cont

rol g

roup

: pr

egna

nt sm

oker

s who

rece

ived

pr

enat

al c

are

prio

r to

2006

Trai

ned

heal

th e

duca

tors

use

d th

e 5A

s (A

sk, A

dvis

e, A

sses

s, A

ssis

t, A

rran

ge)

mod

el p

lus e

duca

tion

and

mot

ivat

iona

l int

ervi

ewin

g to

hel

p pr

egna

nt sm

oker

s qu

it. F

or th

ose

who

indi

cate

d a

will

ingn

ess t

o qu

it of

2 o

r les

s on

a sc

ale

of 1

to

10, t

he h

ealth

edu

cato

r use

d ed

ucat

ion

and

mot

ivat

iona

l int

ervi

ewin

g (M

iller

&

Rol

lnic

k, 2

002)

in o

rder

to in

crea

se w

illin

gnes

s to

quit.

If th

is w

as n

ot su

cces

sful

, pa

tient

s wer

e pe

rmitt

ed to

dec

line

parti

cipa

tion

at th

is p

oint

. Whe

n at

tem

pts

to in

crea

se m

otiv

atio

n w

ere

succ

essf

ul, o

r if t

he w

oman

initi

ally

indi

cate

d a

will

ingn

ess t

o qu

it of

3 o

r mor

e, th

e he

alth

edu

cato

r mov

ed in

to a

brie

f in

terv

entio

n. T

his i

nter

vent

ion,

whi

ch u

sed

an e

xpan

ded

5A’s

mod

el a

nd in

volv

ed

mot

ivat

iona

l int

ervi

ewin

g, w

as p

erso

naliz

ed to

the

need

s of e

ach

patie

nt. I

n al

l cas

es it

invo

lved

add

ress

ing

bene

fits a

nd b

arrie

rs to

smok

ing

cess

atio

n,

and

build

ing

know

ledg

e, sk

ills,

self-

effic

acy,

and

reso

urce

s to

prom

ote

last

ing

beha

vior

cha

nge.

In p

artic

ular

, gap

s bet

wee

n cu

rren

t beh

avio

r, pe

rson

al g

oals

, an

d he

alth

reco

mm

enda

tions

wer

e hi

ghlig

hted

.

2 ye

ars,

23 m

onth

sQ

uit r

ates

by

the

end

of

the

2nd tr

imes

ter

Bar

thol

omew

(2

016)

No

com

paris

on g

roup

This

stud

y ex

plor

ed th

e ef

fect

of l

ocal

smok

e fr

ee p

olic

ies b

y as

sess

ing

the

effe

ct

of lo

cal s

mok

e fr

ee p

olic

y on

birt

h ou

tcom

es w

ith a

n ev

alua

tion

of v

aryi

ng

degr

ees o

f reg

ulat

ion

rest

rictiv

enes

s (co

mpr

ehen

sive

vs p

artia

l ban

) on

birth

ou

tcom

es a

nd p

rena

tal s

mok

ing

in o

ne st

ate

with

hig

h ra

tes o

f sm

okin

g in

the

gene

ral a

nd p

rena

tal p

opul

atio

ns.

15 y

ears

of d

ata

reco

rds a

naly

zed

Vita

l sta

tistic

s rec

ord

anal

ysis

of s

mok

ing

beha

vior

and

birt

h ou

tcom

es

Bel

l (20

18)

With

in g

roup

cha

ract

eris

tics

A p

acka

ge o

f mea

sure

s im

plem

ente

d in

trus

ts a

nd sm

okin

g ce

ssat

ion

serv

ices

, ai

med

at i

ncre

asin

g th

e pr

opor

tion

of p

regn

ant s

mok

ers q

uitti

ng d

urin

g pr

egna

ncy,

com

pris

ing

skill

s tra

inin

g fo

r hea

lthca

re a

nd sm

okin

g ce

ssat

ion

staf

f; un

iver

sal c

arbo

n m

onox

ide

mon

itorin

g w

ith ro

utin

e op

t-out

refe

rral

for s

mok

ing

cess

atio

n su

ppor

t; pr

ovis

ion

of c

arbo

n m

onox

ide

mon

itors

and

supp

ortin

g m

ater

ials

; and

an

expl

icit

refe

rral

pat

hway

and

follo

w-u

p pr

otoc

ol.

8 m

onth

sPr

e- in

terv

entio

n da

ta a

t 4 w

eeks

, Pos

t in

terv

entio

n, 4

mon

ths

of d

ata

Ber

lin (2

014)

Usu

al o

bste

trica

l car

e w

ith

plac

ebo

Nic

otin

e an

d id

entic

al p

lace

bo p

atch

es w

ere

adm

inis

tere

d fr

om q

uit d

ay u

p to

the

time

of d

eliv

ery.

Dos

es w

ere

adju

sted

to sa

liva

cotin

ine

leve

ls w

hen

smok

ing

to

yiel

d a

subs

titut

ion

rate

of 1

00%

(10

mg

and

15 m

g pa

tche

s, an

d th

e da

ily d

ose

rang

ed fr

om 1

0-30

mg/

day

depe

ndin

g on

the

cotin

ine

leve

l rea

ding

s). P

artic

ipan

ts

wer

e as

sess

ed m

onth

ly a

nd re

ceiv

ed b

ehav

iora

l sm

okin

g ce

ssat

ion

supp

ort

acco

rdin

g to

the

Fren

ch S

mok

ing

Ces

satio

n G

uide

lines

(200

4).

5 ye

ars,

4 m

onth

sSe

lf-id

entifi

ed q

uit

date

thro

ugh

the

end

of

preg

nanc

y, fo

llow

up

2 m

onth

s afte

r del

iver

y

Bro

wn

(201

6)N

o co

mpa

rison

gro

upA

naly

sis o

f the

impa

ct o

f hav

ing

heal

th in

sura

nce

on th

e sm

okin

g st

atus

of

wom

en o

f chi

ld b

earin

g ag

e3

year

s of d

ata

anal

yzed

1st, 2

nd, a

nd 3

rd tr

imes

ters

TABLE

4: C

ontin

ued

FIGURES AND TABLES


75

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Buc

hana

n (2

017)

No

com

paris

on g

roup

A c

ompr

ehen

sive

opt

-out

toba

cco

treat

men

t ser

vice

for i

npat

ient

s was

laun

ched

in

Feb

ruar

y 20

14. A

ll ad

mitt

ed p

atie

nts w

ere

scre

ened

for t

obac

co u

se a

nd

curr

ent t

obac

co u

sers

wer

e re

ferr

ed a

utom

atic

ally

for c

essa

tion

supp

ort w

hile

in

the

hosp

ital a

nd e

nrol

led

in a

follo

w-u

p ph

one-

base

d sy

stem

. The

opt

-out

toba

cco

treat

men

t inp

atie

nt se

rvic

e in

volv

ed th

ree

step

s; (1

) scr

eeni

ng: a

ll pa

tient

s wer

e as

ked

abou

t tob

acco

use

at a

dmis

sion

and

all

toba

cco

user

s wer

e au

tom

atic

ally

re

ferr

ed to

a to

bacc

o tre

atm

ent s

peci

alis

t (TT

S) th

roug

h th

e el

ectro

nic

med

ical

re

cord

(EM

R),

(2) r

efer

ral/I

npat

ient

cou

nsel

ing:

the

TTS

cond

ucte

d be

dsid

e ce

ssat

ion

coun

selin

g (p

sych

osoc

ial e

duca

tion,

mot

ivat

iona

l enh

ance

men

t, sk

ills b

ased

trai

ning

, and

rela

pse

prev

entio

n) w

hen

poss

ible

bas

ed o

n pa

tient

av

aila

bilit

y an

d th

e ca

selo

ad fo

r tha

t day

and

reco

mm

ende

d tre

atm

ent o

ptio

ns

to b

e ac

ted

upon

by

the

med

ical

car

e te

am, a

nd (3

) fol

low

-up:

all

toba

cco

user

s w

ere

auto

mat

ical

ly e

nrol

led

in a

n in

tera

ctiv

e vo

ice

resp

onse

(IV

R) s

yste

m, w

hich

pr

ospe

ctiv

ely

follo

wed

up

with

pat

ient

s for

30

days

afte

r dis

char

ge.

2 ye

ars,

1 m

onth

Dur

ing

hosp

ital s

tay

and

3, 1

4, a

nd 3

0 da

ys p

ost-

disc

harg

e

Cam

pbel

l (20

17)

Wom

en w

ho re

ceiv

ed c

are

befo

re th

e C

O b

reat

h te

st

impl

emen

tatio

n

Impl

emen

tatio

n of

CO

bre

ath

test

s to

dete

rmin

e w

ho is

offe

red

and

rece

ives

the

usua

l sm

okin

g ce

ssat

ion

care

. All

wom

en w

ho sc

ored

in th

e sm

okin

g ra

nge

on th

e br

eath

test

wer

e as

ked

to p

artic

ipat

e in

any

smok

ing

cess

atio

n ac

tiviti

es o

ffere

d.

Staf

f atte

mpt

ed to

cal

l eac

h w

oman

twic

e, a

nd if

a w

oman

was

unc

onta

ctab

le,

they

sent

a le

tter d

etai

ling

way

s to

cont

act t

he S

SS fo

r sup

port.

Wom

en w

ho

enga

ged

with

the

serv

ice

wer

e en

cour

aged

to se

t a q

uit d

ate

and

wer

e of

fere

d w

eekl

y be

havi

oral

supp

ort f

or u

p to

12

wee

ks, a

nd u

p to

12

wee

ks o

f nic

otin

e re

plac

emen

t the

rapy

in fo

rtnig

htly

bat

ches

on

an a

bstin

ent–

cont

inge

nt b

asis

at

no-c

ost t

o th

em. T

he b

ehav

iora

l sup

port

offe

red

to w

omen

was

bas

ed o

n th

e N

ICE

guid

elin

es.

5 m

onth

sA

t ent

ry a

nten

atal

car

e ul

traso

und

visi

t, qu

it da

te, a

nd a

t 4 w

eeks

Che

rtok

(201

5)N

o co

mpa

rison

gro

upTr

aine

d m

idw

ives

in fo

ur c

ount

y pr

enat

al c

linic

s to

prov

ide A

mer

ican

Col

lege

of

Obs

tetri

cian

s and

Gyn

ecol

ogis

ts’ (

AC

OG

) 5A’

s sm

okin

g ce

ssat

ion

met

hodo

logy

1

year

, 4 m

onth

sB

asel

ine,

at o

ne m

onth

fo

llow

ing

base

line,

2

mon

ths,

and

once

du

ring

the

first

2 m

onth

s po

stpa

rtum

Col

eman

-Cow

ger

(201

8)U

sual

car

e fo

r sm

okin

g ce

ssat

ion

in p

regn

ant w

omen

To p

ilot-t

est a

Pho

ne-b

ased

Pos

tpar

tum

Con

tinui

ng C

are

(PPC

C) p

roto

col

in a

dditi

on to

the

usua

l car

e fo

r sm

okin

g ce

ssat

ion

for p

regn

ant w

omen

to

dem

onst

rate

the

feas

ibili

ty o

f rec

ruitm

ent,

rand

omiz

atio

n, a

sses

smen

t, an

d im

plem

enta

tion

of th

e PP

CC

inte

rven

tion.

Offe

red

10 p

roac

tive

calls

beg

inni

ng

in th

e th

ird tr

imes

ter o

f pre

gnan

cy (w

eek

36) a

nd c

ontin

uing

thro

ugh

6 m

onth

s po

stpa

rtum

with

the

optio

n fo

r par

ticip

ants

to c

all i

n to

a 2

4/7

toll-

free

num

ber,

diffe

rent

from

the

stan

dard

refe

rral

stat

e qu

it lin

e, in

the

even

t of a

cra

ving

, lap

se,

or re

laps

e.

1 ye

ar, 1

0 m

onth

sA

t 36

wee

ks g

esta

tion

star

ted

calls

eve

ry 2

w

eeks

for t

he fi

rst 3

m

onth

s pos

tpar

tum

, the

n m

onth

ly fo

r the

last

3

mon

ths.

TABLE

4: C

ontin

ued

FIGURES AND TABLES


76

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Cum

min

s (20

16)

Wom

en w

ho c

alle

d qu

itlin

e re

ceiv

ed st

anda

rd se

lf-he

lp

mat

eria

ls

Enha

nced

qui

tline

tele

phon

e co

unse

ling

usin

g a

sem

i-stru

ctur

ed p

roto

col

deve

lope

d sp

ecifi

cally

for p

regn

ant s

mok

ers,

incl

udin

g pr

egna

ncy-

spec

ific

cont

ent a

nd n

ine

coun

selin

g se

ssio

ns. A

ll pa

rtici

pant

s als

o re

ceiv

ed a

self-

help

pa

cket

that

incl

uded

the A

CS’

s Mak

e You

rs a

Fre

sh S

tart

Fam

ily, f

act s

heet

s on

seco

ndha

nd sm

oke,

and

add

ition

al ti

ps fo

r qui

tting

whi

le p

regn

ant.

2 ye

ars,

20 m

onth

sB

asel

ine,

nea

r end

of

preg

nanc

y, a

nd 2

and

6

mon

ths p

ostp

artu

m

Eddy

(201

5)N

o co

mpa

rison

gro

upA

lthou

gh u

nder

taki

ng A

BC

is a

par

t of u

sual

mid

wife

ry p

ract

ice,

for t

he p

urpo

ses

of th

e pr

ojec

t hom

e-ba

sed

mid

wiv

es m

ade

disc

ussi

ons a

bout

smok

ing

a sp

ecifi

c fo

cus o

f the

ir ca

re, p

rovi

ding

AB

C n

ot o

nly

to a

ll pr

egna

nt a

nd p

ostn

atal

wom

en

in th

eir c

are

who

smok

ed, b

ut a

lso,

opp

ortu

nist

ical

ly, t

o ho

useh

old

mem

bers

, pa

rtner

s and

whā

nau.

2 ye

ars

At d

ate

of re

gist

ratio

n fo

r ca

re, e

ach

poin

t of c

are

Engl

and

(201

7)B

irth

reco

rds f

rom

bef

ore

natio

nal t

elev

isio

n sm

okin

g ce

ssat

ion

med

ia T

ips f

rom

Fo

rmer

Sm

oker

s (TI

PS)

Obs

erva

tiona

l stu

dy o

f pat

tern

s of s

mok

ing

cess

atio

n in

pre

gnan

t wom

en

befo

re a

nd a

fter T

ips c

ampa

ign

in In

dian

a, K

entu

cky

and

Ohi

o- 3

stat

es

with

out s

tate

smok

ing

cam

paig

ns, h

igh

rate

s of s

mok

ing,

that

wer

e in

the

Tips

ad

med

ia m

arke

t. Th

e ca

mpa

ign

aire

d fo

r 12

wee

ks M

arch

201

2- Ju

ne 2

012.

It

did

not c

onta

in p

regn

ancy

spec

ific

mes

sage

s. Th

e to

tal c

ampa

ign

dose

was

ap

prox

imat

ely

70%

hig

her t

han

the

natio

nal a

vera

ge d

ose

in O

hio

and

Ken

tuck

y an

d ap

prox

imat

ely

25%

hig

her i

n In

dian

a. It

is e

stim

ated

that

80%

of U

S ci

gare

tte sm

oker

s saw

at l

east

one

Tip

s 201

2 m

essa

ge a

nd th

at th

ose

who

saw

any

ad

verti

sem

ent a

vera

ged

23 v

iew

s ove

r the

12-

wee

k pe

riod.

4 ye

ars o

f dat

a an

alyz

ed

Dat

a co

llect

ion

of

repo

rted

preg

nant

smok

er

rate

s fro

m 2

009-

2013

Falli

n-B

enne

t (2

019)

No

com

paris

on g

roup

Tailo

red

and

impl

emen

ted

a pa

tient

nav

igat

or p

rogr

am to

toba

cco

treat

men

t am

ong

preg

nant

wom

en a

nd w

omen

in th

e ea

rly p

ostp

artu

m p

erio

d. T

he P

erin

atal

W

elln

ess N

avig

ator

(PW

N) p

rogr

am fi

lled

a ga

p in

serv

ices

by

prov

idin

g ev

iden

ce-b

ased

toba

cco

treat

men

t, as

wel

l as n

avig

atio

n (i.

e., c

ompr

ehen

sive

as

sess

men

t and

refe

rral

s to

clin

ical

and

soci

al se

rvic

es) t

o ad

dres

s bar

riers

and

pr

omot

e fa

cilit

ator

s to

smok

ing

cess

atio

n. In

terv

entio

n: O

ne o

n on

e de

liver

y of

Sm

okin

g C

essa

tion

and

Red

uctio

n in

Pre

gnan

cy T

reat

men

t (SC

RIP

T; W

inds

or e

t al

., 20

14),

an e

vide

nce-

base

d to

bacc

o tre

atm

ent c

urric

ulum

for p

regn

ant w

omen

. C

omm

unity

-bas

ed re

ferr

als f

or b

arrie

rs/is

sues

wom

en e

xper

ienc

ed (h

ousi

ng,

unem

ploy

men

t, re

latio

nshi

p is

sues

) and

for s

mok

ing

cess

atio

n gr

oups

wer

e pr

ovid

ed if

des

ired.

6 m

onth

sPr

enat

al in

terv

entio

n,

post

nata

l fol

low

up

at 3

m

onth

s

Forin

ash

(201

8)St

anda

rd o

f car

e fo

r pre

gnan

t sm

oker

sA

sses

sed

the

effe

ctiv

enes

s of s

mok

ing-

cess

atio

n te

xt m

essa

ging

whe

n ad

ded

to th

e st

anda

rd o

f car

e fo

r pre

gnan

t sm

oker

s at a

mat

erna

l fet

al c

are

cent

er. A

ll tri

al p

artic

ipan

ts re

ceiv

ed ro

utin

e st

anda

rd o

f car

e, w

hich

incl

uded

smok

ing

cess

atio

n co

unse

ling

and,

if in

tere

sted

, a v

isit

with

a c

linic

al p

harm

acis

t or

phar

mac

y re

side

nt a

nd, i

f app

ropr

iate

and

phy

sici

an c

lear

ed, n

icot

ine

repl

acem

ent

ther

apy.

