development and validation of a pregnancy symptoms inventory · development and validation of a...

Development and Validation of a Pregnancy Symptoms Inventory

by

Kaye “Katie” Frances Foxcroft RN, RM

A thesis submitted in partial fulfilment of the requirements for the degree of

Masters of Applied Science- Research

School of Human Movements Faculty of Health

Queensland University of Technology

2010


i

Abstract

BACKGROUND. Physical symptoms are common in pregnancy and are

predominantly associated with normal physiological changes. These

symptoms have a social and economic cost, leading to absenteeism from

work and additional medical interventions. There is currently no simple

method for identifying common pregnancy related problems in the antenatal

period. A validated tool, for use by pregnancy care providers would be useful.

AIM: The aim of the project was to develop and validate a Pregnancy

Symptoms Inventory for use by healthcare professionals (HCPs).

METHODS: A list of symptoms was generated via expert consultation with

midwives and obstetrician gynaecologists. Focus groups were conducted

with pregnant women in their first, second or third trimester. The inventory

was then tested for face validity and piloted for readability and

comprehension. For test-re-test reliability, it was administered to the same

women 2 to 3 days apart. Finally, outpatient midwives trialled the inventory

for 1 month and rated its usefulness on a 10cm visual analogue scale (VAS).

The number of referrals to other health care professionals was recorded

during this month.

RESULTS: Expert consultation and focus group discussions led to the

generation of a 41-item inventory. Following face validity and readability

testing, several items were modified. Individual item test re-test reliability was

between .51 to 1 with the majority (34 items) scoring ≥0.70. During the

testing phase, 211 surveys were collected in the 1 month trial. Tiredness


ii

(45.5%), poor sleep (27.5%) back pain (19.5%) and nausea (12.6%) were

experienced often. Among the women surveyed, 16.2% claimed to

sometimes or often be incontinent. Referrals to the incontinence nurse

increased > 8 fold during the study period. The median rating by midwives of

the ‘usefulness’ of the inventory was 8.4 (range 0.9 to 10).

CONCLUSIONS: The Pregnancy Symptoms Inventory (PSI) was well

accepted by women in the 1 month trial and may be a useful tool for

pregnancy care providers and aids clinicians in early detection and

subsequent treatment of symptoms. It shows promise for use in the research

community for assessing the impact of lifestyle intervention in pregnancy.


iii

Keywords

Pregnancy Symptoms

Inventory

Survey

Questionnaire

Checklist


iv

Table of contents

Abstract ...................................................................................................i

Keywords............................................................................................... iii

Table of contents ................................................................................... iv

List of figures ........................................................................................ vii

List of tables ........................................................................................ viii

List of supplementary materials ............................................................. ix

Abbreviations..........................................................................................x

1 BACKGROUND......................................................................... 1

1.1 Research Aims........................................................................... 2

1.2 Research Questions .................................................................. 2

1.3 Hypotheses ................................................................................ 3

2 LITERATURE REVIEW ............................................................. 4

2.1 Nausea and Vomiting................................................................. 4

2.2 Fatigue....................................................................................... 5

2.3 Back pain ................................................................................... 6

2.4 Incontinence............................................................................... 7

2.5 Sleep Disturbances.................................................................... 8

2.6 Psychosocial Variables .............................................................. 9

2.7 Existing instruments................................................................. 10

3 APPROACH TO THE DEVELOPMENT AND TESTING OF THE

INVENTORY............................................................................ 15

3.1 Development............................................................................ 15

3.2 Interviews................................................................................. 15

3.3 Focus Groups .......................................................................... 16

3.3.1 Advantages .............................................................................. 17

3.3.2 Limitations................................................................................ 17

3.4 Designing Instruments ............................................................. 17

3.5 Testing ..................................................................................... 18

4 METHODS............................................................................... 20

4.1 Design...................................................................................... 20


v

4.2 Aims ......................................................................................... 20

4.3 Participants and setting ............................................................ 20

4.4 Procedure................................................................................. 20

4.4.1 Phase 1 (Expert consultation) .................................................. 21

4.4.2 Phase 2 (Focus groups) ........................................................... 21

4.4.3 Reconciliation of Data .............................................................. 23

4.4.4 Phase 3 (development and testing).......................................... 23

4.4.4.1 Face Validity............................................................................. 23

4.4.4.2 Test re-test ............................................................................... 25

4.4.4.3 Midwives perception of the usefulness of the inventory ........... 26

4.4.4.4 Practical use (Administration of the Inventory) ......................... 27

4.5 Ethical Considerations.............................................................. 28

5 ANALYSIS ............................................................................... 30

5.1 Development of inventory:........................................................ 30

5.1.1 Phase 1: Expert consultation.................................................... 30

5.1.2 Phase 2: Focus groups ............................................................ 30

5.1.3 Phase 3: Validating and testing the Inventory .......................... 30

5.1.3.1 Face validity ............................................................................. 30

5.1.3.2 Test re-test ............................................................................... 31

5.1.3.3 Usefulness of the inventory ...................................................... 31

5.1.3.4 Practical use............................................................................. 31

6 RESULTS................................................................................. 33

6.1 Phase 1 (Expert healthcare professionals consultation)........... 33

6.2 Phase 2 (Focus Groups) .......................................................... 34

6.3 Phase 3 Validating and testing the inventory............................ 34

6.3.1 Face validity (midwives) ........................................................... 34

6.3.2 Face validity (Comprehension and readability of the inventory by

pregnant women) ..................................................................... 35

6.3.3 Test re-test ............................................................................... 35

6.3.4 Usefulness of the inventory ...................................................... 37

6.3.5 Practical use............................................................................. 38

6.3.5.1 Characteristics of Respondents................................................ 38

6.3.5.2 Frequency of symptoms ........................................................... 39


vi

6.3.5.3 Relationships between symptoms and referrals....................... 43

7 DISCUSSION........................................................................... 46

7.1 Questionnaire Development..................................................... 46

7.2 Hypotheses .............................................................................. 52

7.3 Midwives Attitudes and Practice Change................................. 53

7.4 Limitations................................................................................ 54

7.5 Implications for Practice ........................................................... 56

7.6 Implications for Pregnant Women ............................................ 56

7.7 Recommendations for Research.............................................. 57

7.8 Conclusions ............................................................................. 58

References ........................................................................................ 101


vii

List of figures

Figure 1 Framework for the development and testing of the PSI.. 19

Figure 2 Incontinence referrals from Maternity Outpatients .......... 45


viii

List of tables

Table 1 Comprehension and readability of inventory (n=10)....... 25

Table 2 Symptoms identified by healthcare professionals (e) and

women (f) ....................................................................... 33

Table 3 Test re-test results for 23 women in Maternity Outpatients36

Table 4 Visual Analogue Scale and if PSI prompted referral and

associated comments (Midwife Survey) ......................... 38

Table 5 Demographics of surveyed women (n=211 unless otherwise

stated) ............................................................................ 39

Table 6 Prevalence of self reported often or sometimes experienced

pregnancy symptoms as a proportion of valid responses.41

Table 7 Prevalence of self-reported limitation as a proportion of those

women who reported experiencing the symptom. .......... 42

Table 8 Statistically significant relationships between symptoms and

referrals from the inventory (n=211) ............................... 43

Table 9 Proportion of referrals by midwives documented on

Pregnancy Symptom Inventory (n = 211)....................... 44


ix

List of supplementary materials

Appendix 1 Prevention of Gestational Diabetes ................................ 60

Appendix 2 Exercise in obese pregnant women: The role of social

factors, lifestyle and pregnancy symptoms..................... 64

Appendix 3 Letter of Invitation .......................................................... 88

Appendix 4 Survey of Midwives who used the PSI............................ 89

Appendix 5 Inventory completed by women included in the study .... 91

Appendix 6 Permission from the Ethics Committee........................... 94

Appendix 7 Participation Information and Consent Form .................. 97


x

Abbreviations

PSI Pregnancy Symptoms Inventory

RBWH Royal Brisbane and Women’s Hospital

HCP Healthcare Professional

HCW Healthcare Worker

VAS Visual Analogue Scale

ADLs Activities of daily living

MOPD Maternity Outpatient Department


xi

Authorship

The work contained in this thesis has not been previously submitted to meet

requirements for an award at this or any other higher education institution. To

the best of my knowledge and belief, the thesis contains no material

previously published or written by another person except where due

reference is made.

Signature

Date


1

1 BACKGROUND

Physical symptoms are common in pregnancy and are predominantly

associated with normal physiological changes that occur during this time.

Much of the literature reports on one or two specific symptoms and does not

look at pregnancy in its entirety (Attard et al., 2002; Behrenz & Monga, 1999).

To the best of the author’s knowledge there is currently no available

pregnancy specific symptoms inventory. There are reasons to believe that

such an instrument is needed. Designing a pregnancy symptoms inventory,

which acts as a risk assessment tool, assessing not only the prevalence of

symptoms but the frequency and severity, may be helpful in assessing which

women would benefit from early detection and treatment of pregnancy

symptoms. These symptoms have a social and economic cost as they are

responsible for absenteeism from work and additional medical interventions

(Doran et al., 2001; Noren et al., 1997). The basis of this study is an

assumption that early detection and treatment of symptoms will reduce the

severity of their impact on women’s quality of life and their activities of daily

living such as ability to work. In turn, this may minimize the impact to the

health care system and the Australian economy.

This need was confirmed in an earlier study that this author project managed

at The Royal Brisbane and Women’s Hospital (RBWH). This was an

investigation of the feasibility issues for an exercise intervention in obese

pregnant women that found a number of issues, which prevented women

from fully participating in their exercise intervention (Callaway et al., 2010).

The investigators suggested that an instrument, which could measure the


2

impact of pregnancy symptoms and other sociodemographic variables, would

have been useful in this lifestyle intervention program. See Appendix 1.