In a

dditi

on to

the

rout

ine

stan

dard

of c

are,

the

inte

rven

tion

grou

p al

so

rece

ived

mot

ivat

iona

l mes

sage

s foc

used

on

smok

ing

cess

atio

n an

d pr

egna

ncy.

Th

e in

terv

entio

n gr

oup

rece

ived

text

mes

sage

s prio

r to,

dur

ing,

and

afte

r the

ir qu

it da

te, a

long

with

mes

sage

s rem

indi

ng th

em to

refil

l the

ir m

edic

atio

n. P

atie

nts

wer

e m

essa

ged

thro

ugh

Goo

d Vo

ice,

a sy

stem

requ

iring

a se

cure

logi

n an

d pa

ssw

ord.

2 ye

ars

At b

asel

ine/

qui

t dat

e, 2

w

eeks

afte

r qui

t dat

e, a

nd

follo

w u

p

TABLE

4: C

ontin

ued

FIGURES AND TABLES


77

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Glo

ver (

2016

)N

o co

mpa

rison

gro

upU

tiliz

ed a

Māo

ri vo

lunt

ary

com

mun

ity h

ealth

wor

kers

to id

entif

y an

d re

ach

Māo

ri pr

egna

nt w

omen

who

smok

e an

d pr

ovid

e ce

ssat

ion

supp

ort.

Thes

e “a

untie

s” fa

cilit

ated

acc

ess t

o N

RT, p

rovi

ded

supp

ort a

nd a

dvic

e, a

nd d

eliv

ered

em

otio

nal a

nd e

duca

tiona

l com

pone

nts.

Eigh

t Aun

ties w

ith a

Cer

tifica

te in

Māo

ri H

auor

a (M

āori

heal

th) w

ere

give

n so

me

addi

tiona

l tra

inin

g to

supp

ort s

mok

ing

cess

atio

n.

4 m

onth

sB

asel

ine

and

follo

w- u

p

Grif

fis (2

016)

Mat

ched

dem

ogra

phic

co

mpa

rison

with

wom

en

smok

ed in

firs

t trim

este

r

Hom

e vi

sito

rs in

Nur

se F

amily

Par

tner

ship

(NFP

), Pa

rent

s as T

each

ers (

PAT)

, H

ealth

y Fa

mili

es A

mer

ica

(HFA

), an

d Ea

rly H

ead

Star

t (EH

S) h

ome

visi

ting

prog

ram

supp

orte

d pr

egna

nt w

omen

s’ at

tem

pts t

o re

duce

and

qui

t sm

okin

g us

ing

Am

eric

an C

olle

ge o

f Obs

tetri

cian

s and

Gyn

ecol

ogis

ts’ (

AC

OG

) 5 A

’s

pren

atal

smok

ing

cess

atio

n ap

proa

ch a

nd th

e Sm

okin

g C

essa

tion

and

Red

uctio

n in

Pre

gnan

cy T

reat

men

t Met

hod

(SC

RIP

T) th

at u

se v

ario

us sm

okin

g ce

ssat

ion

inte

rven

tion

stra

tegi

es, i

nclu

ding

clie

nt e

duca

tion

of sm

okin

g ha

rms a

nd

cess

atio

n st

rate

gies

, mot

ivat

iona

l int

ervi

ewin

g, a

nd re

ferr

al to

out

side

pro

gram

s th

at o

ffer s

mok

ing

cess

atio

n co

unse

ling.

6 ye

ars

Hom

e vi

sitin

g en

rollm

ent,

third

tri

mes

ter i

nter

view

s

Han

kins

(201

6)N

on-s

mok

ing

preg

nant

wom

en

in th

e da

ta se

tsTo

est

imat

e th

e ef

fect

s of s

mok

ing

bans

on

neon

atal

hea

lth o

utco

mes

and

m

ater

nal s

mok

ing

beha

vior

dur

ing

preg

nanc

y, d

ata

on sm

okin

g ba

ns a

re li

nked

to

the

Nat

ality

Det

ail F

iles f

or th

e ye

ars 1

991–

2009

from

the

Nat

iona

l Cen

ter

for H

ealth

Sta

tistic

s, C

DC

wer

e an

alyz

ed. T

hese

dat

a co

ntai

n in

form

atio

n ab

out

both

the

mot

her a

nd th

e ba

by fo

r alm

ost e

very

birt

h in

the

Uni

ted

Stat

es. T

he fi

rst

data

set c

onta

ins a

ll si

ngle

ton

birth

s in

a co

unty

for w

hich

the

coun

ty o

f birt

h is

th

e sa

me

as th

e co

unty

whe

re th

e m

othe

r res

ides

. Thi

s res

trict

ion

acco

unts

for

the

maj

ority

of b

irths

and

sim

plifi

es th

e pr

oble

m o

f mot

hers

who

may

live

in a

co

unty

with

(with

out)

a sm

okin

g ba

n an

d w

ork

or d

ine

in a

cou

nty

with

out (

with

) a

smok

ing

ban.

The

seco

nd a

nd th

ird d

atas

ets a

re c

ompo

sed

of th

e sa

me

birth

s as

the

first

but

incl

ude

only

smok

ers o

r non

smok

ers,

resp

ectiv

ely.

18 y

ears

of d

ata

anal

yzed

A

t birt

h

Har

ris (2

015)

Web

-bas

ed C

ontin

genc

y m

anag

emen

t com

pare

d to

te

leph

one

coun

selin

g

Eval

uatio

n of

two

hom

e-ba

sed

smok

ing

cess

atio

n pr

ogra

ms.

One

of t

hese

pr

ogra

ms w

as a

n in

tens

ive

web

-bas

ed c

ontin

genc

y m

anag

emen

t (C

M) p

rogr

am

that

cou

ld b

e co

mpl

eted

from

hom

e. C

M-6

wee

k ph

ased

pro

gram

whe

re

parti

cipa

nts c

heck

ed in

twic

e pe

r day

with

bre

atha

lyze

rs (C

O2

leve

ls) p

rovi

ded

tang

ible

rein

forc

ers o

f inc

reas

ing

valu

e ov

er ti

me

for f

requ

ently

ver

ified

(tw

ice

per d

ay) a

bstin

ence

from

smok

ing

and

two

follo

w u

p sp

ot c

heck

s bef

ore

birth

. Th

e ot

her h

ome-

base

d tre

atm

ent p

rogr

am fo

r del

iver

y by

nur

ses o

ver t

he p

hone

5

times

and

follo

w u

p us

ing

a st

anda

rdiz

ed m

anua

l, of

a p

ilot p

rogr

am S

mok

ing

Ces

satio

n fo

r Hea

lthy

Birt

hs (S

CH

B) b

ased

on

AC

OG

gui

delin

es (5

A’s)

.

Not

stat

ed, b

efor

e 20

15Pr

etre

atm

ent a

sses

smen

ts

and

repe

ated

eac

h m

onth

of

pro

gram

, 2 fo

llow

up

s afte

r end

of 6

wee

k co

ntin

genc

y m

anag

emen

t pr

ogra

m b

ut b

efor

e bi

rth

Hav

ard

(201

8)N

o co

mpa

rison

gro

upEx

amin

atio

n of

the

impa

ct o

f ant

ism

okin

g ac

tiviti

es th

at b

egan

in 2

003

targ

etin

g th

e ge

nera

l pop

ulat

ion

and

an a

dver

tisin

g ca

mpa

ign

targ

etin

g sm

okin

g du

ring

preg

nanc

y on

the

prev

alen

ce o

f sm

okin

g du

ring

preg

nanc

y in

New

Sou

th W

ales

, A

ustra

lia.

8 ye

ars o

f dat

a an

alyz

edSm

okin

g pr

eval

ence

at

birth

TABLE

4: C

ontin

ued

FIGURES AND TABLES


78

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Jin

(201

8)C

ontro

l gro

up-p

hysi

cal a

ctiv

ity

with

out q

uit s

uppo

rtTh

e tre

atm

ent g

roup

rece

ived

mod

erat

e ex

erci

se 2

0 m

inut

es e

ach

sess

ion,

1

sess

ion

daily

, tw

ice

wee

kly,

for a

tota

l of 1

2 w

eeks

, in

addi

tion

to

indi

vidu

aliz

ed c

ogni

tive

beha

vior

al c

ouns

elin

g fo

r 30

min

utes

eac

h se

ssio

n,

once

dai

ly, t

wic

e w

eekl

y fo

r a to

tal o

f 12

wee

ks. T

he ta

ilore

d co

unse

ling

was

de

liver

ed b

y 3

prof

essi

onal

ly tr

aine

d he

alth

car

e ex

perts

and

incl

uded

a se

lf-he

lp

man

ual f

or su

bjec

ts to

qui

t sm

okin

g. T

he c

ouns

elin

g fo

llow

ed th

e “5

As”

(ask

, ad

vise

, ass

ess,

assi

st, a

rran

ge) f

rom

Am

eric

an C

olle

ge o

f Obs

tetri

cian

s and

G

ynec

olog

ists

reco

mm

enda

tions

. The

con

trol g

roup

was

ask

ed to

exe

rcis

e an

d di

d no

t rec

eive

the

coun

selin

g or

oth

er sm

okin

g ce

ssat

ion

supp

ort.

3 ye

ars,

4 m

onth

sEn

rollm

ent a

t 12-

14

wee

ks g

esta

tion,

at t

he

end

of tr

eatm

ent (

12

wee

ks),

at d

eliv

ery

Lee

(201

5)C

ontro

l gro

up re

ceiv

ed sm

okin

g ce

ssat

ion

stan

dard

of c

are

(5A’

s)C

ogni

tive

beha

vior

al c

ouns

elin

g (C

BC

) to

enha

nce

stan

dard

of c

are

smok

ing

cess

atio

n. P

artic

ipan

ts in

the

CB

C in

terv

entio

n m

et w

ith a

hea

lth e

duca

tor:

for 4

5 m

inut

es (s

essi

on 1

) dur

ing

thei

r sec

ond

trim

este

r vis

it (1

3–25

wee

ks

gest

atio

n); f

or 1

5 m

inut

es (s

essi

on 2

) dur

ing

thei

r thi

rd tr

imes

ter v

isit

(26–

38

wee

ks g

esta

tion)

; and

for 4

5 m

inut

es (s

essi

on 3

) dur

ing

the

first

pos

tpar

tum

vi

sit (

2–6

wee

ks p

ostp

artu

m).

Sess

ion

4 w

as a

boo

ster

sess

ion

deliv

ered

by

tele

phon

e at

8–1

0 w

eeks

pos

tpar

tum

for 1

5 m

in. T

he b

est p

ract

ice

(BP)

gro

up

(con

trol)

rece

ived

the

Clin

ical

Pra

ctic

e G

uide

line

for T

reat

ing

Toba

cco

Use

and

D

epen

denc

e -5

A’s b

ased

cou

nsel

ing

sess

ion

for 1

0–15

min

dur

ing

thei

r sec

ond

trim

este

r vis

it (s

essi

on 1

) and

rece

ived

gen

eric

qui

t sm

okin

g m

ater

ials

at t

he ti

me

of th

eir t

hird

trim

este

r vis

it (s

essi

on 2

). A

dditi

onal

ly, t

o eq

uate

for p

ostp

artu

m

atte

ntio

n, th

e B

P gr

oup

atte

nded

ano

ther

brie

f 5A’

s bas

ed c

ouns

elin

g se

ssio

n at

the

first

pos

tpar

tum

vis

it (s

essi

on 3

) and

rece

ived

a m

ailin

g of

an

educ

atio

n ne

wsl

ette

r as a

boo

ster

sess

ion

(ses

sion

4).

The

timin

g of

the

BP

cont

acts

was

de

sign

ed to

mat

ch th

e tim

ing

of th

e C

BC

’s p

rena

tal a

nd p

ostp

artu

m c

ouns

elin

g.

4 ye

ars,

4 m

onth

sEn

rollm

ent a

nd e

ach

sess

ion

from

firs

t tri

mes

ter t

o 5

mon

ths

post

par

tum

Lope

z (2

015a

) C

ontro

l gro

up re

ceiv

ed n

on-

cont

inge

nt in

cent

ives

con

trol

cond

ition

Wom

en w

ere

assi

gned

eith

er to

an

inte

rven

tion

whe

re th

ey e

arne

d vo

uche

rs

exch

ange

able

for r

etai

l ite

ms c

ontin

gent

on

abst

aini

ng fr

om sm

okin

g or

to a

co

ntro

l con

ditio

n w

here

they

rece

ived

vou

cher

s of c

ompa

rabl

e va

lue

inde

pend

ent

of sm

okin

g st

atus

. Vou

cher

s sta

rted

out a

t low

val

ue a

nd in

crea

sed

with

ver

ified

la

b re

sults

and

par

ticip

atin

g in

vis

its. I

f the

re w

ere

nega

tive

lab

resu

lts o

r mis

sed

visi

ts, t

he v

ouch

er v

alue

reve

rted

to th

e in

itial

low

val

ue. B

oth

grou

ps c

ontin

ued

to re

ceiv

e us

ual c

are

for s

mok

ing

cess

atio

n th

roug

h th

eir o

bste

trica

l ser

vice

s. W

omen

who

repo

rted

a pa

st h

isto

ry o

f dep

ress

ion

or h

ad c

urre

nt sy

mpt

oms

of d

epre

ssio

n on

stan

dard

scal

es a

t the

inta

ke a

sses

smen

t wer

e cl

assi

fied

as

depr

essi

on p

rone

(Dep

+). 2

7 W

omen

who

did

not

repo

rt a

past

his

tory

of

depr

essi

on a

nd w

ere

with

out c

urre

nt sy

mpt

oms o

f dep

ress

ion

wer

e cl

assi

fied

as d

epre

ssio

n ne

gativ

e (D

ep−)

. To

asse

ss th

e im

pact

of t

he in

terv

entio

n on

de

pres

sion

ratin

gs, w

e as

sess

ed th

e ef

fect

s of t

reat

men

t and

smok

ing

stat

us

at e

ach

asse

ssm

ent o

n de

pres

sion

scal

e sc

ores

, ind

ivid

ual s

cale

item

s, an

d th

e pr

opor

tion

of w

omen

mee

ting

eith

er o

f tw

o cu

t-offs

for p

ossi

ble

mild

or g

reat

er

or m

oder

ate

or g

reat

er c

linic

al d

epre

ssio

n

12 y

ears

of d

ata

anal

yzed

Ant

epar

tum

thro

ugh

12

wee

ks p

ostp

artu

m

TABLE

4: C

ontin

ued

FIGURES AND TABLES


79

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Lope

z (2

015b

)C

ontro

l gro

up re

ceiv

ed n

on-

cont

inge

nt in

cent

ives

con

trol

cond

ition

To u

nder

stan

d th

e ro

ll of

impu

lsiv

enes

s as a

risk

fact

or fo

r sub

stan

ce a

buse

di

sord

ers i

nclu

ding

toba

cco,

dat

a an

alys

is o

n ex

istin

g tri

als w

ere

cond

ucte

d in

two

step

s: F

irst,

asso

ciat

ions

bet

wee

n ba

selin

e im

puls

iven

ess s

core

s and

ab

stin

ence

at l

ate

preg

nanc

y an

d 24

-wee

ks p

ostp

artu

m a

s par

t of a

pla

nned

pr

ospe

ctiv

e st

udy

of th

is to

pic

usin

g da

ta fr

om a

rece

ntly

com

plet

ed, r

ando

miz

ed

cont

rolle

d cl

inic

al tr

ial (

N =

118

) wer

e ex

amin

ed. N

ext,

to in

crea

se st

atis

tical

po

wer

, a se

cond

ana

lysi

s was

con

duct

ed c

olla

psin

g re

sults

acr

oss t

hat r

ecen

t tri

al a

nd tw

o pr

ior t

rials

invo

lvin

g th

e sa

me

cont

inge

nt in

cent

ive

and

cont

rol

cond

ition

s (N

= 2

36).

Impu

lsiv

ity w

as a

sses

sed

usin

g a

dela

y di

scou

ntin

g (D

D)

of h

ypot

hetic

al m

onet

ary

rew

ards

task

in a

ll th

ree

trial

s and

Bar

ratt

Impu

lsiv

enes

s Sc

ale

(BIS

) in

the

mos

t rec

ent t

rial.

12 y

ears

of d

ata

anal

yzed

La

te p

regn

ancy

and

24

-wee

k po

stpa

rtum

7-

day

poin

t-pre

vale

nce

abst

inen

ce

Min

ian

(201

6)N

o co

mpa

rison

gro

upPr

even

tion

of G

esta

tiona

l and

Neo

nata

l Exp

osur

e to

Tob

acco

Sm

oke

(PR

EGN

ETS)

is a

n on

line

plat

form

supp

orte

d by

the

Cen

tre fo

r Add

ictio

n an

d M

enta

l Hea

lth to

pro

vide

supp

ort a

nd in

form

atio

nal r

esou

rces

to p

regn

ant a

nd

post

partu

m w

omen

and

thei

r hea

lth-c

are

prov

ider

s. In

an

effo

rt to

pro

vide

a m

ore

acce

ssib

le sp

ace

for u

sers

to c

onsu

me

and

exch

ange

info

rmat

ion,

PR

EGN

ETS

esta

blis

hed

a bl

og a

nd in

vite

d w

omen

with

the

lived

exp

erie

nce

of p

regn

ancy

an

d to

bacc

o us

e to

bec

ome

blog

gers

. Sev

en w

omen

par

ticip

ated

as b

logg

ers f

or

the

dura

tion

of 5

–10

mon

ths.

Blo

ggin

g re

spon

sibi

litie

s con

sist

ed o

f writ

ing

a bl

og p

ost a

ppro

xim

atel

y tw

ice

a m

onth

for a

five

-mon

th p

erio

d. B

logg

ers w

ere

enco

urag

ed to

writ

e re

flect

ion

piec

es a

bout

thei

r exp

erie

nces

with

smok

ing

and

preg

nanc

y, re

view

s of s

ervi

ces d

esig

ned

to a

ddre

ss th

eir n

eeds

, lis

ts to

sum

mar

ize

thei

r exp

erie

nces

or m

otiv

atio

ns, o

r per

sona

l let

ters

to e

xpre

ss th

eir f

eelin

gs

tow

ard

thei

r sup

port

netw

orks

. Blo

gger

s’ dr

afte

d bl

og p

osts

wou

ld u

nder

go

inte

rnal

revi

ew b

y PR

EGN

ETS

staf

f bef

ore

bein

g po

sted

to th

e PR

EGN

ETS

blog

av

aila

ble

to th

e pu

blic

. Com

pens

atio

n of

$65

.00

per p

ost w

ere

give

n

10 m

onth

sPo

st b

logg

ing

follo

w

up su

rvey

and

pho

ne

inte

rvie

w

Mor

gan

(201

6)N

o co

mpa

rison

gro

upIn

corp

orat

ion

of in

door

air

qual

ity (I

AQ

) mea

sure

men

ts in

to tw

o in

terv

entio

ns

for p

regn

ant w

omen

who

smok

e in

the

“Cle

aRIn

g th

e ai

r for

my

Bab

y: S

eein

g yo

ur sm

oke,

stop

ping

for y

our b

aby”

(“C

RIB

”) p

roje

ct in

Sco

tland

. One

was

in

Abe

rdee

n (“

CR

IB I”

) and

one

was

in C

oven

try (“

CR

IBC

OV

”). I

n A

berd

een,

w

omen

mad

e IA

Q m

easu

rem

ents

in th

eir h

omes

follo

win

g a

rout

ine

ultra

soun

d sc

an a

t aro

und

12 w

eeks

’ ges

tatio

n. In

Cov

entry

, IA

Q m

easu

rem

ents

wer

e ad

ded

to a

hom

e-ba

sed

Stop

Sm

okin

g in

Pre

gnan

cy S

ervi

ce. F

ollo

win

g pa

rtici

patio

n in

mak

ing

IAQ

mea

sure

men

ts, w

omen

wer

e in

vite

d to

und

erta

ke a

qua

litat

ive

inte

rvie

w.

9 m

onth

sEn

rollm

ent,

at IA

Q

afte

r12

wee

k ge

stat

iona

l ul

traso

und,

and

per

iod

hom

e-ba

sed,

pos

t par

tum

in

terv

iew

s

TABLE

4: C

ontin

ued

FIGURES AND TABLES


80

TABLE

4: C

ontin

ued

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Nau

ghto

n (2

017)

Con

trol g

roup

rece

ived

UK

N

HS

stan

dard

pre

nata

l sm

okin

g ce

ssat

ion

care

All

parti

cipa

nts r

ecei

ved

the

UK

Nat

iona

l Hea

lth S

ervi

ces (

NH

S) sm

okin

g ce

ssat

ion

leafl

et a

nd c

ontro

l par

ticip

ants

rece

ived

usu

al sm

okin

g ce

ssat

ion

care

. Int

erve

ntio

n pa

rtici

pant

s als

o re

ceiv

ed a

12-

wee

k pr

ogra

m o

f ind

ivid

ually

ta

ilore

d, a

utom

ated

, int

erac

tive,

self-

help

smok

ing

cess

atio

n te

xt m

essa

ges

(MiQ

uit).

MiQ

uit w

as a

n au

tom

ated

12-

wee

k ad

vice

and

supp

ort p

rogr

am

for q

uitti

ng sm

okin

g in

pre

gnan

cy d

eliv

ered

by

SMS

text

mes

sage

- Tai

lorin

g ch

arac

teris

tics i

nclu

de g

esta

tion,

mot

ivat

ion

to q

uit,

the

hard

est s

ituat

ion

to a

void

sm

okin

g, c

essa

tion

self-

effic

acy,

cig

aret

te d

epen

denc

e an

d pa

rtner

’s sm

okin

g st

atus

. ‘Pu

sh’ s

uppo

rt (i.

e. a

utom

ated

supp

ort s

ent t

o pa

rtici

pant

s’ ph

ones

) is

deliv

ered

acc

ordi

ng to

a d

eliv

ery

sche

dule

(0, 1

or 2

dai

ly te

xts)

. Pus

h m

essa

ge

freq

uenc

y is

hig

hest

in th

e fir

st 4

wee

ks. P

ush

supp

ort i

nclu

des m

otiv

atio

nal

mes

sage

s, ad

vice

abo

ut q

uit a

ttem

pt p

repa

ratio

n, m

anag

ing

crav

ings

and

w

ithdr

awal

, dea

ling

with

trig

ger s

ituat

ions

and

pre

vent

ing

laps

es, i

nfor

mat

ion

abou

t fet

al d

evel

opm

ent a

nd h

ow sm

okin

g af

fect

s thi

s. If

the

syst

em re

cord

ed 7

da

y se

lf-re

porte

d ab

stin

ence

this

was

ver

ified

bio

chem

ical

ly w

ith e

xhal

ed-b

reat

h ca

rbon

mon

oxid

e re

adin

gs a

nd/o

r sal

iva

sam

ples

test

ed fo

r cot

inin

e

7 m

onth

sB

asel

ine

data

at

enro

llmen

t; M

essa

ges

with

dat

a co

llect

ion

bega

n tw

o da

ys p

ost

enro

llmen

t and

last

ed

12 w

eeks

; sm

okin

g da

ta 4

wee

ks p

ost

rand

omiz

atio

n,

bioc

hem

ical

ver

ifica

tion

afte

r 7 d

ay se

lf-re

porte

d ab

stin

ence

Ola

iya

(201

5)C

ontro

l gro

up re

ceiv

ing

care

at

Wom

en, I

nfan

ts a

nd C

hild

ren

clin

ic (W

IC) w

hose

staf

f wer

e no

t tra

ined

in th

e 5A

’s sm

okin

g ce

ssat

ion

pack

age

Ass

esse

d if

smok

ing

cess

atio

n im

prov

ed a

mon

g pr

egna

nt sm

oker

s who

atte

nded

W

omen

, Inf

ants

and

Chi

ldre

n (W

IC) S

uppl

emen

tal N

utrit

ion

Prog

ram

clin

ics

train

ed to

impl

emen

t a b

rief s

mok

ing

cess

atio

n co

unse

ling

inte

rven

tion,

the

5As:

ask

, adv

ise,

ass

ess,

assi

st, a

rran

ge. I

n O

hio.

Sta

ff in

38

WIC

clin

ics w

ere

train

ed to

del

iver

the

5As f

rom

200

6 th

roug

h 20

10. U

sing

200

5–20

11 P

regn

ancy

N

utrit

ion

Surv

eilla

nce

Syst

em d

ata,

we

perf

orm

ed c

ondi

tiona

l log

istic

regr

essi

on,

stra

tified

on

clin

ic, t

o es

timat

e th

e re

latio

nshi

p be

twee

n w

omen

’s e

xpos

ure

to th

e 5A

s and

the

odds

of s

elf-

repo

rted

quitt

ing

durin

g pr

egna

ncy.

Rep

ortin

g bi

as fo

r qu

ittin

g w

as a

sses

sed

by e

xam

inin

g w

heth

er d

iffer

ence

s in

infa

nts’

birth

wei

ght

by q

uit s

tatu

s diff

ered

by

clin

ic tr

aini

ng st

atus

.

4 ye

ars o

f dat

a an

alyz

edPr

egna

ncy

Nut

ritio

n Su

rvei

llanc

e Sy

stem

da

ta-s

elf-

repo

rted

smok

ing

beha

vior

s th

ree

mon

ths p

rior t

o pr

egna

ncy,

at e

nrol

lmen

t in

WIC

and

last

thre

e m

onth

s of p

regn

ancy

Ols

on (2

019)

Con

trol g

roup

rece

ived

stan

dard

pr

enat

al sm

okin

g ce

ssat

ion

care

(5

A’s)

and

smal

l fee

for u

rine

test

ing

Test

the

effe

ctiv

enes

s of a

Sm

oke-

Free

Mom

s int

erve

ntio

n in

clud

ing

a se

ries

of fi

nanc

ial i

ncen

tives

for s

mok

ing

cess

atio

n w

hen

adde

d to

stan

dard

smok

ing

cess

atio

n pa

ckag

e. A

ll tri

al p

artic

ipan

ts re

ceiv

ed 5

As s

mok

ing

coun

selin

g fr

om

clin

ic st

aff.

At e

ach

clin

ic v

isit,

with

poi

nt-o

f-ca

re c

onfir

med

neg

ativ

e ur

inar

y co

tinin

e, w

omen

rece

ivin

g th

e in

terv

entio

n re

ceiv

ed a

$25

gift

car

d at

eac

h vi

sit.

Con

trol s

ubje

cts r

ecei

ved

$5 e

ach

visi

t for

test

ing

thei

r urin

e bu

t not

info

rmed

of

the

resu

lts. T

he la

tter d

id n

ot re

ceiv

e th

e gi

ft ca

rd.

3 ye

ars

Bas

elin

e at

firs

t pre

nata

l vi

sit,

each

subs

eque

nt

pren

atal

vis

it, 6

-8 w

eeks

po

stpa

rtum

Pass

ey (2

018)

No

com

paris

on g

roup

Ass

esse

d th

e fe

asib

ility

and

acc

epta

bilit

y of

impl

emen

ting

a cu

ltura

lly ta

ilore

d,

inte

nsiv

e sm

okin

g ce

ssat

ion

prog

ram

, inc

ludi

ng c

ontin

genc

y-ba

sed

finan

cial

re

war

ds (C

BFR

) cal

led

“Sto

p Sm

okin

g in

its T

rack

s”, f

or p

regn

ant A

borig

inal

w

omen

. The

stru

ctur

ed p

rogr

am in

clud

ed fr

eque

nt su

ppor

t with

indi

vidu

ally

ta

ilore

d co

unse

ling,

con

tract

to q

uit,

educ

atio

nal m

ater

ials

, fre

e ni

cotin

e re

plac

emen

t the

rapy

, inc

entiv

es, e

ngag

emen

t with

hou

seho

ld m

embe

rs, s

peci

ally

de

velo

ped

reso

urce

s, C

BFR

, and

pee

r sup

port

grou

ps.

2 ye

ars

Initi

al v

isit,

twic

e w

eekl

y fo

r 3 w

eeks

, onc

e w

eekl

y fo

r 4 w

eeks

, onc

e pe

r mon

th u

ntil

birth

po

stpa

rtum

FIGURES AND TABLES


81

TABLE

4: C

ontin

ued

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Patte

n (2

019)

Con

trol g

roup

rece

ived

usu

al

pren

atal

smok

ing

cess

atio

n ca

reTe

sted

the

effe

ctiv

enes

s of a

soci

al c

ogni

tive

theo

ry (S

CT)

-bas

ed b

iom

arke

r fe

edba

ck in

terv

entio

n fo

r sm

okin

g ce

ssat

ion

in p

regn

ant A

lask

an n

ativ

e w

omen

. The

con

trol g

roup

rece

ived

the A

K Q

uit T

obac

co P

rogr

am w

ith a

qui

t co

unse

lor.

The

inte

rven

tion

grou

p re

ceiv

ed th

eir b

iom

arke

r dat

a an

d m

otiv

atio

nal

inte

rvie

win

g fr

om q

uit c

ouns

elor

bas

ed o

n th

eir b

iom

arke

r/cot

inin

e le

vels

. The

qu

it co

unse

lor g

ave

risk

expo

sure

info

rmat

ion

and

rein

forc

ed b

ehav

ior c

hang

e by

di

scus

sing

how

smok

ing

cess

atio

n w

ould

redu

ce h

arm

ful c

onse

quen

ces.

1 ye

ar, 2

mon

ths

Bas

elin

e pr

ior t

o ra

ndom

izat

ion,

wee

k 5,

at

del

iver

y

Rey

nold

s (20

19)

Con

trol g

roup

rece

ived

cu

stom

ary

care

Eval

uate

d th

e fe

asib

ility

of a

n es

tabl

ishe

d be

havi

oral

inte

rven

tion

supp

orte

d by

on

goin

g on

line

info

rmat

ion,

whi

ch w

as c

usto

miz

ed fo

r pre

gnan

t wom

en a

nd

base

d on

cur

rent

evi

denc

e. T

he in

terv

entio

n gr

oup

rece

ived

cus

tom

ary

care

as

wel

l as a

20-

min

ute

coun

selin

g se

ssio

n at

firs

t ant

enat

al a

ppoi

ntm

ent,

follo

wed

by

acc

ess t

o a

smok

ing

cess

atio

n w

ebsi

te. T

he d

esig

n an

d de

liver

y of

the

inte

rven

tion

was

pro

vide

d by

a c

ertifi

ed sm

okin

g ce

ssat

ion

prac

titio

ner

2 ye

ars

Firs

t ant

enat

al

appo

intm

ent,

ante

nata

l vi

sits

, one

poi

nt in

tim

e su

rvey

Sloa

n (2

017)

No

com

paris

on g

roup

Sem

i-stru

ctur

ed in

terv

iew

s wer

e co

nduc

ted

with

15

wom

en fr

om a

larg

er R

CT

stud

y w

ho h

ad re

ceiv

ed th

e M

iQui

t int

erve

ntio

n du

ring

preg

nanc

y. W

omen

co

nsen

ted

to in

terv

iew

s whe

n as

ked

at th

eir fi

nal f

ollo

w-u

p fo

r the

larg

er st

udy

(up

to 3

8 w

eeks

ges

tatio

n af

ter a

12

wee

k te

xt m

essa

ging

pro

gram

).

Not

spec

ified

Ran

ge fr

om fi

nal w

eek

of

preg

nanc

y to

3 m

onth

s po

stpa

rtum

Stie

gler

(201

6)R

ando

miz

ed to

one

of t

hree

in

terv

entio

n gr

oups

Test

ed a

new

cou

nsel

ing

appr

oach

in th

e fo

rm o

f an

indi

vidu

aliz

ed, r

isk

adap

ted

inte

rnet

bas

ed in

terv

entio

n to

redu

ce a

lcoh

ol a

nd to

bacc

o co

nsum

ptio

n in

pr

egna

nt w

omen

(“IR

IS”)

, whi

ch is

an

anon

ymou

s int

erne

t-bas

ed c

ouns

elin

g pl

atfo

rm tr

iale

d fo

r a 1

2-w

eek

initi

ativ

e w

ith th

ree

diffe

rent

gro

ups:

1)

Toba

cco

cons

umin

g w

omen

rece

ived

not

onl

y ge

nera

l inf

orm

atio

n on

toba

cco

cons

umpt

ion

(psy

choe

duca

tion)

but

als

o th

e po

ssib

ility

of p

artic

ipat

ing

in a

ce

ssat

ion

prog

ram

bas

ed o

n “N

on-s

mok

er in

6 w

eeks

” w

hich

pla

ced

prim

ary

focu

s on

the

earli

est p

ossi

ble

cess

atio

n of

smok

ing;

2) W

omen

who

con

sum

ed

alco

hol d

urin

g pr

egna

ncy

wer

e gi

ven

the

oppo

rtuni

ty to

par

ticip

ate

in a

spec

ial

alco

hol c

ouns

elin

g pr

ogra

m w

ith in

form

ativ

e an

d ps

ycho

educ

ativ

e el

emen

ts o

n im

med

iate

ces

satio

n of

alc

ohol

con

sum

ptio

n an

d co

nsul

tatio

n w

ith a

med

ical

sp

ecia

list;

and

3) W

omen

with

alc

ohol

and

toba

cco

cons

umpt

ion

rece

ived

acc

ess

to a

com

bine

d pr

ogra

m u

nitin

g th

e el

emen

ts o

f bot

h in

itiat

ives

. All

prog

ram

s w

ere

deliv

ered

thro

ugh

an o

nlin

e pl

atfo

rm

2 ye

ars

Bas

elin

e/en

rolm

ent,

10 w

eeks

afte

r sta

rt of

pr

ogra

m

FIGURES AND TABLES


82

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Tapp

in (2

015)

Con

trol g

roup

rece

ived

usu

al

pren

atal

smok

ing

cess

atio

n an

d ob

stet

rical

car

e

To a

sses

s acc

epta

bilit

y an

d ex

plor

e ef

ficac

y an

d co

st e

ffect

iven

ess o

f up

to £

400

of sh

oppi

ng v

ouch

ers a

dded

to ro

utin

e sp

ecia

list p

regn

ancy

Nat

iona

l Hea

lth

Serv

ice

“Sto

p Sm

okin

g Se

rvic

es”.

The

con

trol g

roup

rece

ived

rout

ine

care

, whi

ch

was

the

offe

r of a

face

to fa

ce a

ppoi

ntm

ent t

o di

scus

s sm

okin

g an

d ce

ssat

ion

and,

fo

r tho

se w

ho a

ttend

ed a

nd se

t a q

uit d

ate,

the

offe

r of f

ree

nico

tine

repl

acem

ent

ther

apy

for 1

0 w

eeks

pro

vide

d by

pha

rmac

y se

rvic

es, a

nd fo

ur, w

eekl

y su

ppor

t ph

one

calls

. The

inte

rven

tion

grou

p re

ceiv

ed ro

utin

e ca

re p

lus t

he o

ffer o

f up

to £

400

of sh

oppi

ng v

ouch

ers:

£50

for a

ttend

ing

a fa

ce to

face

app

oint

men

t an

d se

tting

a q

uit d

ate;

ano

ther

£50

if a

t fou

r wee

ks’ p

ost-q

uit d

ate

exha

led

carb

on m

onox

ide

confi

rmed

qui

tting

; a fu

rther

£10

0 w

as p

rovi

ded

for c

ontin

ued

valid

ated

abs

tinen

ce o

f exh

aled

car

bon

mon

oxid

e af

ter 1

2 w

eeks

; and

a fi

nal

£200

vou

cher

was

pro

vide

d fo

r val

idat

ed a

bstin

ence

of e

xhal

ed c

arbo

n m

onox

ide

at 3

4-38

wee

ks’ g

esta

tion.