Subsequently a secondary analysis of the data revealed that women who

reported no nausea and vomiting and who had no lower back pain were

those women who were most likely to have exercised in early pregnancy

(Foxcroft et al., 2010). See Appendix 2.

The current study was conducted at The Royal Brisbane and Women’s

Hospital (RBWH), a large tertiary referral hospital caring for many of the

State’s more complicated pregnancies. Approximately 5000 pregnant women

per year attend the hospital’s busy Maternity Outpatient department. This

high throughput impacts on the time available for staff to fully explore issues

the pregnant woman may wish to discuss. Development of a Pregnancy

Symptoms Inventory, which could be completed whilst waiting to be seen by

their midwife or doctor, may aid in pinpointing particular problems the woman

is experiencing with her pregnancy. Some symptoms, such as incontinence,

may be embarrassing for the woman to talk about face to face. The ability to

fill in a checklist would be an easier way to broach the subject.

1.1 Research Aims

The aim of the project was to develop and validate a Pregnancy Symptoms

Inventory for use by healthcare professionals (HCPs).

1.2 Research Questions

a) What pregnancy signs and symptoms are reported by healthcare

professionals (HCPs)?

b) Are additional signs and symptoms reported by patients?


3

c) Can these signs and symptoms be combined in a Pregnancy Symptoms

Inventory that would grade severity and be useful to health workers who

provide care to pregnant women?

d) Does the use of a Pregnancy Symptoms Inventory result in an increase in

referrals to appropriate service providers?

1.3 Hypotheses

That a Pregnancy Symptoms Inventory, when used as part of a standard

prenatal visit, will be useful to healthcare professionals (HCPs).

That a Pregnancy Symptoms Inventory will identify, and be able to

discriminate between mild conditions and those requiring intervention.


4

2 LITERATURE REVIEW

A review of the available literature identified a variety of pregnancy

symptoms. Thirty eight discrete symptoms have been described (Zib et al.,

1999), with five being reported most frequently. These are: frequency of

micturition (passing urine), fatigue, pelvic pressure, insomnia and lower

backache. However, pregnancy symptoms are not always experienced in

isolation. There are many studies that have investigated a small number of

pregnancy symptoms (Jomeen et al., 2005; O’Brien & Naber, 1992; Smith et

al., 2006) although the interaction of symptoms, such as back and pelvic pain

causing sleep disturbances or sleep disturbances causing fatigue are less

well explored. Psychosocial variables also impacts on the variance in the

prevalence and frequency of a variety of pregnancy symptoms (Rodriguez et

al., 2001).

The following review focuses on the most common symptoms experienced

by women during pregnancy to gain an understanding of the level and quality

of research in these areas.

2.1 Nausea and Vomiting

Approximately 70% of all pregnant women experience nausea and vomiting

to some degree in their first trimester (Jomeen et al., 2005). For 50% of these

women, this will resolve by the 14th week of their pregnancy. However it was

not until gestational week 22 that nausea had resolved in 90% of affected

women in a prospective study of 160 women using daily self-recording of

symptoms and the McGill Nausea Questionnaire (Lacroix et al., 2000). This

same study demonstrated that nausea and vomiting experienced by pregnant


5

women was comparable to what is thought to be the worst nausea, that of

cancer chemotherapy (Lacroix et al., 2000).

The term “morning sickness” can be misleading as many studies have shown

that symptoms can happen at anytime of the day or night (Dilorio et al., 1992;

Gadsby, 1994; Lacroix et al., 2000; van Lier et al., 1993). One study reported

29% of women had symptoms severe enough to alter their daily activities

(O’Brien & Naber, 1992). It has been reported that women who experience

frequent nausea and vomiting feel more depressed than those without these

symptoms – this positive correlation was seen in a study of 113 participants

by (Chou et al., 2003) and supported by findings from (Reeves et al., 1991).

Another study of women showed the more severe the vomiting or the

retching in early pregnancy, the longer the symptoms lasted and this

increase in vomiting was associated with decreased infant birth weight (Zhou

et al., 1999). Zhou’s study also found there are effective and commonly used

palliative measures which can be suggested by the midwife or doctor

including rest, eating carbohydrates and drinking carbonated drinks -of note

20% of participants had not tried these measures indicating that suggesting

these methods to women with severe vomiting may be beneficial.

2.2 Fatigue

Studies report that the most common barrier to exercise in pregnancy is

fatigue (Symons Downs & Ulbrecht, 2006). In a study of 476 Scandinavian

nulliparous women, fatigue was experienced by over 90% of the sample

throughout the pregnancy (Rodriguez et al., 2001). In Behrenz and Monga’s

(1999) study they showed that pregnant women experienced significantly


6

greater fatigue than a similar non-pregnant group of women. Some studies

have shown that fatigue increased in the third trimester (Elek et al., 1997;

Fawcett & York, 1986) whilst other studies showed a greater level of fatigue

in the first trimester (Affonso et al., 1990; Paarlberg et al., 1996).

Fatigue has been shown to be an important factor associated with antenatal

morbidity (Luke et al., 1999). In one study of 633 women who were 20-36

weeks pregnant, the prevalence of fatigue was 94.6% and their fatigue

scores were significantly associated with caesarian deliveries. Interestingly

women who did not work outside the home in this study had significantly

higher fatigue scores than women who did sedentary work (Chien & Ko,

2003). However, the study did not speculate or provide data to explain this

finding, subsequently, it may be an are for future research

Many women suffer from a lower haemoglobin during pregnancy and this

may lead to feelings of fatigue which can be helped with the aid of an iron

supplement (Beischer & Mackay, 1988) . There has also been research

which indicates that nausea and vomiting are correlated with fatigue

(FitzGerald, 1984; van Lier et al., 1993) and this finding supports the notion

that many pregnancy symptoms should not be looked at in isolation.

2.3 Back pain

Low back pain and pelvic pain are common among pregnant women with

reported rates between 55–75% (Kristiansson et al., 1996; Mogren &

Pohjanen, 2005; Orvieto et al, 1994; Pool-Goudzwaard, 2005). One study

found a significantly greater occurrence of pelvic floor dysfunction in women

suffering pregnancy-related lower back pain or pelvic pain. This finding is


7

supported by Smith (2006) who found a strong association between

incontinence and back pain (Smith et al., 2006). The average sick leave due

to back pain in pregnancy is seven weeks in Sweden (Noren et al., 1997);

this equates to substantial economic cost. Back pain in pregnancy is

treatable. Women with back pain may be referred to a physiotherapist for

core stability training or water gymnastics as there is good evidence that

these strategies can reduce back pain in pregnancy (Pennick & Young, 2007)

2.4 Incontinence

Urinary incontinence is a common complaint in pregnancy (Eliasson et al.,

2005). In a study of 665 primiparous women, the incidence of urinary leakage

was 62%. A substantial number of women complain that urinary symptoms

affect their quality of life (QOL) to some degree. In one study, which used the

International Prostate Symptom Score (IPSS), approximately half of the

pregnant women reported that they were mostly dissatisfied because of their

urinary symptoms. The instrument is not gender specific but simply aims to

quantify the severity of symptoms and the impact of urinary symptoms on

their quality of life (Aslan et al., 2003).

The total annual cost of urinary incontinence in Australia has been estimated

at $710 million (Doran et al., 2001). There is strong evidence that pelvic floor

exercises performed during and after pregnancy can prevent urinary

incontinence. One Australian study that investigated over 30,000 women in

differing age groups found that one in three mid-age and older women

experience leaking urine and that it was significantly associated with parity.

This study suggested, as less than half of these women had sought help, that

it is an issue which should be brought up during their antenatal care (Chiarelli


8

& Brown, 1999). Available evidence indicates, because incontinence is a

somewhat embarrassing subject socially, that patients and medical

practitioners alike are reticent about discussing it (Chiarelli, 2004).

The pregnancy symptoms inventory could be used to flag such problems;

patients who are uncomfortable bringing up the topic may find it easier to

“tick a box”, to alert their midwife or doctor that they are experiencing

problems in this area.

2.5 Sleep Disturbances

Sleep disturbances are common in pregnancy (Mindell & Jacobson, 2000;

Sahota et al., 2003; Santiago et al., 2001) and are thought to be caused by a

number of factors including physiological, hormonal, and physical changes

associated with pregnancy (Santiago et al., 2001). Sleep disturbances are

most prevalent in the third trimester (Sahota et al., 2003). One study showed

an increase in specific awakenings of 63% in the first trimester, 80% in the

second trimester and 84% in the third trimester (Lopes et al., 2004). One

explanation for the increase in maternal wakefulness in the third trimester

was the correlation between foetal activity and the increased number of

maternal awakenings during sleep (Worth et al., 2002).

Sleep disturbances range from insomnia and excessive nocturnal

awakenings, to restless leg syndrome and snoring (Pien & Schwab, 2004;

Sahota et al., 2003). Decreased haemoglobin levels and deficits of iron and

vitamins were found to be risk factors for restless leg syndrome (TunÃ§ et al.,

2007). Other factors such as increased BMI and the development of

preeclampsia may contribute to sleep disturbances such as snoring (Sahota


9

et al., 2003). Some of these symptoms for example incontinence (Chiarelli,

2004) and back pain (Pennick & Young, 2007) can be minimised by early

intervention.

2.6 Psychosocial Variables

Many symptoms during pregnancy can impact on the health and well being of

both mother and baby and may be exacerbated by emotional issues. One

study showed that stress not only contributed to prevalence and frequency of

concurrent symptoms but also predicted symptoms for up to 16 weeks later

and was more predictive than medical risk, smoking or weight gain

(Rodriguez et al., 2001). In another study depressive symptoms were

associated with physical complaints in early pregnancy but the author stated

that it was unclear “whether depressive symptoms and social support

preceded the physical symptoms or resulted from them” (Chou et al., 2003).