1 ye

ar, 2

mon

ths

Firs

t pre

nata

l vis

it an

d ea

ch p

rena

tal /

follo

w-u

p vi

sit t

hrou

gh 6

mon

ths

post

partu

m

Uss

her (

2015

a)C

ontro

l gro

up re

ceiv

ed

beha

vior

al sm

okin

g ce

ssat

ion

supp

ort o

nly

Com

pare

d si

x w

eekl

y se

ssio

ns o

f 20

min

utes

of i

ndiv

idua

l beh

avio

ral c

essa

tion

supp

ort,

star

ting

one

wee

k be

fore

the

quit

date

with

beh

avio

ral s

uppo

rt pl

us a

n ex

erci

se in

terv

entio

n. A

t enr

ollm

ent p

artic

ipan

ts w

ere

rand

omiz

ed to

beh

avio

ral

cess

atio

n su

ppor

t alo

ne o

r to

beha

vior

al c

essa

tion

supp

ort p

lus a

phy

sica

l act

ivity

in

terv

entio

n, c

ombi

ning

supe

rvis

ed e

xerc

ise

with

phy

sica

l act

ivity

con

sulta

tions

. Fo

urte

en se

ssio

ns o

f sup

ervi

sed

exer

cise

wer

e of

fere

d ov

er e

ight

wee

ks; t

wic

e a

wee

k fo

r six

wee

ks, t

hen

wee

kly

for t

wo

wee

ks. A

t eac

h se

ssio

n, th

e pa

rtici

pant

s w

alke

d at

a m

oder

ate

inte

nsity

on

a tre

adm

ill fo

r up

to 3

0 m

inut

es. I

mm

edia

tely

be

fore

eac

h tre

adm

ill se

ssio

n, th

e w

omen

rece

ived

beh

avio

ral s

uppo

rt. A

t the

fir

st tw

o tre

adm

ill se

ssio

ns, a

nd th

en o

n ev

ery

othe

r occ

asio

n (to

tal o

f nin

e co

nsul

tatio

ns),

this

supp

ort a

imed

to id

entif

y op

portu

nitie

s to

inco

rpor

ate

phys

ical

act

ivity

into

wom

en’s

live

s, to

mot

ivat

e th

em to

use

phy

sica

l act

ivity

to

redu

ce th

e ur

ge to

smok

e, a

nd to

hel

p th

em u

se b

ehav

iora

l stra

tegi

es to

impr

ove

adhe

renc

e to

thes

e pl

ans.

3 ye

ars

Bas

elin

e, 1

wee

k, 4

w

eeks

, 6 w

eeks

; end

of

preg

nanc

y; a

nd te

leph

one

follo

w-u

p 6

mon

ths

post

nata

lly

Uss

her (

2015

b)C

ontro

l gro

up re

ceiv

ed

beha

vior

al sm

okin

g ce

ssat

ion

supp

ort o

nly

The

Lond

on E

xerc

ise A

nd P

regn

ant s

mok

ers (

LEA

P) tr

ial w

as c

ondu

cted

to

asse

ss th

e ef

fect

iven

ess a

nd c

ost-e

ffect

iven

ess o

f a p

hysi

cal a

ctiv

ity in

terv

entio

n fo

r sm

okin

g ce

ssat

ion

durin

g pr

egna

ncy.

The

mai

n ob

ject

ive

was

to in

vest

igat

e w

heth

er o

r not

beh

avio

ral s

uppo

rt fo

r sm

okin

g ce

ssat

ion

plus

a p

hysi

cal a

ctiv

ity

inte

rven

tion

is m

ore

effe

ctiv

e re

lativ

e to

beh

avio

ral s

uppo

rt al

one

for a

chie

ving

bi

oche

mic

ally

val

idat

ed sm

okin

g ce

ssat

ion

betw

een

a qu

it da

te a

nd e

nd o

f pr

egna

ncy.

For

the

LEA

P tri

al, p

artic

ipan

ts w

ere

rand

omiz

ed to

beh

avio

ral

supp

ort f

or sm

okin

g ce

ssat

ion

(con

trol)

or b

ehav

iora

l sup

port

+ a

phys

ical

ac

tivity

inte

rven

tion

cons

istin

g of

supe

rvis

ed tr

eadm

ill e

xerc

ise

+ ph

ysic

al

activ

ity c

onsu

ltatio

ns. N

eith

er p

artic

ipan

ts n

or re

sear

cher

s wer

e bl

inde

d to

tre

atm

ent a

lloca

tion.

Ano

ther

obj

ectiv

e w

as to

ass

ess t

he c

ost-e

ffect

iven

ess o

f the

in

terv

entio

n fo

r ach

ievi

ng sm

okin

g ce

ssat

ion

at th

e en

d of

pre

gnan

cy.

3 ye

ars

Bas

elin

e, 1

wee

k, 4

w

eeks

, 6 w

eeks

; end

of

preg

nanc

y; a

nd te

leph

one

follo

w-u

p 6

mon

ths

post

nata

lly

TABLE

4: C

ontin

ued

FIGURES AND TABLES


83

STU

DY

CO

MPA

RISO

N G

ROU

PD

ESC

RIPT

ION

OF

INTE

RVEN

TIO

NST

UD

Y LE

NG

THD

ATA

CO

LLEC

TIO

N

Wen

(201

9)N

o co

mpa

rison

gro

upA

non

-con

curr

ent,

mul

tiple

-bas

elin

e (a

cros

s par

ticip

ants

) des

ign

was

use

d to

is

olat

e in

terv

entio

n ef

fect

s fro

m th

e im

pact

of a

ttent

ion

and

time

with

par

ticip

ants

se

rvin

g as

thei

r ow

n co

ntro

ls. I

nter

vent

ion

for s

mok

ing

cess

atio

n in

itiat

ed la

ter

in e

nrol

lmen

t usi

ng re

peat

ed b

asel

ine

to u

nder

stan

d sm

okin

g le

vel-

parti

cipa

nts

assi

gned

to o

ne o

f thr

ee g

roup

s with

diff

eren

t dur

atio

ns o

f the

repe

ated

bas

elin

e:

early

inte

rven

tion

(abo

ut 1

wee

k), d

elay

ed in

terv

entio

n (a

bout

2 w

eeks

), or

late

in

terv

entio

n (a

bout

3 w

eeks

). A

fter t

he a

ssig

ned

base

line

perio

d w

as c

ompl

eted

an

d a

fairl

y st

able

smok

ing

leve

l was

ach

ieve

d, a

ll pa

rtici

pant

s rec

eive

d th

e sa

me

mul

ticom

pone

nt b

ehav

iora

l int

erve

ntio

n. T

he in

terv

entio

n w

as 8

wee

ks lo

ng.

Parti

cipa

nts c

hose

a q

uit d

ate

with

in th

e ne

xt 1

4 da

ys a

nd si

gned

a sm

oke-

free

pl

edge

and

a q

uitti

ng c

ontra

ct. A

tota

l of 2

2 su

bseq

uent

inte

rven

tion

visi

ts w

ere

sche

dule

d af

ter t

he q

uit d

ate.

Pre

gnan

t wom

en w

ere

supp

osed

to m

eet w

ith a

sm

okin

g ce

ssat

ion

coun

selo

r dai

ly (M

onda

y to

Frid

ay) f

or 2

wee

ks a

nd th

en

twic

e a

wee

k w

ith a

t lea

st a

2-d

ay in

terv

al b

etw

een

visi

ts fo

r ano

ther

6 w

eeks

. Th

e av

erag

e le

ngth

of e

ach

inte

rven

tion

visi

t was

abo

ut 1

hr.

The

stag

es o

f be

havi

oral

inte

rven

tion

cons

iste

d of

four

inte

grat

ed c

ompo

nent

s: st

age-

tailo

red

educ

atio

n an

d co

unse

ling,

smok

ing

mon

itorin

g an

d fe

edba

ck, c

ontin

gent

fina

ncia

l in

cent

ives

, and

fam

ily su

ppor

t.

1 ye

ar, 4

mon

ths

Enro

llmen

t pre

test

vis

it,

varie

d ba

selin

e 1,

2, o

r 3

wee

ks p

ost p

rete

st),

8 w

eeks

pos

t-tes

t vis

it

Zvor

sky

(201

5)C

ontro

l gro

up th

at re

ceiv

ed

finan

cial

ince

ntiv

es in

depe

nden

t of

smok

ing

stat

us

Ana

lysi

s of f

our c

ontro

lled

clin

ical

tria

ls o

n th

e ef

ficac

y of

fina

ncia

l inc

entiv

es

for s

mok

ing

cess

atio

n to

det

erm

ine

whe

ther

pre

gnan

t and

new

ly p

ostp

artu

m

smok

ers a

t ris

k fo

r pos

tpar

tum

dep

ress

ion

resp

ond

to a

n in

cent

ive-

base

d sm

okin

g-ce

ssat

ion

treat

men

t and

how

the

inte

rven

tion

impa

cts d

epre

ssio

n ra

tings

. Wom

en w

ere

assi

gned

eith

er to

an

inte

rven

tion

whe

rein

they

ear

ned

vouc

hers

exc

hang

eabl

e fo

r ret

ail p

rodu

cts c

ontin

gent

on

abst

aini

ng fr

om sm

okin

g or

to a

con

trol c

ondi

tion

whe

rein

they

rece

ived

vou

cher

s of c

ompa

rabl

e va

lue

inde

pend

ent o

f sm

okin

g st

atus

. Dep

ress

ion

ratin

gs w

ere

appl

ied

ante

partu

m a

nd

post

partu

m, a

cros

s 7 a

sses

smen

ts.

12 y

ears

of d

ata

anal

yzed

In

itial

pre

nata

l vis

it, e

ach

pren

atal

vis

it, p

ostp

artu

m

follo

w u

p vi

sit

TABLE

4: C

ontin

ued

FIGURES AND TABLES


84

TABLE

5: D

ATA

SO

URC

ES A

ND

OU

TCO

MES

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Abr

oms (

2017

a)Su

rvey

s and

saliv

a sa

mpl

ePr

ogra

m a

ccep

tabi

lity

and

feas

ibili

ty; U

se o

f tre

atm

ents

and

reso

urce

s;

Smok

ing-

rela

ted

outc

omes

–

abst

inen

ce, c

onse

cutiv

e da

ys

quit,

24-

hour

qui

t atte

mpt

s, ci

gare

ttes s

mok

er p

er d

ay,

self-

effic

acy

Res

ults

indi

cate

that

Sm

okef

reeM

OM

was

rate

d hi

ghly

and

mor

e fa

vora

bly

than

a c

ontro

l co

nditi

on th

at c

onsi

sted

of a

sing

le te

xt m

essa

ge in

its h

elpf

ulne

ss a

t 3-m

onth

follo

w-u

p an

d in

its f

requ

ency

of m

essa

ging

at b

oth

time

poin

ts. A

mon

g th

e in

terv

entio

n gr

oup

parti

cipa

nts,

mes

sage

s wer

e re

ad a

t hig

h ra

tes a

nd p

artic

ipan

ts u

nsub

scrib

ed fr

om th

e pr

ogra

m a

t low

ra

tes.

Non

ethe

less

, alm

ost 3

0% o

f par

ticip

ants

exp

erie

nced

som

e te

chni

cal p

robl

ems w

ith th

e pr

ogra

m d

urin

g th

e st

udy

perio

d, la

rgel

y re

late

d to

not

bei

ng a

ble

to g

et re

spon

ses f

rom

the

auto

mat

ed sy

stem

afte

r rep

lyin

g to

que

ries o

r sen

ding

in k

eyw

ords

. The

re w

ere

no si

gnifi

cant

di

ffere

nces

bet

wee

n gr

oups

on

use

of e

xtra

trea

tmen

t res

ourc

es o

r on

smok

ing-

rela

ted

outc

omes

, tho

ugh

som

e ou

tcom

es fa

vore

d th

e in

terv

entio

n gr

oup

at 3

-mon

th fo

llow

-up.

Som

e pa

rtici

pant

s fel

t the

pro

gram

was

a tr

igge

r for

smok

ing.

Abr

oms (

2017

b)Su

rvey

s and

saliv

a sa

mpl

ePo

int p

reva

lenc

e ab

stin

ence

(P

PA) d

urin

g pr

egna

ncy

and

post

-par

tum

con

firm

ed

bioc

hem

ical

ly a

nd b

y se

lf-re

port

For t

he p

rimar

y ou

tcom

e, b

ioch

emic

ally

con

firm

ed 7

-day

PPA

at t

he 3

-mon

th fo

llow

-up,

ther

e w

as n

o ov

eral

l effe

ct o

f the

inte

rven

tion,

alth

ough

effe

cts w

ere

foun

d am

ong

two

subg

roup

s:

thos

e w

ho e

nrol

led

in th

e st

udy

in th

eir s

econ

d or

third

trim

este

r and

thos

e w

ho w

ere

aged

≥2

6 ye

ars.

Add

ition

ally

, for

seco

ndar

y ou

tcom

es b

ased

on

self-

repo

rt, a

n ef

fect

of Q

uit4

baby

on

7-d

ay P

PA a

t 1 a

nd 3

mon

ths a

nd in

late

pre

gnan

cy w

as o

bser

ved.

How

ever

, no

effe

cts

wer

e ob

serv

ed o

n se

lf-re

porte

d 7-

day

PPA

at 6

mon

ths o

r in

the

post

partu

m p

erio

d. R

esul

ts

prov

ide

limite

d su

ppor

t of t

he e

ffica

cy o

f the

Qui

t4ba

by te

xt m

essa

ging

pro

gram

in th

e sh

ort

term

and

late

in p

regn

ancy

, but

not

in th

e po

stpa

rtum

per

iod.

Abr

oms (

2015

)Te

leph

one

surv

eys,

retro

spec

tive

com

pute

r rec

ords

revi

ew o

f en

gage

men

t with

the

tech

nolo

gy

Prog

ram

acc

epta

bilit

y an

d fe

asib

ility

; sm

okin

g re

duct

ion

or c

essa

tion

The

pilo

t tes

t pro

vide

s sup

port

for t

he fe

asib

ility

and

acc

epta

bilit

y of

Qui

t4ba

by. P

artic

ipan

ts

gave

ove

rall

high

ratin

gs to

the

Qui

t4ba

by te

xt-m

essa

ging

pro

gram

. Par

ticip

ants

agr

eed

that

th

e pr

ogra

m w

as h

elpf

ul in

qui

tting

, gav

e go

od id

eas o

n qu

ittin

g, a

nd th

ey w

ould

reco

mm

end

the

prog

ram

to a

frie

nd. A

t bas

elin

e, p

artic

ipan

ts sm

oked

an

aver

age

of 7

.6 c

igar

ette

s per

day

. A

t the

2-w

eek

follo

w-u

p, th

e av

erag

e nu

mbe

r of c

igar

ette

s sm

oked

had

dec

reas

ed to

4.7

. At

the

4-w

eek

follo

w-u

p, th

is n

umbe

r had

dec

reas

ed to

2.4

cig

aret

tes p

er d

ay. A

t the

2-w

eek-

follo

w-u

p, 5

par

ticip

ants

out

of 1

3 (3

8%) h

ad re

porte

d ab

stai

ning

for t

he p

ast w

eek,

and

7

parti

cipa

nts o

ut o

f 13

(54%

) rep

orte

d ab

stai

ning

for t

he p

ast w

eek

at th

e 4-

wee

k fo

llow

-up.

Bai

ley,

S.R

. (20

17)

Elec

troni

c he

alth

reco

rds

Rat

e of

rece

ivin

g st

anda

rd

smok

ing

cess

atio

n in

terv

entio

ns; r

ate

of

smok

ing

cess

atio

n

Non

-pre

gnan

t pat

ient

s had

dec

reas

ed o

dds o

f cur

rent

smok

ing

over

tim

e; o

dds f

or a

ll ot

her

outc

omes

incr

ease

d ex

cept

for m

edic

atio

n or

ders

from

201

0 to

201

2. A

mon

g pr

egna

nt

patie

nts,

odds

of a

sses

smen

t and

cou

nsel

ing

incr

ease

d ac

ross

all

year

s. O

dds o

f dis

cuss

ing

or o

rder

ing

cess

atio

n m

edic

atio

ns in

crea

sed

from

201

0 co

mpa

red

with

the

othe

r 2 st

udy

year

s; h

owev

er, m

edic

atio

n or

ders

did

not

cha

nge

over

tim

e, a

nd c

urre

nt sm

okin

g on

ly

decr

ease

d fr

om 2

010

to 2

012.

Tho

ugh

the

over

all d

ecre

ase

in c

urre

nt sm

okin

g w

as sm

all,

30.3

% in

201

0 ve

rsus

27.

2% in

201

4, g

iven

the

publ

ic h

ealth

care

cos

ts a

nd c

omor

bidi

ties

asso

ciat

ed w

ith sm

okin

g, th

is c

hang

e is

hig

hly

sign

ifica

nt fr

om a

pub

lic h

ealth

per

spec

tive.

C

urre

nt sm

okin

g di

d no

t dec

reas

e ov

er ti

me,

des

pite

the

incr

ease

in re

ceip

t of c

ouns

elin

g.

Giv

en th

at m

edic

atio

n pl

us c

ouns

elin

g su

bsta

ntia

lly in

crea

ses c

essa

tion

rate

s com

pare

d w

ith

coun

selin

g al

one

and

only

a li

ttle

mor

e th

an h

alf o

f pre

gnan

t wom

en re

ceiv

ed c

ouns

elin

g, th

e in

sign

ifica

nt c

hang

e in

smok

ing

rate

s is n

ot su

rpris

ing,

alb

eit i

t is c

once

rnin

g.

FIGURES AND TABLES


85

TABLE

5: C

ontin

ued

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Bai

ley,

B.A

. (20

15)

Self-

repo

rt of

smok

ing

beha

vior

, ex

hale

d C

O, u

rine

cotin

ine

Bio

chem

ical

ly v

erifi

ed q

uit

rate

Of t

hose

offe

red

the

inte

rven

tion,

28.

1% q

uit s

mok

ing

by th

e en

d of

the

seco

nd tr

imes

ter

and

rem

aine

d sm

okin

g-fr

ee to

del

iver

y as

ver

ified

bio

chem

ical

ly. I

n co

ntra

st, o

nly

9.8%

of

the

cont

rol g

roup

, who

rece

ived

usu

al c

are

only

, qui

t sm

okin

g pr

ior t

o th

e th

ird tr

imes

ter a

nd

rem

aine

d sm

okin

g fr

ee to

del

iver

y. B

irth

outc

omes

als

o sh

owed

pos

itive

out

com

es c

ompa

red

to c

ontro

ls.

Hav

ing

educ

ated

hea

lth e

duca

tors

with

kno

wle

dge

of so

cial

nee

ds w

as im

porta

nt

to o

utco

mes

and

incr

ease

d us

age

of p

rena

tal s

ervi

ces.

Bar

thol

omew

(201

6)W

V V

ital s

tatis

tics d

ata

Pren

atal

smok

ing

beha

vior

s an

d bi

rth o

utco

mes

Non

e of

the

regu

latio

ns h

ad a

ny e

ffect

on

pren

atal

smok

ing

in th

e fu

ll sa

mpl

e. P

rena

tal

smok

ing

show

ed v

ery

limite

d ef

fect

, with

a sm

all d

ecre

ase

in m

arrie

d w

omen

with

the

mor

e co

mpr

ehen

sive

smok

e fr

ee re

gula

tions

. With

rega

rd to

birt

h ou

tcom

es, o

nly

mor

e co

mpr

ehen

sive

smok

e fr

ee re

gula

tions

wer

e as

soci

ated

with

stat

istic

ally

sign

ifica

nt fa

vora

ble

effe

cts o

n bi

rth o

utco

mes

in th

e fu

ll sa

mpl

e: C

ompr

ehen

sive

(wor

kpla

ce/re

stau

rant

/bar

ban

) de

mon

stra

ted

incr

ease

d bi

rthw

eigh

t and

pre

term

birt

h. R

estri

ctiv

e (w

orkp

lace

/rest

aura

nt b

an)

dem

onst

rate

d a

smal

l dec

reas

e in

ver

y lo

w b

irthw

eigh

t. A

mon

g le

ss re

stric

tive

regu

latio

ns:

Mod

erat

e (w

orkp

lace

ban

) was

ass

ocia

ted

with

a 2

3g d

ecre

ase

in b

irthw

eigh

t; Li

mite

d (p

artia

l ba

n) h

ad n

o ef

fect

. Com

preh

ensi

ve’s

impr

ovem

ents

ext

ende

d to

mos

t mat

erna

l gro

ups,

and

wer

e br

oade

st a

mon

g m

othe

rs 2

1+ y

ears

, non

-sm

oker

s, an

d un

mar

ried

mot

hers

. Reg

ulat

ion

rest

rictiv

enes

s is a

det

erm

inin

g fa

ctor

in th

e im

pact

of s

mok

e fr

ee re

gula

tions

on

birth

ou

tcom

es, w

ith c

ompr

ehen

sive

smok

e fr

ee re

gula

tions

show

ing

prom

ise

in im

prov

ing

birth

ou

tcom

es. F

avor

able

effe

cts o

n bi

rth o

utco

mes

app

ear t

o st

em fr

om re

duce

d se

cond

han

d sm

oke

expo

sure

rath

er th

an re

duce

d pr

enat

al sm

okin

g pr

eval

ence

.

Bel

l (20

18)

Elec

troni

c he

alth

reco

rds

Smok

ing

Ces

satio

n, m

ater

nal

heal

th a

nd c

ost/b

enefi

tTh

e in

trodu

ctio

n of

a sy

stem

-wid

e in

terv

entio

n to

pro

mot

e sm

okin

g ce

ssat

ion

durin

g pr

egna

ncy

incr

ease

d re

ferr

als t

o sm

okin

g ce

ssat

ion

by 2

.5 ti

mes

and

the

prop

ortio

n of

wom

en

quitt

ing

by d

eliv

ery

by n

early

twof

old.

Qui

tting

smok

ing

durin

g pr

egna

ncy

was

ass

ocia

ted

with

a c

linic

ally

impo

rtant

incr

ease

in b

irth

wei

ght.

The

refe

rral

rate

incr

ease

d pr

ogre

ssiv

ely

in th

e fir

st 3

mon

ths a

fter t

he in

terv

entio

n w

as in

trodu

ced.

The

inte

rven

tion

was

ass

ocia

ted

with

a si

gnifi

cant

incr

ease

in re

ferr

als.

Add

ition

al tr

aini

ng se

ssio

ns w

ere

asso

ciat

ed w

ith

an in

crea

se in

refe

rral

s in

the

mon

th o

f, as

was

ava

ilabi

lity

of a

syst

em fo

r enh

ance

d in

itial

co

ntac

t with

smok

ers.

Intro

duct

ion

of th

e in

terv

entio

n w

as a

ssoc

iate

d w

ith a

sign

ifica

nt

incr

ease

in q

uitti

ng b

y de

liver

y. T

he o

dds o

f qui

tting

wer

e hi

gher

) for

del

iver

ies w

ith a

re

cord

ed re

ferr

al to

smok

ing

cess

atio

n se

rvic

es, a

nd if

ther

e w

as a

reco

rd o

f a q

uit d

ate.

The

od

ds o

f qui

tting

wer

e si

gnifi

cant

ly h

ighe

r fol

low

ing

addi

tiona

l tra

inin

g. M

othe

rs re

side

nt in

th

e m

ost d

epriv

ed a

reas

wer

e le

ss li

kely

to q

uit a

s wer

e yo

unge

r mot

hers

and

thos

e of

whi

te

ethn

icity

. A

dditi

onal

find

ings

: Bab

ies b

orn

to w

omen

who

did

not

smok

e du

ring

preg

nanc

y w

ere

sign

ifica

ntly

hea

vier

than

thos

e bo

rn to

wom

en w

ho sm

oked

thro

ugho

ut p

regn

ancy

and

th

e in

crem

enta

l cos

t per

add

ition

al q

uitte

r was

£95

2 an

d th

e nu

mbe

r nee

ded

to tr

eat f

or e

ach

addi

tiona

l qui

tter w

as 3

1 pr

egna

nt w

omen

.

FIGURES AND TABLES


86

TABLE

5: C

ontin

ued

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Ber

lin (2

014)

Saliv

a co

tinin

e, b

irth

reco

rds

Abs

tinen

ce ra

tes;

cra

ving

fo

r tob

acco

, with

draw

al

sym

ptom

s, nu

mbe

r of

ciga

rette

s sm

oked

, mat

erna

l bl

ood

pres

sure

, birt

h w

eigh

t

The

nico

tine

patc

h di

d no

t inc

reas

e ei

ther

smok

ing

cess

atio

n ra

tes o

r birt

h w

eigh

ts d

espi

te

adju

stm

ent o

f nic

otin

e do

se to

mat

ch le

vels

atta

ined

whe

n sm

okin

g, a

nd h

ighe

r tha

n us

ual

dose

s. E

ven

a re

lativ

ely

high

dai

ly d

ose

of n

icot

ine,

adj

uste

d fo

r bas

elin

e sa

liva

cotin

ine

leve

ls a

nd a

dmin

iste

red

with

a re

lativ

ely

high

self-

repo

rted

com

plia

nce

rate

for a

med

ian

of 1

05 d

ays d

urin

g th

e se

cond

and

third

trim

este

r did

not

incr

ease

abs

tinen

ce ra

tes.

The

com

plet

e ab

stin

ence

rate

from

qui

t dat

e up

to e

nd o

f pre

gnan

cy w

as lo

w (5

.5%

and

5.1

%),

and

this

was

low

er th

an th

e 21

% a

nd 1

9% (r

elat

ive

risk

1.1%

, 95%

con

fiden

ce in

terv

al 0

.7%

to

1.8

%) f

ound

in th

e m

ost s

imila

rly d

esig

ned

prev

ious

stud

y, b

ut w

ith a

subs

tant

ially

shor

ter

expo

sure

. The

nic

otin

e su

bstit

utio

n ra

te in

the

nico

tine

patc

h gr

oup

show

ed th

at a

bstin

ence

w

as u

nrel

ated

to th

e le

vel o

f nic

otin

e su

bstit

utio

n, su

gges

ting

that

fact

ors o

ther

than

nic

otin

e re

plac

emen

t may

det

erm

ine

abst

inen

ce in

pre

gnan

t sm

oker

s. T

he n

icot

ine

patc

h di

d no

t si

gnifi

cant

ly re

duce

cra

ving

for t

obac

co, w

ithdr

awal

sym

ptom

s, or

num

ber o

f cig

aret

tes

smok

ed. D

iast

olic

blo

od p

ress

ure

incr

ease

d si

gnifi

cant

ly in

the

nico

tine

patc

h gr

oup

com

pare

d w

ith p

lace

bo p

atch

gro

up.

Bro

wn

(201

6)N

atio

nal S

urve

y of

Dru

g U

se a

nd

Hea

lth (N

SDU

H) 2

010-

2013

Rel

atio

nshi

p be

twee

n he

alth

in

sura

nce

and

toba

cco

use

in

1st, 2

nd, a

nd 3

rd tr

imes

ter

Am

ong

preg

nant

wom

en th

ere

wer

e no

sign

ifica

nt d

iffer

ence

s in

the

rela

tions

hip

betw

een

insu

ranc

e st

atus

and

alc

ohol

and

toba

cco

use

in th

e fir

st tw

o tri

mes

ters

. How

ever

, in

the

third

tri

mes

ter,

3.18

% o

f ins

ured

pre

gnan

t wom

en u

sed

alco

hol i

n th

e pa

st m

onth

ver

sus 0

.15%

of

unin

sure

d pr

egna

nt w

omen

. The

rela

tions

hip

betw

een

insu

ranc

e st

atus

and

toba

cco

use

was

no

t sig

nific

ant i

n th

e th

ird tr

imes

ter.

Des

pite

hea

lth in

sura

nce

cove

rage

, tob

acco

use

per

sist

ed

durin

g pr

egna

ncy.

Buc

hana

n (2

017)

In-p

atie

nt re

cord

s and

follo

w u

p ph

one

surv

eys

Smok

ing

abst

inen

ce

This

real

-wor

ld, h

ospi

tal-b

ased

, opt

-out

toba

cco

asse

ssm

ent a

nd c

essa

tion

prog

ram

was

abl

e to

reac

h 19

8 pe

rinat

al sm

oker

s dur

ing

thei

r inp

atie

nt st

ay a

nd a

noth

er 8

3 pa

tient

s not

seen

at

the

beds

ide

by p

hone

afte

r dis

char

ge, y

ield

ing

an o

vera

ll re

ach

rate

of 6

7% (2

81/4

21).

Thos

e co

unse

led

in th

e ho

spita

l wer

e tw

ice

as li

kely

to b

e ab

stin

ent f

rom

smok

ing

at a

ny ti

me

durin

g th

e 30

day

s pos

t-dis

char

ge. T

his o

pt-o

ut se

rvic

e re

ache

d a

high

ly n

icot

ine-

depe

nden

t pe

rinat

al p

opul

atio

n, m

any

of w

hom

wer

e re

cept

ive

to th

e se

rvic

e, a

nd it

app

eare

d to

impr

ove

abst

inen

ce ra

tes p

ost-d

isch

arge

.

Cam

pbel

l (20

17)

UK

Nat

iona

l Hea

lth S

ervi

ce

data

base

Num

ber o

f ref

erra

ls, q

uit d

ate

set,

smok

ing

abst

inen

ce ra

tes

In a

hos

pita

l with

an

‘opt

-in’ r

efer

ral s

yste

m, a

ddin

g C

O sc

reen

ing

with

‘opt

-out

’ ref

erra

ls a

s w

omen

atte

nded

ultr

asou

nd e

xam

inat

ions

dou

bled

the

num

bers

of p

regn

ant s

mok

ers s

ettin

g qu

it da

tes a

nd re

porti

ng sm

okin

g ce

ssat

ion.

App

roxi

mat

ely

2300

wom

en a

ttend

ed a

nten

atal

ca

re in

eac

h pe

riod.

Bef

ore

the

impl

emen

tatio

n, 5

36 (2

3.4%

) wom

en re

porte

d sm

okin

g at

‘b

ooki

ng’ a

nd 2

90 (1

2.7%

) wer

e re

ferr

ed to

SSS

. Afte

r the

impl

emen

tatio

n, 5

24 (2

2.9%

) w

omen

repo

rted

smok

ing

at ‘b

ooki

ng’,

an a

dditi

onal

156

smok

ers (

6.8%

) wer

e id

entifi

ed v

ia

the

‘opt

-out

’ ref

erra

ls a

nd, i

n to

tal,

421

(18.

4%) w

ere

refe

rred

to S

SS. O

ver t

wic

e as

man

y w

omen

set a

qui

t dat

e w

ith th

e SS

S af

ter ‘

opt-o

ut’ r

efer

rals

wer

e im

plem

ente

d (1

21 (5

.3%

, 95

% C

I 4.4

% to

6.3

%) c

ompa

red

to 5

7 (2

.5%

, 95%

CI 1

.9%

to 3

.2%

) bef

ore

impl

emen

tatio

n)

and

repo

rted

bein

g ab

stin

ent 4

wee

ks la

ter (

93 (4

.1%

, 95%

CI 3

.3%

to 4

.9%

) com

pare

d to

46

(2.0

%, 1

.5%

to 2

.7%

) bef

ore

impl

emen

tatio

n).

FIGURES AND TABLES


87

TABLE

5: C

ontin

ued

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Che

rtok

(201

5)Su

rvey

s (se

lf-re

port

ques

tionn

aire

s)Sm

okin

g ce

ssat

ion

or

redu

ctio

nO

ver t

he c

ours

e of

the

inte

rven

tion,

ther

e w

as a

sign

ifica

nt re

duct

ion

in c

igar

ette

smok

ing

durin

g pr

egna

ncy.

Als

o, w

omen

exp

ress

ed a

hig

her l

evel

of c

onfid

ence

in fe

elin

g ab

le to

re

duce

smok

ing

durin

g pr

egna

ncy

com

pare

d to

qui

tting

smok

ing.

The

repo

rted

aver

age

num

ber o

f cig

aret

tes s

mok

ed in

a d

ay sh

owed

a si

gnifi

cant

effe

ct in

redu

ctio

n ov

er ti

me,

from

9.

9 (4

.9) a

t bas

elin

e to

8.1

(4.9

) at t

ime

1, to

7.0

(4.7

) by

time

2, a

nd 6

.0 (5

.6) b

y th

e en

d of

pr

egna

ncy,

for a

n ov

eral

l red

uctio

n of

43.

5% o

ver t

ime.

Col

eman

-Cow

ger

(201

8)U

rine

test

ing,

Sur

veys

Sm

okin

g ce

ssat

ion

rate

sLi

mite

d be

nefit

s of i

nclu

ding

pho

ne-b

ased

con

tinui

ng c

are

to st

anda

rd c

are

for s

mok

ing

cess

atio

n du

ring

preg

nanc

y w

ere

foun

d. T

here

wer

e no

sign

ifica

nt d

iffer

ence

s in

aver

age

cotin

ine

leve

ls b

etw

een

the

Expe

rimen

tal a

nd C

ontro

l gro

up a

t any

of t

he ti

me

poin

ts. T

here

w

ere

no st

atis

tical

ly si

gnifi

cant

diff

eren

ces i

n th

e nu

mbe

r of t

obac

co p

rodu

cts u

sed

per d

ay

betw

een

the

Expe

rimen

tal a

nd C

ontro

l gro

ups.

Mor

e pa

rtici

pant

s in

the

Expe

rimen

tal g

roup

w

ere

abst

inen

t at 6

wee

ks p

ostp

artu

m (3

9% v

s 25%

; p=0

.18)

and

3 m

onth

s pos

tpar

tum

(2

5% v

s 14%

; p=0

.21)

, but

the

perc

enta

ge o

f sm

okin

g ab

stin

ent w

omen

was

sim

ilar f

or th

e Ex

perim

enta

l and

Con

trol g

roup

s at 6

mon

ths p

ostp

artu

m.

Cum

min

s (20

16)

Self-

repo

rt te

leph

one

inte

rvie

ws,

saliv

a sa

mpl

esQ

uit a

ttem

pts,

smok

ing

abst

inen

ce ra

tes,

rela

pse

rate

sTh

e st

udy

dem

onst

rate

d th

at a

tele

phon

e-ba

sed,

pre

gnan

cy-s

peci

fic p

roto

col w

ithou

t fin

anci

al in

cent

ives

can

incr

ease

smok

ing

cess

atio

n du

ring

preg

nanc

y, w

ith a

sust

aine

d ef

fect

po

stpa

rtum

. At t

he e

nd o

f pre

gnan

cy, w

omen

in th

e in

terv

entio

n w

ere

1.5

times

mor

e lik

ely

to

be a

bstin

ent t

han

thos

e in

the

cont

rol g

roup

. A

bstin

ence

was

hig

her f

or th

e in

terv

entio

n th

an

the

cont

rol g

roup

at t

he e

nd o

f pre

gnan

cy (3

0-da

y ab

stin

ence

, 29.

6% v

s 20.

1%; p

<0.0

01),

2 m

onth

s pos

tpar

tum

(90-

day

abst

inen

ce, 2

2.1%

vs 1

4.8%

; p<0

.001

), an

d 6

mon

ths p

ostp

artu

m

(180

-day

abs

tinen

ce, 1

4.4%

vs 8

.2%

; p<0

.001

). C

otin

ine-

corr

ecte

d 7-

day

abst

inen

ce ra

tes a

t th

e en

d of

pre

gnan

cy su

ppor

ted

the

inte

rven

tion

effe

ct (3

5.8%

vs.

22.5

%)

Eddy

(201

5)St

anda

rd p

oint

of c

are

data

form

Num

ber o

f sm

okin

g in

terv

entio

ns b

y m

idw

ives

; sm

okin

g ce

ssat

ion

rate

s of

wom

en a

nd h

ouse

hold

m

embe

rs

Ove

r the

cou

rse

of th

e pr

ojec

t, th

e si

x m

idw

ives

del

iver

ed a

tota

l of 1

086

AB

C in

terv

entio

ns

to th

e 10

1 w

omen

. Thi

s tot

al is

com

pris

ed o

f 438

repo

rted

inci

denc

es o

f ask

ing

abou

t sm

okin

g be

havi

or, 3

58 in

cide

nces

of o

fferin

g br

ief a

dvic

e an

d, 2

90 in

cide

nces

of o

fferin

g re

ferr

al

to sp

ecia

list c

essa

tion

supp

ort t

o w

omen

. Six

teen

wom

en a

ccep

ted

refe

rral

to th

e de

dica

ted

preg

nanc

y sm

okin

g ce

ssat

ion

serv

ice—

all o

f who

m h

ad a

t lea

st o

ne re

porte

d co

ntac

t with

the

prov

ider

. Par

tner

s and

oth

er a

dults

in th

e ho

useh

old

rece

ived

few

er A

BC

inte

rven

tions

than

di

d th

e w

omen

, as t

hey

wer

e no

t pre

sent

eve

ry ti

me

the

mid

wife

vis

ited.

Thi

rty-tw

o w

omen

be

cam

e sm

oke-

free

dur

ing

the

cour

se o

f the

pro

ject

follo

win

g th

e m

idw

ives

’ int

erve

ntio

n.