Other studies have reported women in early pregnancy with depressive

symptoms have poor health-related quality of life and suggest that early

identification and management may improve their sense of well being

(Nicholson et al., 2006).

Although pregnancy symptoms have been reported by numerous authors,

questions and data collection methods vary considerably between studies.

This may be due to the lack of a standardised tool for reporting the frequency

and severity of pregnancy symptoms. Some of the tools used for this purpose

are discussed below.


10

2.7 Existing instruments

There are many health related questionnaires, surveys, checklists and

inventories designed to uncover particular health issues. Self- administered

questionnaires are the most practical, efficient, and inexpensive method of

obtaining patient-based information (Hajebrahimi et al., 2004).

The McGill Nausea Questionnaire was developed and evaluated by

(Melzack et al., 1985) in response to the need for a valid and reproducible

measure to evaluate therapies for nausea induced by cancer chemotherapy.

The questionnaire consists of three indexes of nausea, two quantitative and

one qualitative. The quantitative components consist of an overall nausea

index based on a scale 0 to 5 and a visual analogue scale. The qualitative

measure consisted of sets of verbal affective and other descriptors of

nausea, with each set ranked in order of severity (Lacroix et al., 2000). This

questionnaire has been found to be a sensitive measure of the nausea and

vomiting produced by chemotherapy drugs (Melzack et al., 1985). The McGill

Nausea Questionnaire takes 2 -3 minutes and was completed weekly.

However the overall nausea index was used for the detailed daily nausea

ratings in the Lacroix et al (2000) study of 160 women who provided daily

recordings of frequency, duration and severity of nausea and vomiting which

gave more in depth detail.

In another study looking at the severity of nausea and vomiting during

pregnancy the Rhodes Index of Nausea and Vomiting – Form 2(INV2) was

used (Zhou et al., 1999). This is an 8-item, Likert-type, self report instrument

that measures degree and duration of nausea, vomiting and retching

(Rhodes et al., 1984). This 5 - point scale ranged from 1 (no symptoms) to 5


11

(severe symptoms). Although there are limitations to self report

questionnaires the reliability and validity of the instrument has been

supported in other studies (Zhou et al., 1999).

The Fatigue System Checklist (FSC) was first developed to measure

fatigue in Japanese industrial workers (Yoshitake, 1978) and was later

revised to measure fatigue in new mothers of full term infants (Milligan et al.,

1997). The FSC was scored as a total scale, comprising of 30 items with

(yes/no) responses and scored 0-30. A high FSC score indicates greater

fatigue. In Milligan et al’s study of 285 mothers the internal consistency was

0.82-0.95 at three time periods. Construct validity was shown by the positive

association between fatigue scores and depression, multiparity, infant

difficulty and less sleep at three time periods. Internal consistency of the FSC

was 0.89 as assessed by Cronbach’s alpha (Chien & Ko, 2003).

The Pearson – Bryars Fatigue Feeling Checklist (PBFFC) is a self

reported scale that measures fatigue at six times during the previous day;

starting with “upon wakening” and finishing with “just before retiring”.

Responses range from 1, “extremely peppy” to 10, “ready to drop,” total

scores range from 6-60. The reported coefficients of reproducibility of

individual items on the scale exceeded or approached the 0.90 acceptance

level, and the coefficient of scalability was 0.71 (van Lier et al., 1993).

In a 2002 review of five low back disability questionnaires the modified

Oswestry Disability Questionnaire, the Quebec Back Pain Disability

Scale, the Roland-Morris Disability Questionnaire, the Waddell

Disability Index, and the SF-36 Physical Functioning Scale (SF-36) were


12

compared in patients undergoing physical therapy for low back pain. The aim

of the study was to compare the reliability of the five low back pain disability

measurements in an ambulatory clinical population seeking physical therapy

for low back pain in hospital outpatient departments, community clinics, and

private practices. The review found that the measurements using the

modified Owestry Disability Questionnaire, the SF-36 Physical Functioning

Scale, and the Quebec Back Pain Disability Scale were the most reliable and

had sufficient width scale reliability to detect improvement or worsening in

most subjects. The reliability of measurements with the Waddell Disability

Index was moderate but the scale appeared to be insufficient to recommend

its use clinically. The Roland – Morris Disability Questionnaire and the Role

Limitations – Physical and Bodily Pain Scales of the SF-36 lacked sufficient

reliability and scale width for clinical use (Davidson & Keating, 2002).

The International Consultation on Incontinence Questionnaire short

form (ICIQ-SF) is a short questionnaire (five questions) proposed by the

World Health Organisation Consultation on Incontinence, with the aim of

providing an easy to use set of modules covering the assessment of urinary

incontinence severity and its impact on quality of life (Hajebrahimi et al.,

2004). The administration time is approximately 3.5 minutes (Abdel-Fattah et

al., 2007). This questionnaire was used in a study of 64 women consulting for

urinary incontinence. They were asked to complete the ICIQ-SF three times;

twice during the same visit, by self administration and physician interview,

and once at home approximately one week later. The study demonstrated

that information obtained through self administration at the office, at home, or

by the physician was not different (Hajebrahimi et al., 2004). The sensitivity,


13

validity and reliability of the ICIQ-SF have been confirmed in other studies, it

showed moderate correlation with the Kings Health questionnaire and Bristol

female lower urinary tract symptoms “quality of life factor” questionnaires

(Avery et al., 2004).

The Incontinence Bothersome Scale (IBS) was developed to see if a

simple visual analogue scale (VAS) which takes only a few seconds to

complete, can reliably assess the quality of life in women with urinary

incontinence (Abdel-Fattah et al., 2007). When compared to the Kings

Health Questionnaire (KHQ) which is a validated and reliable questionnaire

in urogynaecology research, results showed poor correlation between the

IBS and KHQ scores (Abdel-Fattah et al., 2007). The author of the study

concluded that it was difficult for the physician and the patients to summarize

all the adverse effects of urinary incontinence into a single score on the VAS

(Abdel-Fattah et al., 2007).

The Sleep and Health Questionnaire (SHQ) and the Epworth Sleepiness

Scale (ESS) are two methods of evaluating sleep disturbances. The SHQ

contains 16 questions grouped into five factors (functional impact of

sleepiness, self reported breathing disturbances, roommate-observed

breathing disturbances, driving impairment, and insomnia), which have been

useful in predicting sleep apnoea.

The ESS is a measure of daytime sleepiness. This self administered

questionnaire asks subjects to rate on a scale of 0 - 3 the chance they would

fall asleep or doze off in eight common situations in life, giving a total score


14

out of 24. Both these questionnaires are subjective assessments of

sleepiness form slightly different angles (Leung et al., 2005).

This overview of existing instruments demonstrates the complexity of

pregnancy symptoms and ways of measuring them. However, despite the

availability of many instruments, they all deal with only one pregnancy

problem. There is no instrument that evaluates all pregnancy symptoms at

the same time. Zib’s 1999 study was an interviewer administered study

aimed at determining the nature and range of symptoms occurring in normal

pregnancy. This study however did not look at severity and affect the

symptoms had on the woman’s activities of daily living (ADL’s).

One approach would be to combine the best of the discrete symptom

questionnaires into one tool. However, this would make any such

questionnaire too lengthy for any practical application. The other approach;

the one adopted here, is to develop a completely new instrument, one based

on investigating issues that women experience, using qualitative methods.

Any such instrument should incorporate degrees of severity to be useful to

clinicians. They should also be shown to be valid, reliable and acceptable to

clinicians.


15

3 APPROACH TO THE DEVELOPMENT AND

TESTING OF THE INVENTORY

3.1 Development

A check list or inventory has been defined as “a type of informational job aid

used to reduce failure by compensating for potential limits of human memory

and attention” (http://en.wikipedia.org/wiki/Checklist). It differs from scales or

indices, which use several related questions to measure one concept or

variable (Drewes, 2009). However, the development of an inventory follows

many of the same stages as those used in the development of most new

instruments; that is literature reviews, in-depth interviews and focus group

interviews. The literature review is an important first step, it provides

information about what is known and can be used to identify information

gaps. Interviews and focus group sessions are used to provide additional

information. They should include all relevant key stakeholders because it has

been shown that the beliefs may differ between groups or representatives of

groups (Maczka et al., 2009).

3.2 Interviews

Interviews can be conducted in an unstructured or structured way. Less

structured interviews may be useful in a preliminary survey , where the

purpose is to obtain information to help in the subsequent planning of a study

(Abramson & Abramson, 1999).However interviews are difficult to do well

and require considerable time and energy (Liamputtong & Ezzy, 2006).


16

3.3 Focus Groups

Focus groups are another method of collecting information and usually

consist of between 6-10 participants (Krueger, 1994).Multiple groups up to

fifty may be used however usually just a few are needed (Kitzinger,

1995).The number of focus groups is determined by the information which is

gathered, when no new themes are coming forward saturation has been

reached.

The aim is for a homogeneous group (similar age, gender, education, ethnic

background and life experiences) to capitalise on shared experiences whilst

still having some diversity in the group to get a cross section of opinion

(Ivanoff & Hultberg, 2006).

The environment needs to be trusting, non-judgemental and encourage self

disclosure. This enables people who are reluctant to express their views in a

one on one interview to feel more supported in a focus group. Participants

are chosen for their knowledge on the topic which often empowers them as

they feel like an expert on the topic. The facilitator has to be careful not to

lead the discussion or reinforce existing expectations and make it clear that

they are there to hear from the participants who should be discussing the

topic between the group members and not directly addressing the facilitator

(Sim, 1998). The facilitator also needs to be empathetic and have good

listening skills (Ivanoff & Hultberg, 2006) whilst striking a delicate balance

between involvement and too much involvement. It has been suggested no

more than 5%-10% of the transcript should be the words of the facilitator

(Hague, 1993) and that having a second researcher in the room is useful in

picking up any undue prompting (Sim, 1998).


17

3.3.1 Advantages

Focus groups allow for a greater spontaneity and are more economical than

one-on-one interviews. They provide a “safe” forum as participants don’t

have to answer every question (Sim, 1998). Participants who cannot read or

write or who have other specific difficulties are not discriminated against

(Robinson, 1999; Sim, 1998). Focus groups may give participants support

and empower them by a sense of group membership. Kitzinger (1995) says

“focus groups reach the parts that other methods cannot”. This method of

data collection is sensitive to cultural variables and can identify shared and

common knowledge.

3.3.2 Limitations

Focus groups rely on group dynamics and are central to their success;

however, dominant articulate members of the group can suppress the less

self confident or less articulate group members from expressing alternate

view points (Kitzinger, 1995; Sim, 1998). Other limitations include the

compromised confidentiality of group members in a focus group; this could

mean if the topic is sensitive the participants may not want to reveal their

thoughts or personal backgrounds.

3.4 Designing Instruments

Items or questions generated through the development process may be

either open-ended or closed-ended and there are advantages and

disadvantages to both. The open-ended question gives the participant more

scope to report richer information than a discrete list of answers will, however

the responses may be less complete. Open-ended questions are often used

in the exploratory phase to improve understanding of a concept and what


18

language participants use to express it. The disadvantages of open-ended

questions are that they require qualitative methods to code and analyse the

responses which is time consuming and can be subjective (Hulley et al.,

2007). Close-ended questions are far more common, are quicker for the

participants to answer and easier to analyse. The disadvantage of close-

ended questions is that they are not exhaustive, one solution is to include an

option such as “other (please specify)”(Hulley et al., 2007). A useful strategy

is to conduct a pilot study using open questions on a smaller but

representative sample. From these responses the close-ended questions can

be formulated (Machin et al., 2007).

3.5 Testing

If inventories are to be useful, they should also undergo many of the same

reliability and validity checks as other instruments before being implemented.

Figure 1 shows the framework for the development and testing of the PSI.


19

Figure 1 Framework for the development and testing of the PSI

LITERATURE REVIEW

HEALTH PROFESSIONAL

INTERVIEWS

FOCUS GROUPS INTERVIEWS WITH

WOMEN

40- ITEM INVENTORY

FACE VALIDITY TEST RE-TEST

41 – ITEM REFINED INVENTORY

ACCEPTABILITY TO MIDWIVES

USEFULNESS IN PRACTICE

DE

VE

LO

PM

EN

T

INIT

IAL

VA

LID

AT

ION

U

SF

ULN

ES

S


20

4 METHODS

4.1 Design

A mixed methods design was used. It involved inventory development and

testing using interviews, survey and focus group methods. Mixed methods

research is a research design that focuses on collecting, analysing and

mixing, both quantitative and qualitative data in a single study. Its central

premise is that the use of quantitative and qualitative approaches in

combination provides a better understanding of research problems than

either approach alone (Creswell & Plano Clark, 2007).

4.2 Aims

The aim of the project was to develop and validate a Pregnancy Symptoms

Inventory for use by pregnant women and healthcare professionals HCPs

providing their care.

4.3 Participants and setting

The study was conducted at the Royal Brisbane and Women’s Hospital

(RBWH) Maternity Outpatients department, which cares for approximately

5000 pregnant women per year. Participants were medical and midwifery

staff who assisted in the development of the inventory and pregnant women

who were involved in its refinement and testing.

4.4 Procedure

The study was conducted in several phases; these will be described

individually.


21

4.4.1 Phase 1 (Expert consultation)

A group of health professionals working in the RBWH Maternity Outpatients

were interviewed and asked to name all the commonly occurring symptoms

of pregnancy that have been reported to them by the patients they had seen

over the years. The experts consisted of one obstetrician gynaecologist, one

obstetric physician and three experienced midwives. The interviews were

conducted in a semi structured format where the researcher was able to ask

for clarification if the expert described a symptom not encountered before.

The symptoms described by each person were kept in a log; to be reviewed

and categorized after all the experts had been interviewed. A list of

symptoms was then generated.

4.4.2 Phase 2 (Focus groups)

Pregnant women who were able to provide written informed consent and who

had booked in to the Maternity Outpatients department for their obstetric care

were included. Those with major medical problems eg diabetes, renal

impairment, severe psychiatric disturbances, substance abuse, mental

incapacity were excluded. Eligible women were sent a letter and invited to

participate in a focus group where their pregnancy symptoms would be

discussed (see Appendix 3). Focus groups were organised to coincide with

busy clinic days and women of the same trimester were invited to attend a

focus group prior to their routine clinic visit. It was hoped that by combining

the two in one trip to the hospital we would get a better attendance. This type

of recruitment is called opportunistic or convenience sampling. That is, the

researcher used opportunities when she was available, to ask people to


22

participate in the study who she thought may be able to provide useful

information (Holloway & Wheeler, 2002).

The groups were attended by women only (no male partners) to allow for free

discussion of symptoms experienced, as some symptoms were of a sensitive

nature. Whilst it was a preference that toddlers not attend, as we were

recording the focus groups and background noise makes it difficult to hear

the taped conversation, it was impossible to turn away women who arrived

with children as there was no one else to care for them. It in some ways

made the group feel like a “mothers group” having a chat about common or

unique experiences that the women had had during their pregnancy.

Refreshments were offered to create an informal feeling for the focus groups.

A second person was present to help with recording, note taking and

distracting children.

Focus groups consisted of three groups of 5-6 pregnant participants who had

provided written informed consent (Group 1 first trimester up to 12 weeks

gestation; Group 2 second trimester 12 to 28 weeks gestation Group 3 third

trimester 28 to 40 weeks gestation). The goal of the focus group was stated

at the beginning of each session with an explanation that it was the

individual’s experience of pregnancy and any associated symptoms in which

we were interested. Equal participation by each woman was encouraged by

the researcher asking anyone who had not had a chance to speak if they had

different experiences.

A number of times the women needed to be led back to the purpose of the

focus group as they would stray off the subject or a particular participant

would “take over”. Questions were open-ended to encourage discussion


23

amongst the group. The women were asked about symptoms they had

experienced during their pregnancy and, if required, the researcher sought

further clarification or asked for an example to be given. The conversation

was audio taped and transcribed verbatim for analysis. The women’s

terminology formed a basis for the wording of the items to ensure symptoms

were clearly understood.

4.4.3 Reconciliation of Data

All of the common symptoms from the literature review were identified by the

experts and by the women in the focus groups. Only one additional item vivid

dreams was proposed by the women. Therefore using a mixed methods

approach and combining data from each of these sources provides strong

validity for the content of the inventory.

4.4.4 Phase 3 (Development and testing)

Responses from interviews with professionals and focus groups interviews

were combined to develop the “Pregnancy Symptoms Inventory”. Items were

categorized by body part or system using terminology which is understood by

lay people eg gastrointestinal, aches and pains, sleep etc. See Table 2.

The reliability, validity and usefulness of the inventory were tested in a

number of ways.

4.4.4.1 Face Validity

Face validity investigates whether an instrument is calculating the

appropriate construct and whether the items within an instrument measure

the variables in a specific content area (Dempsey & Dempsey, 1992).

Initially, the entire inventory was reviewed by experts to test the face validity.


24

Two groups of 5-9 midwives were asked to comment and give feedback on

the symptoms listed, language used and the positioning of symptoms on the

inventory. All responses from the midwives were noted so that adjustments

could be made to better clarify the inventory.

It was designed to be easily read and understood and was limited to one 2-

sided page so as not to be onerous to fill out. The format allowed for

pregnant women to add additional symptoms and the midwives to add

comments and record their actions on the second page.

The Inventory was then piloted on a group of ten pregnant women to test

readability and comprehension. A number of changes were made to the

language used to describe the symptoms as it was obvious that certain

symptoms were not understood (for example Chloasma became “Brownish

marks on face”). Despite being asked to just circle terms not understood a

number of the women chose to fill in the questionnaire as well. In addition

two women were not Caucasian and had English as a second language, this

may have contributed to some difficulty with understanding the language.

However it is common to have a multiracial group in MOPD and therefore

useful to test the language used in the PSI on a heterozygous group of

women. See Table 1.


25

Table 1 Comprehension and readability of inventory (n=10)

Gestation Race Terms not understood Filled in questionnaire

1 20 weeks Caucasian Chloasma N

2 28.5 weeks Caucasian Vaginal Varicose Vein Y

3 35 weeks Caucasian Vaginal Varicose Vein only symptom not marked

Y

4 28 weeks Caucasian Vaginal Varicose Vein N

5 30 weeks Caucasian Vaginal Varicose Vein N

6 20 weeks Caucasian Y

7 30 weeks Indian Palpitations Chloasma

partial

8 19 weeks Caucasian N

9 27 weeks Macedonian Vaginal Varicose Vein Palpitations Chloasma

N

10 26 weeks Caucasian N

4.4.4.2 Test re-test

The Inventory was completed by 20 women twice, 2-3 days apart to assess

for test-re-test reliability. This time frame was chosen as pregnancy

symptoms can change within a matter of days and the participants were

being asked to recall symptoms over the previous month. This was achieved

by asking the women who were at a routine antenatal visit to consent to fill in

the initial questionnaire. A second self administered questionnaire, which

was coded so that it could be compared to the inventory completed in clinic,

was given to the woman. She was asked to complete it again two to three

days later and send back in a pre-paid self addressed envelope. A second

group of 20 women was sent the questionnaire to complete at home a couple

of days before a planned visit. They were asked to bring the completed

inventory to their visit. They were then asked to repeat the inventory again as

they waited for their planned visit.