Sixt

een

(50%

) of t

he 3

2 w

omen

who

bec

ame

smok

e-fr

ee re

com

men

ced

smok

ing,

nin

e du

ring

preg

nanc

y, a

nd se

ven

post

nata

lly. T

en p

artn

ers (

15%

) bec

ame

smok

e-fr

ee fo

llow

ing

the

LMC

m

idw

ives

’ int

erve

ntio

n; in

five

of t

hese

cas

es th

e w

oman

als

o be

cam

e sm

oke-

free

. Thr

ee

othe

r adu

lts (2

.7%

) als

o be

cam

e sm

oke-

free

and

in tw

o of

thes

e ca

ses t

he w

oman

her

self

also

be

cam

e sm

oke-

free

.

FIGURES AND TABLES


88

TABLE

5: C

ontin

ued

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Engl

and

(201

7)St

ate

stan

dard

cer

tifica

te o

f liv

e bi

rth q

uest

ionn

aire

Smok

ing

cess

atio

n ra

tes

Expo

sure

to a

nat

iona

l ant

i-sm

okin

g ca

mpa

ign

for a

gen

eral

aud

ienc

e w

as a

ssoc

iate

d w

ith

smok

ing

cess

atio

n in

pre

gnan

t wom

en. C

essa

tion

rate

s wer

e st

able

dur

ing

2009

–201

1 bu

t in

crea

sed

at th

e tim

e Ti

ps 2

012

aire

d an

d re

mai

ned

elev

ated

. Ove

rall,

32.

9% o

f une

xpos

ed

and

34.7

% o

f exp

osed

smok

ers q

uit b

y th

e th

ird tr

imes

ter (

p<0.

001)

. Exp

osur

e to

Tip

s 201

2 w

as a

ssoc

iate

d w

ith in

crea

sed

cess

atio

n (a

djus

ted

OR

: 1.0

7, 9

5% C

I 1.0

5 to

1.1

0). C

essa

tion

bene

fits w

ere

obse

rved

acr

oss m

ost s

ubgr

oups

, inc

ludi

ng a

dole

scen

ts u

nder

18

year

s of a

ge,

Med

icai

d-in

sure

d w

omen

, and

wom

en w

ith le

ss th

an a

hig

h sc

hool

edu

catio

n. M

edia

buy

dos

e w

as p

ositi

vely

ass

ocia

ted

with

ces

satio

n ra

tes.

Falli

n-B

enne

t (20

19)

Expi

red

air c

arbo

n m

onox

ide

(EA

CO

), se

lf-re

port,

stan

dard

ized

sc

ales

Smok

ing

cess

atio

n ra

tes;

de

pres

sion

, stre

ss, a

nd

nico

tine

depe

nden

ce sc

ale

ratin

gs; c

igar

ette

s per

day

The

pilo

t PW

N in

terv

entio

n en

rolle

d a

high

-ris

k po

pula

tion

of p

regn

ant o

r ear

ly p

ostp

artu

m

patie

nts w

ho sm

oked

and

dem

onst

rate

d si

gnifi

cant

redu

ctio

ns in

cig

aret

tes s

mok

ed p

er d

ay b

y pa

rtici

pant

s, as

wel

l as d

ecre

ases

in p

ostn

atal

dep

ress

ion

and

stre

ss. T

his p

ilot p

rogr

am h

ad

min

imal

succ

ess w

ith p

rom

otin

g to

tal t

obac

co c

essa

tion.

How

ever

, thi

s pro

gram

dem

onst

rate

d su

cces

s in

redu

cing

cig

aret

tes p

er d

ay a

nd n

icot

ine

depe

nden

ce.

Forin

ash

(201

8)Se

lf-re

port,

exh

aled

car

bon

mon

oxid

e le

vels

(eC

O)

Bio

chem

ical

ly v

erifi

ed

smok

ing

cess

atio

n, se

lf-re

porte

d qu

it ra

tes,

birth

ou

tcom

es

Two-

wee

k ce

ssat

ion

was

ach

ieve

d by

57.

1 pe

rcen

t of t

he te

xtin

g gr

oup

vers

us 3

1.3

perc

ent

in th

e co

ntro

l gro

up. N

o di

ffere

nce

was

foun

d in

ces

satio

n ra

tes f

or c

old

turk

ey (5

0%),

NRT

pa

tch

(38.

9%) o

r bup

rion

cess

atio

n (5

0%).

At f

ollo

w-u

p, 8

wom

en re

porte

d th

ey su

cces

sful

ly

quit,

whi

le 7

of t

hose

wer

e ve

rified

by

CO

test

ing.

Pos

t ana

lysi

s rev

eale

d th

at th

ere

wer

e no

st

atis

tical

diff

eren

ces b

etw

een

blac

k an

d w

hite

pat

ient

s and

thos

e w

ho li

ved

with

or w

ithou

t sm

oker

s in

the

hous

ehol

d. H

owev

er, b

lack

pat

ient

s in

the

text

ing

grou

p w

ere

mor

e lik

ely

to

quit

than

bla

ck p

atie

nts i

n th

e SO

C-o

nly

grou

p. T

here

wer

e no

diff

eren

ces i

n bi

rth o

utco

mes

be

twee

n gr

oups

.

Glo

ver (

2016

)In

per

son

ques

tionn

aire

s, in

terv

iew

s, an

d ho

spita

l birt

h re

cord

sN

umbe

r of p

regn

ant s

mok

ers

reac

hed,

qui

t rat

esTh

e cu

ltura

l com

mun

ity h

ealth

wor

kers

(CW

Hs)

wer

e ab

le to

find

wom

en w

ho sm

oked

whi

le

preg

nant

. Alth

ough

they

did

pro

vide

supp

ort a

t the

initi

al v

isit,

the

cont

inue

d le

vel o

f sup

port

prov

ided

var

ied.

Bas

ed o

n th

e m

edic

al re

cord

s, 24

% re

porte

d qu

ittin

g. M

āori

CH

Ws a

re b

est

plac

ed to

find

wom

en e

arly

in p

regn

ancy

and

pro

vide

ces

satio

n in

form

atio

n, su

ppor

t and

re

ferr

al in

a w

ay c

onsi

sten

t with

trad

ition

al M

āori

know

ledg

e an

d pr

actic

es, a

nd th

is st

udy

sugg

ests

such

an

inte

rven

tion

coul

d in

crea

se a

bstin

ence

from

smok

ing

whi

le p

regn

ant.

Grif

fis (2

016)

Enro

llmen

t dat

a, in

-per

son

or

tele

phon

e in

terv

iew

s, bi

rth

certi

ficat

e da

ta

Cha

nge

in n

umbe

r of

ciga

rette

s sm

oked

, sm

okin

g ce

ssat

ion

rate

s, ho

w sm

okin

g be

havi

ors w

ere

addr

esse

d,

how

the

appr

oach

ed

influ

ence

d sm

okin

g be

havi

ors

A p

rogr

am e

ffect

was

seen

for s

mok

ing

cess

atio

n am

ong

light

(les

s tha

n te

n ci

gare

ttes d

urin

g th

e fir

st tr

imes

ter)

and

hea

vy (2

0 or

mor

e ci

gare

ttes d

urin

g th

e fir

st tr

imes

ter)

bas

elin

e sm

okin

g cl

ient

s. C

lient

s who

wer

e lig

ht b

asel

ine

smok

ers h

ad a

45%

pro

babi

lity

of sm

okin

g ce

ssat

ion

com

pare

d to

38%

for c

ompa

rison

wom

en (p

<0.

01; T

able

3).

Hea

vier

bas

elin

e sm

okin

g cl

ient

s als

o ha

d a

high

er p

roba

bilit

y of

smok

ing

cess

atio

n—16

% c

ompa

red

to 1

2%

(p =

0.01

). Q

ualit

ativ

e: F

our o

f the

19

clie

nts w

ho sm

oked

des

crib

ed a

chie

ving

ces

satio

n, w

ith

thre

e su

gges

ting

that

thei

r beh

avio

r cha

nge

was

mot

ivat

ed p

rimar

ily b

y th

eir p

regn

ancy

rath

er

than

a d

irect

pro

gram

effe

ct.

Ther

e w

as a

lso

a pr

ogra

m e

ffect

for s

mok

ing

redu

ctio

n. U

sing

sm

okin

g to

redu

ce st

ress

was

a fr

eque

ntly

repo

rted

barr

ier t

o sm

okin

g re

duct

ion

and

cess

atio

n.

FIGURES AND TABLES


89

TABLE

5: C

ontin

ued

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Han

kins

(201

6)R

estri

cted

-use

199

1–20

09 N

atal

ity

Det

ail F

iles,

a C

lean

Air

Dat

es

Tabl

e R

epor

t, an

d th

e Ta

x B

urde

n of

Tob

acco

- sel

f-re

port

num

ber o

f ci

gare

ttes s

mok

ed p

er d

ay

Num

ber o

f cig

aret

tes

smok

ed, s

mok

ing

cess

atio

n,

neon

atal

hea

lth o

utco

mes

Smok

ing

bans

had

no

effe

ct o

n m

ater

nal s

mok

ing

beha

vior

. We

find

limite

d ev

iden

ce

that

thes

e sm

okin

g ba

ns h

ave

a m

ater

ial i

mpa

ct o

n ne

onat

al h

ealth

. The

y se

em to

nei

ther

in

duce

pre

gnan

t wom

en to

stop

smok

ing

nor r

educ

e th

e nu

mbe

r of c

igar

ette

s con

sum

ed in

a

mea

ning

ful w

ay. T

here

fore

, it i

s not

surp

risin

g th

at w

e fin

d no

effe

ct o

n he

alth

out

com

es

of n

eona

tes b

orn

to m

othe

rs w

ho re

port

smok

ing.

Fro

m a

pub

lic h

ealth

per

spec

tive,

it is

di

sapp

oint

ing

that

we

also

find

no

effe

ct o

n th

e ne

wbo

rns o

f non

smok

ers.

Har

ris (2

015)

Que

stio

nnai

res,

stan

dard

ized

scal

es,

urin

ary

cotin

ine

leve

lsSm

okin

g ab

stin

ence

and

re

duct

ion

rate

sFo

r the

web

-bas

ed c

ontin

genc

y m

anag

emen

t (C

M),

two

of se

ven

(28.

57%

) of t

he p

artic

ipan

ts

achi

eved

abs

tinen

ce, a

nd th

ree

of 1

0 (3

0%) o

f tho

se e

nrol

led

in p

hone

cou

nsel

ing

wer

e ab

stin

ent b

y la

te p

regn

ancy

. Par

ticip

ants

in C

M a

ttain

ed a

bstin

ence

mor

e ra

pidl

y th

an th

ose

in p

hone

cou

nsel

ing.

How

ever

, tho

se in

the

phon

e co

unse

ling

expe

rienc

ed le

ss re

laps

e to

sm

okin

g, a

nd a

gre

ater

per

cent

age

of th

ese

parti

cipa

nts r

educ

ed th

eir s

mok

ing

by a

t lea

st 5

0%.

Hav

ard

(201

8)H

ealth

reco

rds f

or a

ll pr

egna

ncie

s re

sulti

ng in

birt

h in

New

Sou

th

Wal

es

Mon

thly

smok

ing

prev

alen

cePr

eval

ence

of s

mok

ing

durin

g pr

egna

ncy

decr

ease

d fr

om 2

003

to 2

011

over

all (

0.39

% p

er

mon

th),

and

for a

ll st

rata

exa

min

ed. F

or p

regn

anci

es o

vera

ll, n

one

of th

e ev

alua

ted

initi

ativ

es

was

ass

ocia

ted

with

a c

hang

e in

the

trend

of s

mok

ing

durin

g pr

egna

ncy.

Sig

nific

ant c

hang

es

asso

ciat

ed w

ith in

crea

sed

toba

cco

tax

and

the

exte

nsio

n of

the

smok

ing

ban

(in c

ombi

natio

n w

ith g

raph

ic w

arni

ngs)

wer

e fo

und

in so

me

stra

ta. T

he d

eclin

ing

prev

alen

ce o

f sm

okin

g du

ring

preg

nanc

y be

twee

n 20

03 to

201

1, w

hile

enc

oura

ging

, doe

s not

app

ear t

o be

dire

ctly

re

late

d to

gen

eral

pop

ulat

ion

antis

mok

ing

activ

ities

or a

pre

gnan

cy-s

peci

fic c

ampa

ign

unde

rtake

n in

this

per

iod.

It re

mai

ns p

ossi

ble,

how

ever

, tha

t the

se a

ntis

mok

ing

activ

ities

hav

e in

dire

ctly

impa

cted

the

prev

alen

ce o

f mat

erna

l sm

okin

g, p

erha

ps th

roug

h gr

adua

l cha

nges

in

publ

ic se

ntim

ent.

Jin

(201

8)Se

lf-re

port,

Urin

e co

tinin

e D

aily

cig

aret

te c

onsu

mpt

ion,

qu

it at

tem

pts,

smok

ing

cess

atio

n

Afte

r 12

wee

ks tr

eatm

ent,

ther

e w

ere

no si

gnifi

cant

diff

eren

ces i

n nu

mbe

r of s

mok

ers w

ho

quit

smok

ing

(by

self-

repo

rt an

d ur

ine

cotin

ine

verifi

ed),

nor t

he d

aily

cig

aret

tes c

onsu

mpt

ion,

no

r qui

t atte

mpt

s bet

wee

n th

e in

terv

entio

n an

d co

ntro

l gro

ups.

No

sign

ifica

nt d

iffer

ence

w

as fo

und

at d

eliv

ery

for q

uitti

ng b

y se

lf-re

port

or u

rine

cotin

ine

verifi

ed, d

aily

cig

aret

te

cons

umpt

ion,

or q

uit a

ttem

pts b

etw

een

the

two

grou

ps.

Lee

(201

5)St

anda

rd sc

ales

, sel

f-re

port,

urin

e co

tinin

e Le

vel o

f mot

ivat

ion

to q

uit

smok

ing,

smok

ing

abst

inen

ce

rate

s

Com

para

ble

cess

atio

n ra

tes b

etw

een

the

cogn

itive

beh

avio

ral i

nter

vent

ion

(CB

C) a

nd

cont

rol b

est p

ract

ice

(BP)

gro

ups i

n th

e in

tent

-to-tr

eat a

naly

sis.

How

ever

, am

ong

thos

e w

ho

parti

cipa

ted

in th

e 5-

mon

th p

ostp

artu

m fo

llow

-up

asse

ssm

ent,

wom

en w

ho w

ere

in th

e C

BC

gr

oup

wer

e m

ore

likel

y to

be

abst

inen

t, co

mpa

red

to th

ose

in th

e B

P gr

oup.

Lope

z (2

015a

)D

epre

ssio

n sc

ale

scor

es, b

reat

h C

O,

urin

e co

tinin

eD

epre

ssio

n sc

ores

, sm

okin

g ab

stin

ence

The

ince

ntiv

es-b

ased

inte

rven

tion

incr

ease

d ab

stin

ence

rate

s sev

eral

-fol

d ab

ove

cont

rol

leve

ls a

mon

g de

pres

sion

-pro

ne a

nd d

epre

ssio

n-ne

gativ

e w

omen

alik

e th

roug

h 24

-wee

ks

post

partu

m, 1

2-w

eeks

afte

r the

inte

rven

tion

was

dis

cont

inue

d. P

rovi

ding

this

ince

ntiv

e-ba

sed

smok

ing-

cess

atio

n in

terv

entio

n to

pre

gnan

t and

new

ly p

ostp

artu

m w

omen

who

are

at r

isk

for p

ostp

artu

m d

epre

ssio

n de

crea

ses d

epre

ssiv

e sy

mpt

oms.

The

mag

nitu

de o

f cha

nge

was

su

ffici

ent t

o re

duce

by

2–5

fold

the

prop

ortio

n of

wom

en w

ith d

epre

ssio

n sc

ale

tota

l sco

res i

n th

e cl

inic

al ra

nge

durin

g th

e in

itial

3-m

onth

s pos

tpar

tum

usi

ng c

ut-p

oint

s ind

icat

ive

of m

ild o

r gr

eate

r (≥1

7) a

nd m

oder

ate

or g

reat

er (≥

21) d

epre

ssio

n. T

here

wer

e no

t suf

ficie

nt n

umbe

rs o

f w

omen

scor

ing

in th

e se

vere

rang

e (≥

30) t

o co

nduc

t mea

ning

ful c

ompa

rison

s at t

hat s

ever

ity

leve

l.

FIGURES AND TABLES


90

TABLE

5: C

ontin

ued

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Lope

z (2

015b

)Q

uest

ionn

aire

s, br

eath

CO

& u

rine

cotin

ine,

del

ay d

isco

untin

g ta

sk

scor

es (D

D),

Bar

ratt

Impu

lsiv

enes

s Sc

ale

(BIS

)

Diff

eren

ces i

n im

puls

iven

ess,

smok

ing

cess

atio

n Th

ere

wer

e no

indi

vidu

al d

iffer

ence

s in

impu

lsiv

enes

s as m

easu

red

by e

ither

DD

or B

IS w

as

a si

gnifi

cant

mod

erat

or o

f sm

okin

g ce

ssat

ion

outc

omes

in th

e si

ngle

pro

spec

tive

trial

or w

hen

DD

was

exa

min

ed a

cros

s mul

tiple

tria

ls. T

hat i

s, th

ere

was

no

evid

ence

of a

sign

ifica

nt m

ain

effe

ct o

f eith

er im

puls

iven

ess m

easu

re o

r int

erac

tions

of t

hem

with

trea

tmen

t con

ditio

n in

pr

edic

ting

ante

partu

m o

r pos

tpar

tum

smok

ing

stat

us. T

urni

ng to

wha

t did

pre

dict

abs

tinen

ce

from

smok

ing

in th

e pr

esen

t stu

dy, t

he re

sults

are

stro

nges

t for

pre

dict

ing

late

-pre

gnan

cy

abst

inen

ce. T

hree

var

iabl

es p

redi

cted

acr

oss t

he si

ngle

and

mul

tiple

tria

ls: b

eing

ass

igne

d to

th

e in

cent

ive-

base

d in

terv

entio

n, h

avin

g lo

wer

bas

elin

e sm

okin

g ra

tes,

and

havi

ng tr

ied

to q

uit

smok

ing

prio

r to

the

curr

ent p

regn

ancy

, with

the

mod

el fi

t of t

hese

pre

dict

ors b

eing

reas

onab

ly

stro

ng. H

avin

g le

ss th

an 1

2 ye

ars o

f edu

catio

n w

as a

pre

dict

or in

ana

lyse

s bas

ed o

n m

ultip

le

trial

s, bu

t not

the

sing

le tr

ial.