26

This was done to overcome a potential bias that suggests that answers may

vary, depending on the environment in which the survey is administered

(Mokkink et al., 2010).

4.4.4.3 Midwives perception of the usefulness of the inventory

Midwives working in the Maternity Outpatients department were educated

about the use of the Pregnancy Symptoms Inventory at their routine lunch

meetings at which 5 to 8 midwives attended. This was repeated several times

to maximize the number of midwives who were aware of the Pregnancy

Symptoms Inventory. The researcher also approached midwives on a one-

on-one basis as 3 midwives had not been present at the in-service sessions.

The one-on-one approach allowed the midwife to ask questions freely and

helped build up a rapport between the researcher and the midwives. The

midwives were informed that each woman arriving for a follow up visit would

be asked to fill in the PSI and asked to hand it to the midwife seeing them

that day. The midwives were then asked to peruse the PSI to see if any

issues had been flagged by the woman as occurring often or affecting them a

lot. This then allowed the midwife to discuss any problems and refer if

necessary to other HCPs. If the woman was to be referred to a HCP the

midwife was asked to record this on the PSI. The Maternity Outpatient

midwives were asked to use the inventory for a one month period and asked

to place the inventories they had been handed in a collection box at the

midwives counter. After the one month trial had ended the midwives were

asked to rate usefulness of the inventory (which was anonymous) on a10cm

visual analogue scale by placing a vertical line through the horizontal line

indicating how useful they found it to be. At one end it said “Not useful at all”


27

the other said “Very useful”. As well as rating the usefulness quantitatively,

midwives were also asked if using the instrument had prompted them to take

any action or if a referral had been organised. They were also asked to

comment on any other aspect of the inventory using an open-ended format.

See Appendix 4.

4.4.4.4 Practical use (Administration of the Inventory)

For this part of the testing phase, women attending the maternity outpatient

clinic were asked to think about symptoms that had occurred in the previous

month and rate them on a 4-point Likert scale according to the frequency of

symptoms “never”, “rarely”, “sometimes”, “often”. A 3-point Likert scale

following this question then asked them to rate how the symptom affected

their activities of daily living as “not limited at all”, “limited a little” or “limited a

lot”. See Appendix 5. The number of categories used in a rating scale has

been subject to debate. While the original Likert scale used 5 categories,

others have argued that more or less may be used, depending on the degree

of accuracy required or what the scales are going to be used for. These are

generally known as Likert-type scales. The choice of 4-item and 3-item

scales used in this study was based on these criteria (Kline, 2005). The

women were also asked to fill in their height, weight and number of weeks

pregnant at the top of the inventory. The inventory was distributed when

women first presented at the clinic. As there is usually a 10-15 minute wait

between arrival at the clinic and the actual midwife visit, they were asked to

complete the inventory, which took 5-7 minutes. This then enabled the

midwife to quickly peruse the inventory and see if there were any areas of

major concern to the woman. The midwife was able to discuss concerns and


28

make a comment in the “Midwife action”, “Referral” (please specify) or

“comment sections” as to what actions, if any, she had taken.

Initially administrative staff were asked to hand the inventory to women as

they arrived, so that the inventory could be filled in while they waited to see

the midwife. It was noted in the first week of the trial not all patients realised it

was to be given to their midwife and nine were handed back to the desk.

Subsequently, administrative staff were educated on the importance of the

inventory being handed to the midwives and this dramatically improved the

number of inventories that were placed in the midwives collection box.

4.5 Ethical Considerations

Approval was granted by the Royal Brisbane and Womens Hospital Ethics

committee and the Queensland University of Technology. The approval

letter is dated 30th Nov 2006 and was assigned the study number 2006/125

(Appendix 6). The Patient Information and Consent Form and patient

invitation letters were approved at that time (Appendix 7). In addition, medical

and nursing directors of Maternal and Newborn Services were approached

for their approval to conduct the study in their departments; the Nurse Unit

Manager also gave her support for the project.

Patients were approached on a individual basis by the researcher and asked

if they would be happy to participate in either a focus group, readability

testing or the test re-test reliability testing. A different group of women were

approached once the pregnancy symptom inventory was ready to be tested

in Maternity Outpatients, these were women booked in to midwife run clinics

for their antenatal care. They were advised that their confidentiality would be


29

maintained, that they were free to withdraw at any time and and that they

would not be reimbursed for their participation. They were given a Patient

Information and Consent Form outlining the study and asked to sign in the

investigator’s presence . This Information contained a statement on how to

contact the Ethics secretary if they wished to speak to someone outside of

the study. All data was stored in compliance with the Ethical standards

required by these Ethics committees.

Specifically, the patient information sheet outlined the following: title and

reason for the research; details of the researcher and supervisor; aim and

purpose of the study; types and methods of data collection; their ability to

withdraw at any time and that their data would be treated in a confidential

manner. They were also provided with contact numbers for answers to any

questions. The patient consent form followed the ethical standards and was

signed prior to interviewing, focus groups and surveying. Participants were

asked if they had read the information sheet and if they had any questions.

They were advised that they could withdraw at any time without ramifications

to their treatment and that study results may be published but in a de-

identified form (Appendix 7). The ethics committee approved the project

which outlined in detail how healthcare professionals (HCPs) working at the

RBWH MOPD would be asked for their opinion and involvement in this study

and did not require separate consent from midwives working in MOPD.


30

5 ANALYSIS

Due to the use of mixed methods in this study, strategies used for data

analysis are reported by phase. All quantitative data was analysed using the

statistical package SPSS version 16.

5.1 Development of inventory:

5.1.1 Phase 1: Expert consultation

Responses from doctors and midwives were collated and a list of symptoms

developed.

5.1.2 Phase 2: Focus groups

Conversations from the focus groups were tape recorded and transcribed.

These were carefully read to detect reference to any symptoms or problems.

When no new symptoms were being identified from discussions with the

women, a list was compiled and the symptoms classified; according to

system headings (for example ‘gastrointestinal’; ‘skin/ hair’). The additional

signs and symptoms identified through the focus group sessions were added

to the Inventory of initial items generated from the expert interviews. This

preliminary inventory was then shown to the midwives for their comment and

feedback.

5.1.3 Phase 3: Validating and testing the Inventory

5.1.3.1 Face validity

Comments from midwives and women about the wording and structure of the

inventory were analysed by scrutinising written comments.


31

5.1.3.2 Test re-test

Test re-test reliability for both the frequency and severity of each sign and

symptom were assessed using the Pearson's 'r' statistic. Correlation values

range from 0 to 1;values of 0.7 and over are considered to indicate

‘substantial agreement’ and values of 0.5 to 0.7 are considered to indicate

‘moderate agreement’ (Schene et al., 2000). Success of the different order of

administering the test re-test was evaluated by the proportion of complete

pairs of responses completed. Only those who returned both completed tests

were able to be evaluated.

5.1.3.3 Usefulness of the inventory

Because midwives responses to usefulness of the inventory on the 10cm

visual analogue scale were not normally distributed results were analysed

using the median and range. The VAS is converted to a score by measuring

the point at which the midwife put a vertical line through the 10cm horizontal

line and measured with a ruler in centimetres. Comments on the usefulness

of the inventory were reported verbatim. Referrals to other HCPs were

analysed using frequency distributions. See Table 3.

5.1.3.4 Practical use

Frequencies were determined by the number of those women experiencing a

particular symptom in the previous month. Demographic data and incidence

and severity of each of the symptoms were calculated using means with their

standard deviations (SD) for all continuous data (eg age, gestation). The

relationship between the frequency and severity of each condition on the

woman’s activities of daily living was assessed by the number of referrals

ordered or offered. When analysing this data frequencies were calculated on


32

completed answers only, missing responses were not used in this

calculation.


33

6 RESULTS

6.1 Phase 1 (Expert healthcare professionals consultation)

During this phase 40 items were produced. The items mentioned most

frequently were nausea, tiredness and sore breasts. Items generated by

experts are prefixed by the letter ‘e’ in Table 2 and have been categorized by

body part or systems as follows. Healthcare professional’s (HCPs) identified

twice as many signs and symptoms as did women in focus groups (40 verus

20). They also nominated all of the symptoms mentioned by the women,

except vivid dreams.

Table 2 Symptoms identified by healthcare professionals (e) and women (f)

Skin/Hair GI Mind Changes Greasy skin-acne e f Nausea e f Short term

memory↓ e f

Varicose Veins e Reflux e f Depression e

Pigmentation-chloasma

e f Constipation e Emotional Highs e f

Itch e Haemorrhoids e Vivid Dreams f

Change in nipples e Vomiting e f Altered body image e

Stretch Marks

e Dry Mouth e

Aches and Pains Genitourinary Sleep

Carpel Tunnel (numb hands)

e Urinary frequency e f Restless Legs e

Aches e ↑Vaginal Discharge e f Poor Sleep e f

Back pain e f Incontinence e f Snoring e

Sciatica e f Thrush e

Breast pain (mastalgia)

e f ↑↓Libido e f

Supra Pubic Ligament Pain

e CVS General

Sacro Iliac Joint Pain

e Dizziness e f Tiredness e f

Headache e f Palpitations e

Leg Cramps e Dyspnoea e

Sore Nipples e Taste/Smell changes

e f


34

6.2 Phase 2 (Focus Groups)

There were twenty symptoms mentioned in the focus groups, nineteen of

which had also been mentioned by the experts; these are prefixed with both

‘e’ and ‘f’ in Table 2.The additional item identified in the focus group sessions

was vivid dreams and is prefixed by the letter ‘f’ in Table 2.