Min

ian

(201

6)Su

rvey

, pho

ne in

terv

iew

The

degr

ee to

whi

ch

blog

ging

was

per

ceiv

ed to

su

ppor

t sm

okin

g ce

ssat

ion

Parti

cipa

nts p

erce

ived

the

blog

ging

pro

cess

to h

elp

them

redu

ce o

r qui

t sm

okin

g; th

eir

perc

eptio

ns w

ere

supp

orte

d by

thei

r rep

orte

d sm

okin

g st

atus

, whi

ch a

ppea

red

to d

ecre

ase

over

th

e co

urse

of t

heir

expe

rienc

e bl

oggi

ng fo

r PR

EGN

ETS,

an

onlin

e fo

rum

. One

exp

lana

tion

for t

hese

find

ings

is th

at p

artic

ipan

ts e

xper

ienc

ed so

me

of th

e so

cial

and

per

sona

l ben

efits

of

blog

ging

that

are

foun

d to

influ

ence

smok

ing

cess

atio

n.

Mor

gan

(201

6)In

door

air

qual

ity m

easu

rem

ents

(I

AQ

), in

terv

iew

sFe

asib

ility

of I

AQ

, cha

nge

in

smok

ing

beha

vior

sTh

e in

terv

entio

n w

as fe

asib

le (r

ecru

itmen

t rat

e w

as a

ppro

xim

atel

y 30

%) a

s a ‘l

ight

touc

h’

add-

on to

rout

ine

care

del

iver

ed b

y in

depe

nden

t res

earc

h m

idw

ives

(Abe

rdee

n) a

s wel

l as

whe

n em

bedd

ed in

an

exis

ting

smok

ing

cess

atio

n se

rvic

e (C

oven

try).

Inte

rvie

ws i

ndic

ated

th

e w

omen

val

ued

pers

onal

ized

info

rmat

ion

and

the

addi

tiona

l lite

racy

in sm

okin

g (a

nd

its a

ssoc

iate

d da

nger

s) th

ey g

aine

d, e

spec

ially

whe

n th

ey st

rugg

led

with

qui

tting

. D

iver

se

acco

unts

of s

mok

ing

beha

vior

s and

exp

erie

nces

of p

artic

ipat

ion

wer

e gi

ven.

Man

y w

omen

re

porte

d ch

ange

s to

thei

r sm

okin

g be

havi

ors,

incl

udin

g ha

ving

smok

ing

rest

rictio

ns in

pla

ce

at h

ome.

Mos

t wom

en w

ante

d to

mak

e fu

rther

cha

nges

to th

eir o

wn

beha

vior

, but

cou

ld n

ot

com

mit

or fe

lt co

nstra

ined

by

livin

g w

ith a

par

tner

or f

amily

mem

bers

who

smok

ed. S

ome

expr

esse

d de

sire

to c

hang

e th

ese

peop

le’s

smok

ing

beha

vior

s. O

ther

s cou

ld n

ot e

nvis

ion

quitt

ing.

Onl

y on

e w

oman

in A

berd

een

enga

ged

with

serv

ices

follo

win

g th

e in

terv

entio

n an

d al

l six

wom

en in

Cov

entry

wer

e al

read

y pa

rtici

patin

g in

a c

essa

tion

prog

ram

. IA

Q w

as

supp

ortiv

e of

initi

atin

g sm

okin

g ce

ssat

ion.

Nau

ghto

n (2

017)

Surv

eys,

data

from

mob

ile te

xt

syst

em, e

xhal

ed b

reat

h C

O, s

aliv

a co

tinin

e

Valid

ated

con

tinuo

us

smok

ing

abst

inen

ce, s

elf-

repo

rted

smok

ing

beha

vior

, pa

rtici

patio

n in

follo

w-u

p,

cost

per

qui

tter

Usi

ng th

e va

lidat

ed, c

ontin

uous

abs

tinen

ce o

utco

me,

5.4

% (1

1 of

203

) of M

iQui

t par

ticip

ants

w

ere

abst

inen

t ver

sus 2

.0%

(fou

r of 2

04) o

f usu

al c

are

parti

cipa

nts.

The

Bay

es fa

ctor

for

this

out

com

e w

as 2

.23.

Com

plet

enes

s of f

ollo

w-u

p at

36

wee

ks g

esta

tion

was

sim

ilar i

n bo

th

grou

ps; p

rovi

sion

of s

elf-

repo

rt sm

okin

g da

ta w

as 6

4% (M

iQui

t) an

d 65

% (u

sual

car

e) a

nd

abst

inen

ce v

alid

atio

n ra

tes w

ere

56%

(MiQ

uit)

and

61%

(usu

al c

are)

. The

incr

emen

tal c

ost-

per-q

uitte

r was

£13

3.53

(95%

CI =

–£3

95.7

8 to

843

.62)

.

FIGURES AND TABLES


91

TABLE

5: C

ontin

ued

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Ola

iya

(201

5)Se

lf-re

port,

med

ical

reco

rds

Qui

t rat

es, o

dds o

f qui

tting

, bi

rth w

eigh

t O

f 71,

526

preg

nant

smok

ers a

t WIC

enr

ollm

ent,

23%

qui

t. O

dds o

f qui

tting

wer

e hi

gher

am

ong

wom

en w

ho a

ttend

ed a

clin

ic a

fter v

ersu

s bef

ore

clin

ic st

aff w

as tr

aine

d (a

djus

ted

odds

ra

tio, 1

.16;

95%

con

fiden

ce in

terv

al, 1

.04–

1.29

). Th

e ad

just

ed m

ean

infa

nt b

irth

wei

ght w

as,

on a

vera

ge, 9

6 g

high

er a

mon

g w

omen

who

repo

rted

quitt

ing

(P <

0.0

001)

, reg

ardl

ess o

f clin

ic

train

ing

stat

us. I

n ru

ral,

non-

App

alac

hian

cou

ntie

s and

App

alac

hian

cou

ntie

s, th

e od

ds o

f qu

ittin

g sm

okin

g w

ere

high

er a

mon

g w

omen

atte

ndin

g a

clin

ic a

fter i

t was

trai

ned,

com

pare

d w

ith w

omen

who

vis

ited

the

sam

e cl

inic

prio

r to

train

ing

aOR

(1.3

1; 9

5% C

I, 1.

07–1

.60)

and

aO

R (1

.25;

95%

CI,

1.01

–1.5

4), r

espe

ctiv

ely.

The

re w

as n

o di

ffere

nce

in th

e od

ds o

f qui

tting

sm

okin

g by

clin

ic tr

aini

ng st

atus

am

ong

wom

en a

ttend

ing

clin

ics i

n m

etro

polit

an (a

OR

, 1.0

0;

95%

CI,

0.83

–1.2

0) o

r sub

urba

n (a

OR

, 0.9

6; 9

5% C

I, 07

3–1.

27) c

ount

ies.

Ols

on (2

019)

Surv

eys,

urin

e co

tinin

e Q

uit r

ates

with

out r

elap

se

durin

g pr

egna

ncy,

smok

ing

cess

atio

n th

at la

sted

to

post

partu

m v

isit

The

quit

rate

s bet

wee

n th

e gr

oups

did

not

diff

eren

t sig

nific

antly

(Int

erve

ntio

n 36

.4%

, Con

trol

29.4

%).

How

ever

, sig

nific

antly

mor

e m

othe

rs w

ho h

ad re

ceiv

ed th

e in

terv

entio

n qu

it an

d co

ntin

ued

as n

onsm

oker

s pos

tpar

tum

(Int

erve

ntio

n 31

.8%

, Con

trol 1

6.2%

)

Pass

ey (2

018)

Self-

repo

rted

smok

ing

leve

ls, b

reat

h C

OPe

rcep

tion

of p

rogr

am,

prog

ram

com

plet

ion

rate

s, br

eath

CO

mea

sure

s

The

prog

ram

was

wel

l rec

eive

d, w

ith a

reas

onab

le e

nrol

men

t rat

e (5

8%) a

nd e

xcel

lent

co

mpl

etio

n ra

te (8

6%).

The

high

com

plet

ion

rate

and

the

expr

esse

d vi

ews o

f the

wom

en

inte

rvie

wed

indi

cate

that

wom

en a

ppre

ciat

ed th

e in

tens

ive

supp

ort t

hey

rece

ived

. Th

e in

tens

ity o

f the

pro

gram

pro

vide

d ch

alle

nges

for i

mpl

emen

tatio

n. In

par

ticul

ar, t

he g

roup

s w

ere

diffi

cult

and

reso

urce

inte

nsiv

e to

run.

Oth

er st

udie

s with

pre

gnan

t sm

oker

s hav

e fo

und

diffi

culti

es w

ith g

roup

s, be

caus

e so

me

wom

en la

ck c

onfid

ence

to a

ttend

, and

tran

spor

t di

fficu

lties

and

con

flict

ing

com

mitm

ents

can

pre

vent

atte

ndan

ce. T

wic

e-w

eekl

y vi

sits

ear

ly in

th

e pr

ogra

m w

ere

also

diffi

cult

to m

anag

e, p

artic

ular

ly if

the A

MIH

S te

am w

as u

nder

staf

fed.

58

% o

f the

19

who

com

plet

ed th

e pr

ogra

m h

ad C

O c

onfir

med

qui

t at a

ny ti

me

durin

g th

e in

terv

entio

n, a

nd 4

2% C

O c

onfir

med

qui

t lat

e in

pre

gnan

cy. 8

4% a

ttem

pted

to q

uit a

nd 7

9%

quit

for a

t lea

st 2

4 ho

urs (

self-

repo

rted)

.

Patte

n (2

019)

Urin

e co

tinin

e le

vels

, pho

ne

inte

rvie

ws

Perc

eptio

ns o

f pro

gram

, qui

t ra

tes,

bioc

hem

ical

ly v

erifi

ed

smok

ing

abst

inen

ce

The

biom

arke

r fee

dbac

k in

terv

entio

n de

mon

stra

ted

feas

ibili

ty a

nd a

ccep

tabi

lity

amon

g pr

egna

nt A

lask

an n

ativ

e w

omen

, but

it w

as n

o m

ore

effe

ctiv

e th

an u

sual

car

e w

ith re

spec

t to

smok

ing

abst

inen

ce a

t wee

k 5

or a

t del

iver

y. B

oth

stud

y gr

oups

ach

ieve

d id

entic

al

bioc

hem

ical

ly v

erifi

ed sm

okin

g ab

stin

ence

rate

s of 2

0% (2

6% p

er-p

roto

col)

at d

eliv

ery.

Rey

nold

s (20

19)

Bre

ath

CO

, web

site

stat

istic

s, su

rvey

, med

ical

reco

rds

Parti

cipa

tion/

follo

w-u

p ra

te,

web

site

vis

its, q

uit r

ates

, pe

rcep

tion

of p

rogr

am

The

leve

l of i

nter

est a

nd p

artic

ipat

ion

rate

in th

e st

udy

as w

ell a

s the

leve

l of e

ngag

emen

t with

th

e in

terv

entio

n w

as lo

wer

than

exp

ecte

d. O

f the

13

wom

en ra

ndom

ized

to th

e in

terv

entio

n gr

oup,

thre

e vi

site

d th

e w

ebsi

te. T

here

wer

e no

retu

rn v

isits

. In

tota

l jus

t 12

wom

en (5

5%)

retu

rned

for f

ollo

w-u

p, d

espi

te th

e ap

poin

tmen

t coi

ncid

ing

with

thei

r ant

enat

al a

nom

aly

scan

. N

one

of th

e w

omen

qui

t sm

okin

g. A

lthou

gh th

is R

CT

on sm

okin

g ce

ssat

ion

in p

regn

ancy

w

as u

nsuc

cess

ful,

we

repo

rt ou

r find

ings

bec

ause

we

belie

ve th

ere

are

lear

ning

poi

nts

for r

esea

rche

rs a

nd m

ater

nity

serv

ices

. We

foun

d th

at w

omen

who

are

per

sist

ent s

mok

ers

whe

n th

ey p

rese

nt fo

r hos

pita

l ant

enat

al c

are

have

littl

e in

tere

st in

qui

tting

. Alth

ough

the

inte

rven

tion

was

evi

denc

e-ba

sed,

cus

tom

ized

and

acc

essi

ble,

pat

ient

eng

agem

ent w

as p

oor.

Thos

e w

ho a

re n

ot m

otiv

ated

to q

uit a

ppea

r rel

ucta

nt to

seek

adv

ice,

how

ever

brie

f, or

to

acce

ss o

ngoi

ng o

nlin

e su

ppor

t, ho

wev

er c

usto

miz

ed.

FIGURES AND TABLES


92

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Sloa

n (2

017)

Tele

phon

e in

terv

iew

sPe

rcep

tions

of p

rogr

am,

smok

ing

abst

inen

ce o

r re

duct

ion

Preg

nanc

y-sp

ecifi

c ce

ssat

ion

supp

ort v

ia te

xt m

essa

ging

was

wel

l rec

eive

d an

d pa

rtici

pant

s in

dica

ted

that

the

supp

ort i

ncre

ased

thei

r mot

ivat

ion

to st

op sm

okin

g. P

artic

ipan

ts fe

lt te

xts

had

key

adva

ntag

es o

ver f

ace-

to-f

ace

supp

ort,

larg

ely

due

to th

e co

nven

ienc

e, th

e co

nsta

nt

pres

ence

, enc

oura

gem

ent a

nd lo

w-p

ress

ure

natu

re o

f the

text

s. A

t fol

low

-up,

five

par

ticip

ants

re

porte

d ab

stin

ence

from

smok

ing,

with

an

addi

tiona

l tw

o re

porti

ng q

uitti

ng p

ostp

artu

m. A

ll ot

her p

artic

ipan

ts re

porte

d cu

tting

dow

n

Stie

gler

(201

6)W

ebsi

te d

ata,

surv

ey, n

icot

ine

depe

nden

ce sc

ales

Onl

ine

plat

form

usa

ge,

smok

ing

abst

inen

ce ra

tes

32 o

f the

tota

l sam

ple

wom

en re

gist

ered

on

the

plat

form

dur

ing

the

cour

se o

f 20

wee

ks.

26 w

omen

met

the

crite

ria fo

r tob

acco

dep

ende

nce.

Thr

ee m

onth

s afte

r the

end

of t

he

prog

ram

, five

repo

rting

wom

en st

ated

that

ther

e ha

d be

en a

pos

itive

cha

nge

in th

eir t

obac

co

cons

umpt

ion

due

to th

eir p

artic

ipat

ion

in th

e on

line

prog

ram

. All

stat

ed th

at th

ey h

ad sm

oked

le

ss b

ecau

se o

f the

ir pa

rtici

patio

n an

d fo

ur p

artic

ipan

ts in

the

toba

cco

prog

ram

succ

eede

d in

st

oppi

ng sm

okin

g co

mpl

etel

y du

ring

preg

nanc

y. T

he fo

llow

-up

surv

ey in

the

3-m

onth

inte

rval

(n

= 5)

show

ed a

n ab

stin

ence

rate

in th

e to

bacc

o pr

ogra

m o

f 18.

5 %.

Tapp

in (2

015)

Bre

ath

CO

, Nic

otin

e de

pend

ence

sc

ale,

self-

repo

rt, c

otin

ine

leve

ls

(blo

od, u

rine

and

saliv

a)

Bio

chem

ical

ly v

erifi

ed

smok

ing

cess

atio

n, n

umbe

r ne

eded

to tr

eat (

for i

ncen

tive

effe

ctiv

enes

s)

Sign

ifica

ntly

mor

e sm

oker

s in

the

ince

ntiv

es g

roup

than

con

trol g

roup

stop

ped

smok

ing:

69

(22.

5%) v

ersu

s 26

(8.6

%).

The

rela

tive

risk

of n

ot sm

okin

g at

the

end

of p

regn

ancy

was

2.6

3 (9

5% c

onfid

ence

inte

rval

1.7

3 to

4.0

1) P

<0.0

01. T

he a

bsol

ute

risk

diffe

renc

e w

as 1

4.0%

(95%

co

nfide

nce

inte

rval

8.2

% to

19.

7%).

The

num

ber n

eede

d to

trea

t (w

here

fina

ncia

l inc

entiv

es

need

to b

e of

fere

d to

ach

ieve

one

ext

ra q

uitte

r in

late

pre

gnan

cy) w

as 7

.2 (9

5% c

onfid

ence

in

terv

al 5

.1 to

12.

2).

Uss

her (

2015

a)Su

rvey

s, ex

hale

d C

O, s

aliv

ary

cotin

ine,

acc

eler

omet

erSm

okin

g ab

stin

ence

rate

s, ph

ysic

al a

ctiv

ity ra

tes,

atte

ndan

ce to

trea

tmen

t se

ssio

ns, b

irth

outc

omes

No

sign

ifica

nt d

iffer

ence

was

foun

d in

rate

s of s

mok

ing

abst

inen

ce a

t end

of p

regn

ancy

be

twee

n th

e ph

ysic

al a

ctiv

ity a

nd c

ontro

l gro

ups (

8% v

6%

; odd

s rat

io 1

.21,

95%

con

fiden

ce

inte

rval

0.7

0 to

2.1

0). F

or th

e ph

ysic

al a

ctiv

ity g

roup

com

pare

d w

ith th

e co

ntro

l gro

up, t

here

w

as a

40%

(95%

con

fiden

ce in

terv

al 1

3% to

73%

), 34

% (6

% to

69%

), an

d 46

% (1

2% to

91

%) g

reat

er in

crea

se in

self-

repo

rted

min

utes

car

ryin

g ou

t phy

sica

l act

ivity

per

wee

k fr

om

base

line

to o

ne w

eek,

four

wee

ks, a

nd si

x w

eeks

pos

t-qui

t day

, res

pect

ivel

y. A

ccor

ding

to th

e ac

cele

rom

eter

dat

a th

ere

was

no

sign

ifica

nt d

iffer

ence

in p

hysi

cal a

ctiv

ity le

vels

bet

wee

n th

e gr

oups

. Par

ticip

ants

atte

nded

a m

edia

n of

four

trea

tmen

t ses

sion

s in

the

inte

rven

tion

grou

p an

d th

ree

in th

e co

ntro

l gro

up. A

dver

se e

vent

s and

birt

h ou

tcom

es w

ere

sim

ilar b

etw

een

the

two

grou

ps, e

xcep

t for

sign

ifica

ntly

mor

e ca

esar

ean

birth

s in

the

cont

rol g

roup

than

in th

e ph

ysic

al a

ctiv

ity g

roup

(29%

v 2

1%, P

=0.0

23).