6.3 Phase 3 Validating and testing the inventory

6.3.1 Face validity (midwives)

Originally these symptoms were categorized by body part or system. Some

re-aligning of the position of some symptoms was suggested by the

midwives. Other valuable feedback was provided such as grouping ‘restless

legs’ and ‘leg cramps’ close to each other so that the women understood

these to be different symptoms. A number of symptoms were refined after

discussion with midwives eg supra pubic ligament pain and sacroiliac joint

pain became Hip or Pelvic pain. It was suggested Depression and Anxiety

should be listed separately. Fainting was added under dizziness. Food

cravings were added to the list as a separate item to taste/smell changes.

These changes were shown to the midwives who agreed on the face validity

of the new document.

One other useful comment was to highlight “Please turn over” in bold on the

bottom of the first page so that women did not forget to answer the second

page.


35

6.3.2 Face validity (Comprehension and readability of the

inventory by pregnant women)

The inventory was tested for comprehension and readability by a

convenience sample of 10 women attending their routine clinic visit. The

women were from mixed ethnicity and backgrounds. They were asked to

read the inventory and circle any word they did not understand. Three terms

were not understood eg Chloasma, Palpitations and Vaginal Varicose Vein.

These words were changed to “Brownish marks on face”, “Heart Palpitations”

and “Painful Veins in Vagina”.

Contrary to instructions, a number of the women filled in the inventory despite

being told to just circle the words they did not understand. A number of other

symptoms and comments were also added. Two women did not have English

as their first language however this does reflect the population seen in our

Maternity Outpatients. Details of responses are shown in Table 2.

6.3.3 Test re-test

Individual item test-re-test reliability was between 0.51-1 with the majority (34

items) scoring ≥ 0.70 indicating substantial agreement. See Table 3.

More women in the group who were sent the inventory at home first and then

asked to fill it in again in Maternity Outpatients completed both inventories.

Of the 20 women (gestation range 19 to 39.5 weeks), who were given their

first inventory in the clinic, only nine (45%) returned the second inventory in a

complete enough fashion to be used. By contrast, 14 (70%) of the 20 women

(gestation range 16.5 to 37 weeks), who had a clinic visit booked and who

were contacted by phone and asked if they would be happy to fill in the


36

inventory, remembered to bring in their inventory back and completed the

second inventory in clinic.

Two items did not have sufficient responses to calculate the correlations

(fainting and painful veins in the vagina). However, 23 of the remaining 39

items scored ≥ .80. Items such as nausea, reflux, constipation, dry mouth,

restless legs, thrush, carpel tunnel, shortness of breath, anxiety, vivid

dreams, varicose veins and change in nipples scored ≥.090. Details of all

responses are shown in Table 3.

Table 3 Test re-test results for 23 women in Maternity Outpatients

Symptom R Symptom R

Nausea 1.0 Haemorrhoids .80

Constipation 1.0 Altered Body Image .80 Thrush .98 Breast Pain .79 Restless Legs .97 Dizziness .78 Dry Mouth .96 Heart Palpitations .77 Carpel Tunnel .94 Chloasma .77 Reflux .92 Itch .77 Anxiety .92 Forgetfulness .76 Change in Nipples .92 Poor Sleep .75 Vivid Dreams .91 Back Pain .71 SOB .90 Sciatica .70 Varicose Veins .90 Hip Pelvic Pain .70 Leg Cramps .89 Sore Nipples .70 Headache .88 Urinary Frequency .67 Food Cravings .87 Greasy skin .61 Vomiting .84 Stretch Marks .56 Snoring .84 Taste smell changes .55 Incontinence .84 Tiredness .51

Increased Vaginal Discharge

.84 Painful veins in Vagina *

Change in Libido .84 Fainting * Feeling Depressed .83

* Response not received


37

6.3.4 Usefulness of the inventory

Ten midwives of thirteen who were rostered to work in MOPD were surveyed

on the usefulness of the Pregnancy Symptoms Inventory after they used it for

one month in MOPD in March 2008 using a visual analogue scale (a 10cm

line). Of the three who did not complete the survey two were midwives “filling

in” from birth suite and felt they had not used the inventory for long enough to

comment and one midwife no longer worked for the hospital. The majority of

midwives (7 out of 10) rated the usefulness at >7 and 4 of these midwives

rated it 10 out of 10. The median VAS score was 8.4 (range .9 to 10). Nine

out of ten also said the pregnancy symptom inventory had prompted a

referral for a specific need. Comments indicated that the tool was generally

well accepted and that it had the potential for improving practice. For

example, one respondent said: “Since the survey I have changed the way in

which I conduct a first booking in, to be more mindful of the symptoms of

pregnancy (especially incontinence). Good thing to always update”. Another

said: “This inventory was great at identifying pregnancy related issues that

are in need of referral”. When educating midwives in MOPD on the use of the

PSI it was noted that the more experienced midwives appeared to embrace

the use of the PSI more willingly than the less experienced midwives. Full

details of scores and comments are shown in Table 4.


38

Table 4 Visual Analogue Scale and if PSI prompted referral and

associated comments (Midwife Survey)

Midwife VAS Referral Comment

1 10.0 Yes

2 .9 Yes Physio

3 10.0 Yes Very useful. Referrals made or identified by doing this survey

4 10.0 Yes Keep doing it would love to have it continue

5 2.6 No

6 7.1 Yes

7 8.2 Yes While I found it helpful many midwives seemed to not fully understand how it worked - so needed a easier training explanation

8 8.6 Yes Since the survey I have changed the way in which I conduct a first booking into be more mindful of the symptoms of pregnancy (especially incontinence). Good thing to always update.

9 6.8 Yes Possible opportunity for women to prioritise their concerns. Otherwise very effective tool for identification of symptoms although quite timely.

10 10.0 Yes This survey was great at identifying pregnancy related issues that are in need of referral however more time should be allowed at booking in visit to complete as they are time consuming when you only have an hour to complete the booking in visit

6.3.5 Practical use

6.3.5.1 Characteristics of Respondents

The inventory was given to 211 women attending a routine midwifery

appointment at the MOPD for routine antenatal care between 3rd March 2008

and 7th April 2008. Responses were received for all 211 women only a couple

of women approached did not want to fill in the inventory. Of the 159 women

who gave their age, the mean was 28.9 years (SD 6.16; range 15 – 44

years). The mean gestation was 23.06 weeks (SD 7.46; range 12-42 weeks).

None of the women surveyed were in the first trimester of their pregnancy.

The majority (153) were in their middle trimester (≥12-28 weeks) and 52 were


39

in their third trimester (≥28-42 weeks). The reason that there were no women

in their first trimester was because women do not present to Maternity

Outpatients for their first visit until 18 to 20 weeks unless they have a specific

medical need and are then seen by specialist doctors not midwives for these

visits. The mean Body Mass Index (BMI) for respondents was 26.8 (SD

5.89). This was based on the 174 (82.5%) women who nominated their

height and weight; the remaining 37 (17.5%) women did not know or wish to

disclose either their height or their weight as these questions were left blank.

See Table 5.

Table 5 Demographics of surveyed women (n=211 unless otherwise

stated)

Characteristic Range N (%) or Mean [SD]

Mean Age in Years 15-44 years 28.9 [6.157]

Mean Gestation in weeks 12-42 weeks 23.1 [7.5]

No. of Women < 12 weeks 0

No. of Women ≥12-28 weeks

153/205 (74.6%)

No. of Women ≥28-42 weeks

52/205 (25.4%)

BMI 15.8-50.7 26.76 [5.9]

6.3.5.2 Frequency of symptoms

The frequency of symptoms is shown in descending order in Table 6. The top

four “often” reported symptoms were urinary frequency 109 (52.2%),

tiredness 94 (45.5%), poor sleep 58 (27.5%) and back pain 41 (19.5%).

These were similar to the top four symptoms that women described as “Limit

a Lot” their daily activities (ADLs); these were back pain 19 (11%), tiredness

16 (9.2%), poor sleep 15 (8.5%) and nausea 13 (7%). The total number

responding to questions on “Limit” is less as only those who had experienced


40

that symptom were required to give an answer. Table 7 contains full details.

Whilst some of the symptoms had occurred ‘often’ a number of symptoms

reported less frequently had the potential to adversely affect the women’s

activities of daily living (ADLs). For example, incontinence was reported to

occur “often” by only eight (3.8%) women, however, 34 (16.2%) reported it

occurred sometimes or often and 16 (8.2%) said that this affected their ADLs.

Feeling depressed “often” was only reported to occur in 3 (1.5%) of our

sample however 28 (16%) women said it affected their ADLs. Poor sleep was

reported by 58 (27.5%) women as occurring often however 96 (54.5%)

women said that poor sleep affected their ADLs.

There were eleven “other symptoms” listed on the survey these were swelling

feet and hands (3),hair falling out (2), cramps (2), sore heels(1), body

stiffness (1), heavy stomach (1), sweating (1), pain under ribs (1), watery

eyes (1), cough (1), stuffy nose (1).The symptom which was least described

was fainting with only 2.5% of those who answered the question saying they

had experienced fainting “sometimes”. No one complained of fainting “often”.


41

Table 6 Prevalence of self reported often or sometimes experienced

pregnancy symptoms as a proportion of valid responses.

Frequency N= Valid Responses

Often Sometimes Total Prevalence

Urinary Frequency 209 52.2% 33% 85.2%

Tiredness 209 45.5% 41.5% 87%

Poor Sleep 211 27.5% 35.05% 62.55%

Back Pain 210 19.5% 40.5% 60.0%

Vaginal Discharge 205 17.6% 32.2% 49.8%

Forgetfulness 198 15.7% 39.9% 55.6%

Headache 200 14.5% 36% 50.5%

Vivid Dreams 201 13.9% 27.4% 41.3%

Taste Smell Changes 197 13.7% 20.3% 34.0%

Change in Nipples 196 13.3% 25% 38.8%

Nausea 207 12.6% 21.7% 34.3%

Change in Libido 197 11.2% 32% 43.2%

Hip Pelvic Pain 199 10.6% 23.1% 33.7%

Constipation 207 10.1% 23.1% 33.2%

Food Cravings 208 9.1% 28.4% 37.5%

Reflux 203 8.9% 20.7% 29.6%

Leg Cramps 210 8.6% 22.9% 31.5%

Dizziness 200 8.5% 19% 27.5%

Stretch Marks 193 7.8% 10.9% 18.7%

Greasy Skin Acne 199 7.5% 18.6% 26.1%

Restless Legs 208 7.2% 23.1% 30.3%

Dry Mouth 210 7.1% 25.7% 32.8%

Breast Pain 173 6.5% 25.5% 32.0%

Altered Body Image 190 6.3% 19.5% 25.8%

Vomiting 210 6.2% 11.4% 17.6%

Sore Nipples 199 6.0% 23.6% 29.6%

Shortness of Breath 201 5.0% 25.9% 30.9%

Itch 198 4.5% 17.7% 22.2%

Snoring 207 4.3% 10.6% 14.9%

Varicose Veins 194 4.1% 12.9% 17.0%

Incontinence 209 3.8% 12.4% 16.2%

Carpel Tunnel 208 3.4% 7.7% 11.1%

Sciatica 209 3.3% 14.4% 17.7%

Anxiety 200 3.0% 16.5% 19.5%

Chloasma 201 3.0% 3.0% 6.0%

Thrush 203 2.5% 6.4% 8.9%

Painful Vein in Vagina 204 2.5% 2.9% 5.4%

Haemorrhoids 203 1.5% 4.4% 5.9%

Feeling Depressed 201 1.5% 20.4% 21.9%

Heart Palpitations 197 1.0% 9.1% 10.1%

Fainting 198 0.0% 2.5% 2.5%

As the number of women responding to questions varied, the denominator is displayed for each symptom (N)


42

Table 7 Prevalence of self-reported limitation as a proportion of those

women who reported experiencing the symptom.

Frequency N Limit a lot Limit a little

Total Prevalence

Back pain 173 11.0% 41% 52.0% Tiredness 173 9.2% 67.3% 76.3%

Poor Sleep 176 8.5% 46% 54.5% Nausea 186 7% 23.1% 30.1%

Headache 167 6.6% 44.3% 50.9% Hip Pelvic Pain 199 6.3% 22.2% 28.5%

Vomiting 194 5.2% 13.9% 19.1% Forgetfulness 168 4.8% 29.8% 34.6%

Sciatica 195 4.1% 9.3% 13.4% Urinary Frequency 173 2.9% 36.4% 39.3%

Change in Libido 175 2.9% 14.9% 17.8% Altered body image 172 2.3% 8.1% 10.4%

SOB 177 2.3% 23.2% 25.5% Dizziness 177 1.7% 26.2% 28.3%

Stretch Marks 174 1.7% 2.3% 4.0% Food Cravings 183 1.6% 3.3% 4.9%

Leg Cramps 183 1.6% 15.3% 16.9% Restless Legs 184 1.6% 12% 13.6%

Incontinence 194 1.5% 6.7% 8.2% Change in Nipples 171 1.2% 4.7% 5.9%

Constipation 185 1.1% 10.3% 11.4% Reflux 186 1.1% 14% 15.1%

Thrush 194 1.0% 3.1% 4.1% Painful vein in Vag 200 1.0% 2.5% 3.5% Vaginal Discharge 173 0.6% 6.9% 7.5%

Taste Smell changes 178 0.6% 15.2% 15.8% Breast Pain 174 0.6% 8.0% 8.6%

Anxiety 200 0.6% 12.2% 12.8% Feeling Depressed 175 0.6% 15.4% 16.0%

Greasy skin acne 182 0.5% 4.9% 5.4% Dry Mouth 189 0.5% 2.6% 3.1%

Itch 183 0.5% 4.4% 4.9% Snoring 188 0.5% 1.6% 2.1%

Varicose veins 183 0.5% 4.4% 4.9% Carpel tunnel 204 0.5% 4.4% 4.9% Vivid dreams 175 0.0% 4.6% 4.6% Sore Nipples 174 0.0% 8.2% 8.2%

Chloasma 190 0.0% 0.5% 0.5% Haemorrhoids 199 0.0% 1.0% 1.0%

Heart Palpitations 190 0.0% 6.3% 6.3% Fainting 190 0.0% 2.1% 2.1%

As the number of women responding to questions varied, the denominator is displayed for each symptom (N). Women who did not experience a symptom did not answer limit question.


43

6.3.5.3 Relationships between symptoms and referrals

Because a number of symptoms seemed to be linked a post-hoc analysis

was conducted. Statistically significant relationships can be seen in Table 8.

Poor sleep had a strong association with a number of symptoms including

back pain (0.001), restless legs (0.013), feeling depressed (0.002), anxiety

(0.043), tiredness (0.008) and urinary frequency (0.018). Tiredness and

Nausea were also related (0.028).

Table 8 Statistically significant relationships between symptoms and

referrals from the inventory (n=211)

Symptom P* N of valid cases

Tiredness and Nausea 0.028 206 Poor Sleep and Back pain 0.001 210 Poor Sleep and Restless Legs 0.013 208 Poor Sleep and Feeling Depressed 0.002 201 Poor Sleep and Anxiety 0.043 200 Poor Sleep and Tiredness 0.008 209 Poor Sleep and Urinary Frequency 0.018 209 Feeling Depressed and Mental Health Nurse 0.008 201 Anxiety and Mental Health Nurse 0.004 200 Back Pain and Physio Referral 0.002 210 Hip/ Pelvic Pain and Physio Referral 0.009 199

*Pearsons Chi-Square

Referrals

In the one month trial midwives made or suggested a number of referrals

[see Table 9]. Of the 211 inventories 25 (11.9%) women were referred to a

physiotherapist with an additional 10 (4.7%) declining the physiotherapy

referral; 11 (5.2%) women were referred to the continence nurse with an

additional two (1.0%) declining this referral; and five (2.4%) were referred to

the mental health nurse; six (2.8%) more women, who were assessed as


44

needing mental health support declined the referral. Relationships between

symptoms and referrals included: physiotherapy referral and back pain

(0.002); physiotherapy referral and hip/pelvic pain (0.009); mental health

nurse referral and feeling depressed (0.008) and mental health nurse referral

and anxiety (0.004).

Table 9 Proportion of referrals by midwives documented on

Pregnancy Symptom Inventory (n = 211)

Referrals N (%)

Physiotherapy Referrals 25 (11.8%) Continence Nurse Referral 11 (5.2%) Blood Tests 6 (2.8%) Mental Health Nurse Referral 5 (2.3%) Dietitian Referral 2 (0.9%) Urine Tests 2 (0.9%) Social work Referral 1 (0.4%) General Practitioner Referral 1 (0.4%) Declined Physiotherapy

10 (4.7%)

Declined Mental Health Nurse 6 (2.8%) Declined Continence Nurse Referral 2 (0.9%) Declined Social Work Referral 1 (0.4%)

Other referrals made by the midwives included referral for blood tests (ie

haemoglobin for women complaining of tiredness or shortness of breath) and

midstream urine tests ordered for women with frequency of urine.

The continence nurse keeps accurate records of all referrals she receives

from the MOPD. Consequently, she was able to provide a snap shot of

referrals made during the 12-month period in which the trial was conducted.

The trial of the inventory ran from March 3rd 2008 to 9th April 2008 in the

MOPD. As can be seen in Figure 2, there was a dramatic rise in the number


45

of referrals to the continence nurse in the month of March 2008 (from an

average of 1.8/month for the year up to 17 referrals in March) when the

pregnancy symptoms inventory was being trialled. This represents more than

an eight-fold increase in the number of referrals. The effect of the inventory

on referrals is further demonstrated by a return to normal referral patterns

once the trial finished. The discrepancy between the number of referrals (11)

made by midwives who used the inventory and the continence nurse (17)

could be that the midwife forgot to note their referral on the inventory or other

physician-based referrals were made to this service from MOPD.

Referrals to the physiotherapist and the mental health nurse can be seen in

Table 9. It was not possible to gain accurate referral numbers for the

previous 12 months from these departments.

Figure 2 Incontinence referrals from Maternity Outpatients

024

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7

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46

7 DISCUSSION

7.1 Questionnaire Development

The development of the Pregnancy Symptoms Inventory followed a rigorous

multi- step approach involving a literature review, expert interviews, focus

groups, face validity testing, comprehension and readability assessment,

test-re-test analyses and content analysis to produce a multi-item scale

which was piloted by midwives who then assessed its usefulness on a Visual

Analogue Scale. The available literature on health scale development

supports the use of these methods when designing such a tool. (Bowling &

Ebrahim, 2005; Cheraghi et al., 2009; Hulley et al., 2007; Victorson et al.,

2008). This study focused on the development of a tool that

comprehensively assessed multiple symptom categories on a scale reflecting

important clinical criteria. It was designed to be on a 2-sided page so that it

could be easily read and understood and not too onerous to fill out. It also

allowed for pregnant women to add additional symptoms and the midwives to

add comments and record their actions on the second page. Keeping it to

one page would allow it to be added to the women’s medical notes more

easily for future reference.

The aim of this study was to design and validate a Pregnancy Symptoms

Inventory. The extent to which this aim has been achieved will be discussed

using a framework of the specific research questions asked and the

hypotheses proposed. For convenience and because they are associated,

question one and question two will be combined.