Uss

her (

2015

b)Se

lf-re

port,

car

bon

mon

oxid

e an

d/sa

livar

y co

tinin

e, su

rvey

Smok

ing

cess

atio

n, p

hysi

cal

activ

ity le

vels

, birt

h ou

tcom

es

Supp

lem

entin

g be

havi

oral

supp

ort w

ith a

phy

sica

l act

ivity

(PA

) int

erve

ntio

n w

as n

o m

ore

effe

ctiv

e th

an b

ehav

iora

l sup

port

alon

e in

pro

mot

ing

smok

ing

cess

atio

n. T

hese

find

ings

w

ere

obse

rved

des

pite

the

phys

ical

act

ivity

gro

up se

lf-re

porti

ng 3

5–47

% g

reat

er in

crea

ses i

n ph

ysic

al a

ctiv

ity th

an th

e co

ntro

l gro

up d

urin

g th

e in

terv

entio

n pe

riod.

The

re w

as n

o ev

iden

ce

that

the

phys

ical

act

ivity

inte

rven

tion

incr

ease

d ad

vers

e ev

ents

or h

ad a

har

mfu

l effe

ct o

n bi

rth

outc

omes

and

ther

e w

as so

me

evid

ence

that

the

PA in

terv

entio

n re

sulte

d in

few

er c

aesa

rean

se

ctio

ns. I

n pr

egna

ncy,

the

phys

ical

act

ivity

inte

rven

tion

that

we

test

ed is

not

reco

mm

ende

d fo

r sm

okin

g ce

ssat

ion

but r

emai

ns in

dica

ted

for g

ener

al h

ealth

ben

efits

.

TABLE

5: C

ontin

ued

FIGURES AND TABLES


93

TABLE

5: C

ontin

ued

STU

DY

DAT

A S

OU

RCE

OU

TCO

ME

MEA

SURE

SST

UD

Y RE

SULT

S

Wen

(201

9)U

rine

cotin

ine,

self-

repo

rt ca

lend

ar

of c

igar

ette

use

Smok

ing

cess

atio

n,

parti

cipa

nt sa

tisfa

ctio

nA

rela

tivel

y hi

gh sm

okin

g ce

ssat

ion

rate

and

hig

h pa

rtici

patio

n sa

tisfa

ctio

n w

ere

foun

d. A

s hy

poth

esiz

ed, t

he sm

okin

g ce

ssat

ion

rate

in th

is st

udy

(63%

) was

rela

tivel

y hi

gher

than

the

rate

s in

our p

revi

ous t

rials

usi

ng c

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FIGURES AND TABLES


94

TABLE 6: LIMITATIONSSTUDY LIMITATIONS

Abroms (2017a) The study was not powered to detect differences in smoking-related outcomes, and unlike prior studies, none were detected. One final finding of note was that few participants—9% (7/80) of all participants—reported receiving extra treatment help in the form of help from the quitline. This was in spite of a clear effort to get all participants to call the quitline. Recruitment was a challenge. While the intervention was aimed at pregnancy cessation, by 3-month follow-up some women gave birth during the study period. It is unclear what the impact of the birth was on smoking behaviors. The study results may not be generalizable to all pregnant smokers as participants had the following characteristics: They had disclosed their smoking status to their medical provider, were from a mid-Atlantic metropolitan area, and on average were 21.42 weeks pregnant.

Abroms (2017b) This study had insufficient power with the sample size. Further, the intervention group was less responsive than controls for the 1 month follow up, resulting in more missing data in intervention group. Additionally, some participants in the control group sought outside quit support.

Abroms (2015) Out of the 409 women (Text4baby subscribers) who indicated they were interested in being part of the study (pilot testing of Quit4Baby), only 20 were found to be eligible. Of this number, 16 completed the 2-week follow-up survey (80% response rate), and 13 completed the 4-week follow up survey. Additional weaknesses include the lack of a control group and that participation may have been limited by some Text4baby subscribers’ unwillingness to disclose their smoking activity.

Bailey, S.R. (2017) This study was limited to an Oregon population of community health center patients, thus, results might not generalize to patients in other states or adults who seek care at non-community health centers. It could not be determined from the data which patients had providers who had registered and attested to meeting Centers for Medicare and Medicaid Services’ Meaningful Use (MU) of Electronic Health Record (EHR) Program measures; therefore, all adult patients who met study inclusion criteria were included. The denominator was limited to patients seen within each measurement year, whereas MU includes patients seen in the past 24 months; therefore, these findings should not be interpreted as a direct measure of MU performance.

Bailey, B.A. (2015) The use of an historical control group, instead of a current control group as part of a randomized controlled design, could have introduced additional differences between the two groups. All women were included in control group, but women in the intervention group chose to participate, introducing bias in results. A cigarette tax was introduced during the study period and could have had an effect on quit motivation or rates, and costly health educators (grant supported) may not be sustainable or replicable.

Bartholomew (2016) This study was limited by an inability to measure secondhand smoke exposure and the paucity of data on policy implementation and enforcement.

Bell (2018) We used routinely collected data from a number of different sources. Organizations collected different variables or defined variables differently, and these were combined and unified to provide a single measure of smoking status in pregnancy. Some variables had high levels of missing data. Thus, alternative explanations for the findings should be considered. There may have been changes in characteristics of the women over the study period and changes in responsibility for smoking cessation services. It was unable to be determined whether the effect of the intervention was sustained beyond 4 months, or postnatally in individual women. The intervention targeted behaviors at a number of levels across the healthcare system, both organizational and individual. It was not possible to identify specific aspects of this complex intervention which led to the observed changes, nor were the authors able to confirm whether the positive effects we observed were sustained. The finding that additional training sessions increased referrals suggests that repeated training may be required to prevent attenuation.

Brown (2016) This study used self-reported smoking behaviors without biochemical verification. The cross-sectional study design does not allow for assumptions about the temporal order of the variables, which limits causal inferences. Health insurance may not be the only or best measure of access to health care. Nicotine dependence and alcohol use disorders were not the focus of the use of the survey.

Buchanan (2017) This is an evaluation of a clinical tobacco cessation hospital service, and as such, data were not collected necessarily for research purposes, bedside consults and interviews were not standardized, and there was missing data from the electronic medical record. Second, post-discharge abstinence outcomes are self-reported and no biochemical confirmation of abstinence was collected. Third, given missing demographic information, it cannot be ensured that the analyzed sample was representative of the perinatal population of the hospital generally.

FIGURES AND TABLES


95

STUDY LIMITATIONS

Campbell (2017) Although CO validation was used to refer women to smoking cessation programs, cessation outcome was not CO validated but self-reported; errors in the data collection system found that a small number of women who should have been referred were not, and some data was not collected. The study was conducted in a limited geographic area so results may not be generalizable

Chertok (2015) This study had a small sample that was limited to a geographic region with relatively high prenatal smoking rates, minimizing generalization of results. Smoking behaviors were not biochemically verified and the self-reported smoking may have been subject to reporting bias. Women who participated in the study may also have been tending toward smoking cessation on their own.

Cummins (2016) No information was provided on participant demographics. It’s unclear where they reside and which quitlines(s) the participants called. No details on the smoking-cessation phone script specifically intended for pregnant women and the study was not designed to test the individual components of the telephone counseling nor compare it to the standard quitline counseling or to those who do not use quitlines. The return rate for biochemical validation of self-report was low (24.1%). Although there was no difference in the return rates between conditions, low rates limit conclusions about misreporting rates and increase the reliance on self-report

Eddy (2015) The sample size was small and the participants chose to be in the study and may not be representative of all pregnant smokers. The midwives used their discretion to judge the most appropriate time and frequency to raise the topic of smoking so the dosage of the intervention varied for each participant. Participants were enrolled at different times during the study, receiving differing lengths of the intervention.

England (2017) There is no data on exposure to the campaign at the individual level and it is not known what other smoking cessation exposures pregnant women had before, during, or after the campaign period. Similarly, there is no post campaign, unexposed population in which to determine whether cessation rates would return to pre-campaign levels. Other limitations include that quit status was not biochemically validated, which would be problematic if non-disclosure increased after the introduction of the Tips campaign. Our results apply to pregnancies ending in a live birth in three states and can’t be generalized to the US population or to pregnancies ending in miscarriage or stillbirth. Cessation rates in Kentucky increased disproportionately after Tips 2012 was aired compared with Ohio and Indiana supports that effects of the campaign may vary by state and Tips campaign could be more modest in states with lower smoking prevalence. Unlike the Tips 2013 campaign in which media markets were randomized to receive a higher or lower media buy, the national media buy for Tips 2012 was supplemented with broadcasts in smaller local television channels in media markets with high smoking prevalence. Thus, our finding that cessation was positively associated with media buy dose could be the result of confounding. It is unknown whether the 2012 Tips campaign was as effective among pregnant smokers as a campaign specifically targeting pregnant women would have been.

Fallin-Bennet (2019) Not randomized, not all participants completed the follow up in the postpartum phase, may have over representation of those who are more motivated to quit. There were also limitations regarding the analysis strategies employed in the statistical testing of assessment scores due to unbalanced baseline versus post intervention panels as well as small sample sizes, which means that statistical analysis had low power.

Forinash (2018) The study was underpowered to detect statistical differences due to slow enrollment and high dropout rates. Of the 49 randomized study participants, 13 withdrew and 6 were lost to follow-up. Compliance with the smoking cessation medication therapy, lack of a support system, and commitment to behavioral changes may also have been a barrier for the low-income patients in this study.

Glover (2016) The sample size was small and limited to a small geographic region with no comparison group. The amount and specific type of support by the community health workers was not assessed. A more robust study would be needed to understand the dosage of the support needed for increasing quit rates and test the transferability to other regions to determine efficacy.

Griffis (2016) The observational study design is subject to bias is estimates of program effect; self-reporting on birth certificates could have underrepresent actual smoking behaviors; and the analysis did not take dosage of this or other social service programs into consideration.

Hankins (2016) Because not all states report smoking information for all years, CA, FL, IN, SD, MI, and NY were dropped from the analysis and the smoking behaviors were self-reported and subject to inaccuracies.

Harris (2015) Small sample size, lack of follow up postpartum to see if effects lasted.

TABLE 6: Continued

FIGURES AND TABLES


96

STUDY LIMITATIONS

Havard (2018) There may have been other changes in the environment during the study period that contributed to changes in prevalence of smoking during pregnancy, perhaps to a different extent in different strata. Not able to account for this by including a geographical control because most of the antismoking activities were implemented nationally. While it is possible that changes in the smoking cessation support provided in antenatal care during the study period would have led to greater smoking cessation during pregnancy, quitting after conception would not have affected smoking as it was measured in the current study.

Jin (2018) The period of the intervention (12 weeks) was relatively short term and the 20 minutes of exercise was a relatively low dose of intervention. Participants in this study were not randomized to groups and did not receive additional interventions between the period of the treatment cessation and at delivery.

Lee (2015) There was a modest sample size with a relatively high rate of attrition, reducing power. There was potential sample bias because the sampling missed lower-income women who seek treatment later in pregnancy.

Lopez (2015a) Although there were significant reductions in the proportion of women with depression scale scores indicative of possible mild or moderate depression, it could not be confirmed that the intervention reduced the proportion of women meeting diagnostic criteria for depression. Also, the depression scale instrument used was not specifically developed for postpartum depression and the scale used may assesses general symptoms of pregnancy and early postpartum that are not necessarily related to depression and hence risks inflating depression rating.

Lopez (2015b) Generalization of results is difficult because the study conditions were not the same across the combined studies and the sample participants represented a self-selected group within a limited geographic area. It was not tested and is not known how well the incentives offered in these studies would work for a more diverse group of pregnant women who smoke.

Minian (2016) The sample size was a very small, self-selected group in a small geographic area and limited to the number of PREGNETS online forum bloggers who were available for follow-up. One participant who did not blog for 7 months before final survey created recall bias. Monetary incentives may have influenced motivation for participation or responses.

Morgan (2016) The participants were a small group who self-selected to participate, with each participant having a combination of individuals factors that influenced their participation and smoking behaviors beyond the study interventions of indoor air quality measurements.

Naughton (2017) Completeness of follow-up and biochemical validation rates were not optimal, potentially reducing statistical power although the women lost to follow up were considered still smoking. The sample was not representative and of unknown generalizability of findings to all pregnant smokers.

Olaiya (2015) The measures relied on self-reported smoking behavior data. There was no way to examine the effect of varying degrees of fidelity to the 5As implementation by the various trained clinics. There were no precise timelines as to when 5As training was completed and initiated in the individual WIC clinics (rounded to calendar year the 5As was reported to have begun). Clinics that received the 5As training were not randomly selected and results may not be generalizable to all Ohio WIC clinics or outside of Ohio.

Olson (2019) The study was nonrandomized and was limited to a rural, white population. The control group data was collected in 2013-14, while the Smoke-Free Moms data was gathered in 2015-2016. It’s hard to know which variables may have changed during that time period, such as changing counselors.

Passey (2018) There was no control group and the sample size was small and in a limited geographical area. One of the original study sites withdrew from the program and those who declined to participate in the program were not interviewed as to why/obtain their perspectives.

Patten (2019) The study had a small sample size of one geographic area of AK, limiting generalizability. The control group participants in the study were already enrolled in a quit program and may be different than general population of pregnant smokers/women.

Reynolds (2019) The researchers were unable to recruit the number of women needed to show effects of the intervention (They recruited 22 but needed 220 to be able to show statistical differences).

Sloan (2017) Small sample of 15 women elected to participate. Of 203 participants in the larger study, 112 were followed up at the end of pregnancy and 79 gave permission to be contacted for an interview. However, only 15 participants were ultimately interviewed.

TABLE

4: C

ontin

ued

TABLE 6: Continued

FIGURES AND TABLES


97

STUDY LIMITATIONS

Stiegler (2016) This study had a small sample size and did not survey or interview those that dropped out to determine why. The outcome data relied on self-report surveys or measures.

Tappin (2015) Limited geographic area and the economic analysis included uncertainty because of postnatal relapse in some participants. There were a high number of losses to follow up.

Ussher (2015) Low attendance may have affected the outcomes. Women in the physical activity group attended a median of only four of 14 sessions. Evidence for the intervention influencing processes that might aid cessation, such as confidence for quitting, urges to smoke, or withdrawal symptoms was lacking; reliance on some self-reported exercise and smoking behaviors.

Ussher (2015b) Despite extending the recruitment period, the study team recruited only 91% of the target population. Quit rates were lower than anticipated in the power calculation, which also reduced the power of the study.

Wen (2019) Small sample size threatens the reliability of results including the estimated smoking cessation rat. The generalizability of findings might be limited because all participants were recruited from only one geographic area and all participants were of a similar age range. There was no control group to fully control for other factors that might affect smoking cessation such as participation attention and time. It was challenging to separate out the individual effect of each component of the multicomponent intervention. A considerable proportion of participants did not complete all the scheduled repeated baseline visits due to spontaneous quitting, pre-term delivery, miscarriage, or unknown reason. While patient satisfaction at the post-test was very positive, it needs to be interpreted with caution, given a substantial proportion (30%) did not respond to the satisfaction evaluation question.

Zvorsky (2015) Use of a secondary analysis of four trials conducted with other aims makes the results vulnerable to potential biases. The authors did not include a diagnostic instrument and therefore cannot determine what proportion of women met formal criteria for depression. The depression scale used was not specifically for postpartum depression.

TABLE 7: INDIVIDUAL EVIDENCE RATINGSSTUDY INTERVENTION TYPE/INTERVENTION COMPONENTS


Naughton (2017) Psychosocial: Counseling

Tappin (2015) Psychosocial: Incentives

MODERATE EVIDENCE

Abroms (2017b) Psychosocial: Health education + Incentives

Bailey B.A. (2015) Psychosocial: Counseling

Bell (2018) Psychosocial: Health care provider training

Berlin (2014) Pharmacotherapy: Nicotine replacement therapy

Cummins (2016) Psychosocial: Counseling

England (2017) Population-based: Policy

Forinash (2018) Psychosocial: Health education

Griffis (2016) Psychosocial: Multicomponent

Lee (2015) Psychosocial: Counseling

Lopez (2015a) Psychosocial: Incentives

Olaiya (2015) Psychosocial: Multicomponent

Zvorsky (2015) Psychosocial: Incentives

TABLE 6: Continued

FIGURES AND TABLES


98

STUDY INTERVENTION TYPE/INTERVENTION COMPONENTS

EMERGING EVIDENCE

Abroms (2017a) Psychosocial: Health education + Incentives

Abroms (2015) Psychosocial: Health education + Social support

Buchanan (2017) Psychosocial: Automatic initiation of smoking cessation program

Campbell (2017) Psychosocial: Automatic initiation of smoking cessation program

Chertok (2015) Psychosocial: Health care provider training

Coleman-Cowger (2018) Psychosocial: Counseling

Eddy (2015) Psychosocial: Counseling

Fallin-Bennett (2019) Psychosocial: Counseling

Glover (2018) Psychosocial: Social support

Harris (2015) Psychosocial: Counseling + Incentives + Feedback

Minian (2016) Psychosocial: Journaling

Morgan (2016) Psychosocial: Feedback

Olson (2019) Psychosocial: Incentives

Passey (2018) Psychosocial: Incentives

Patten (2019) Psychosocial: Counseling

Sloan (2017) Psychosocial: Counseling

Stiegler (2016) Psychosocial: Counseling

Ussher (2015a) Psychosocial: Exercise

Wen (2019) Psychosocial: Incentives

MIXED EVIDENCE

Bailey S.R. (2017) Psychosocial: Automatic initiation of smoking cessation program

Bartholomew (2016) Population-based: Policy

Brown (2016) Population-based: Policy

Havard (2018) Population-based: Policy

Lopez (2015b) Psychosocial: Incentives

EVIDENCE AGAINST

Hankins (2016) Population-based: Policy

Jin (2018) Psychosocial: Exercise

Reynolds (2019) Psychosocial: Counseling

Ussher (2015b) Psychosocial: Exercise

TABLE 7: Continued

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