47

Question 1: What pregnancy signs and symptoms are reported by

healthcare professionals? And

Question 2: What pregnancy signs and symptoms are reported by

patients?

The Pregnancy Symptoms Inventory (PSI) is a new, comprehensive

instrument for use in antenatal care. It was developed using semi structured

interviews with expert healthcare workers, working in an obstetric

environment and focus groups of pregnant women. Healthcare professionals

identified twice as many signs and symptoms as did women in focus groups

(40 verus 20). They also nominated all of the symptoms mentioned by the

women, except vivid dreams. This may be because HCPs see so many

women in their work life and are very familiar with problems reported to them.

Whereas the women in the focus groups had only their own experiences from

which to draw. Healthcare professional’s (HCPs) were also more likely to

mention physical problems such as dyspnoea, sacro-iliac joint pain, nipple

changes, stretch marks and varicose veins than the women. However, this

may be an artefact of the numbers in the focus groups which totalled 5-6

women. These numbers may not have allowed for the full diversity of

symptoms experienced during pregnancy. Irrespective of this, it was

pleasing to see that healthcare professional’s (HCPs) did nominate all of the

issues that were also a concern to women. However, it does not follow that

they necessarily enquire about these problems at an antenatal visit, so the

self-completed inventory should prove useful for women when engaging in

dialogue with their HCP. The dramatic increase in incontinence referrals for


48

the month the PSI was used certainly supports the notion that it helps to

engage women and their HCP in dialogue about issues which are troubling.

The most often reported symptoms in the inventory of 211 women were,

urinary frequency (52.2%) tiredness (45.5%) poor sleep (27.5%) and back

pain(19.5%) this is in agreement with the findings in Zib et al’s 1999 study

which stated all 4 of these symptoms in their top 5 most frequently reported

symptoms. Nausea was described by 34.3% of the surveyed women who

were in their 2nd or 3rd trimester and 30.1% said it had affected their daily

activities. As it is commonly expected that many women suffer nausea in

their first trimester and that many describe it as disappearing in their 2nd

trimester this is a significant number of women who had nausea beyond the

first trimester. Lacasse et al 2009 described 40.1% of her 367 patients

suffered nausea and vomiting of pregnancy into their second trimester. Davis

2004 found in her evidence based review that only 50% of pregnant women

had relief by 14 weeks(Davis, 2004).

Tiredness or fatigue was reported in this study “sometimes or often” in 87%

of the women. This is almost identical to the study of 476 Scandinavian

women which showed that over 90% of their sample experienced fatigue

throughout their pregnancy (Rodriguez et al., 2001). This, almost universal

state, may be due to the physical affect of pregnancy per se or the heavy

workload demands on women in general, who are frequently in full-time

employment as well as managing households.

Back pain affected 60% of our sample, ‘sometimes or often’ and this concurs

with a number of studies that report rates of between 55-75% (Kristiansson et


49

al., 1996; Mogren & Pohjanen, 2005; Orvieto et al, 1994; Pool-Goudzwaard,

2005). Although such a high proportion of women reported back pain, very

few are referred to a physiotherapist for management. For example, when we

reviewed referral patterns only 17% had been offered physiotherapy referral.

This highlights the need for greater attention to be paid to symptoms during

pregnancy. The Pregnancy Symptoms Inventory should prove useful in

alerting HCP to signs and symptoms they may otherwise be unaware. The

inventory when added to the patient record may also result in a reduction in

the frequency of repetitive questions about their symptoms.

In summary, seeking advice from experts and pregnant women gave a well

rounded picture of the many and varied symptoms experienced in pregnancy.

It was reassuring to have a large number of the symptoms reported from both

sources. Whilst this Pregnancy Symptoms Inventory is not exhaustive it is

detailed and allows for “other symptoms” to be listed by the woman giving her

an opportunity to bring up any other symptom that has been bothersome.

The generation of an inventory of symptoms known to occur in pregnancy

may help as many women do not associate a range of symptoms with being

pregnant and are unaware that pregnancy can cause or exacerbate

symptoms. Anecdotal evidence from pregnant women indicates that there is

a culture of putting up with discomforts which in some cases can be

alleviated by appropriate care and treatment for example tiredness and

shortness of breath can both be symptoms of a low haemoglobin and easily

treated with iron supplements. Frequency of urine can indicate a urinary tract

infection which are common in pregnancy and easily identified if a microurine

sample is taken and sent to pathology. Back pain can benefit from


50

physiotherapy for strengthening exercises and incontinence problems

alleviated by referral to the incontinence nurse or physiotherapist for pelvic

floor exercises.

Question 3: Can these signs and symptoms be combined in a

pregnancy symptoms inventory that would be useful to health workers

who provide care to pregnant women?

Initial testing of the PSI in the current study is encouraging. Some questions

had a lower response rate and it may be useful to investigate reasons for

this. However, the lowest response rate was 82%, which remains acceptable.

Face validity testing produced some changes that were easily incorporated

after being reviewed by a random group of pregnant women from different

ethnic backgrounds and experienced midwives. Dempsey and Dempsey

(1992) stated that face validity investigates whether an instrument is

calculating the appropriate construct and whether the items within an

instrument measure the variables in a specific content area. The test re-test

results showed the majority of symptoms 87% scored ≥.70 and 59% scored

≥.80%. It was also well accepted by staff and patients with many positive

comments made by experienced midwives. Forty percent of the midwives

surveyed scored the inventory at the highest possible score 10 out of 10.

Seventy percent of the midwives scored the usefulness at 7 out of 10 or

higher. Of the three midwives who scored the usefulness at less than seven

out of 10 one referred to a physiotherapist as a result of using the tool and

the other commented that it was a “very effective tool for identification of

symptoms “ but made a comment on how long it took .


51

Question 4. Does the use of a pregnancy symptoms inventory result in

an increase in referrals to appropriate service providers?

The rate of referrals to our continence nurse, increased by over 8 fold the

month of the trial. This backs up Chiarelli’s 2004 claim that patients and

medical practitioners alike are reticent to discuss this somewhat

embarrassing subject (of incontinence.) This study lead to the MOPD adding

a question on continence to their clinic visits with midwives, as this issue had

clearly been under reported in the past by patients.

During the study period referrals to other healthcare professionals were

made and recorded on the PSI however it is unclear if the referrals were an

increase on usual practice as no baseline data for these referrals was

available. Women who described urinary symptoms were asked for a

microurine to rule out urinary tract infections as a cause. This is well within

the scope of practice for midwives. Other issues such as tiredness, fatigue

and shortness of breath were managed by ordering a full blood count to

check the woman’s haemoglobin levels which can often dip in pregnancy.

This is often treated with iron supplements.

Early detection and treatment of symptoms can often prevent a worsening of

the symptom which can lead to loss of work and quality of life. The American

College of Obstetricians and Gynaecologists 2004 guidelines on nausea and

vomiting of pregnancy state “failure to treat early manifestations of nausea

and vomiting of pregnancy increases the likelihood of hospital admissions for

hyperemesis gravidarum”. It has also been stated that “cultural beliefs and

taboos, lack of knowledge and information, and lack of healthcare providers’


52

knowledge regarding incontinence all contribute to a lack of treatment

seeking” (Bush et al., 2001).

7.2 Hypotheses

The study proposed two hypotheses:

1) That a pregnancy symptoms inventory, when used as part of a

standard prenatal visit, will be useful to healthcare professionals; and

2) That a pregnancy symptoms inventory will identify, and be able to

discriminate between mild conditions and those requiring intervention.

The first hypothesis is supported. It has been clearly shown that the midwives

in the Maternity Outpatients found it to be a useful tool with comments such

as “Referrals made or identified by doing this inventory” and “very effective

tool for identification of symptoms” being made. Other comments which

indicate that the PSI has the ability to implement practice change include

“Since the survey I have changed the way in which I conduct a first

booking in to be more mindful of the symptoms of pregnancy

(especially incontinence). Good thing to always update.”

The second hypothesis was supported to some extent. There was certainly

some evidence that women who reported symptoms, often, were referred to

a healthcare professional. The aim of any new tool would be that referrals are

only made where necessary so as not to waste limited resources. To the

authors’ knowledge, this is the first time such a relationship has been shown

and provides further evidence for the usefulness of the Inventory in both

practice and in research settings.


53

7.3 Midwives Attitudes and Practice Change

One finding which was a surprise to the researcher was that the more

experienced midwives in clinic seemed to be more open and accepting of the

Pregnancy Symptom Inventory as a potentially useful risk assessment tool,

whilst the less experienced midwives were cautious of this new “form”. It is

often felt that older people are more resistant to change (McGregor & Gray,

2002) but conversely the more senior midwives experience may have lead

them to accept something they see as making their job easier.

One of the comments made was that the inventory was seen as “more work”

and that they would need more time to do a “booking in” visit if they were to

go through the inventory with each woman.

It would appear that other researchers (McKellar et al., 2009) discovered

“that the negativity of the ward midwives regarding innovations implemented

in her study contrasted strikingly with the positive responses from both

parents and the action research midwives.” She explained that two themes

emerged which may explain the response of the midwives to the actions;

firstly a lack of ownership of the actions and secondly, the problematic nature

of the current culture of the postnatal-care environment. Whilst this study

refers to the postnatal environment and the current study was done in the

antenatal setting of the busy Maternity Outpatient clinic, similar themes of

time pressure and midwives being rotated in from other areas to perform

tasks is common to both settings. In such busy situations, a researcher

asking for assistance to trial an inventory may appear onerous to some staff.


54

Implementing practice change is always difficult but it is often facilitated by

the presence and support of a clinical champion from the area, one who has

the respect of other staff. Other suggestions when implementing the PSI

would be to conduct inservice sessions outlining which patients to refer to

physiotherapy, the continence nurse, the mental health team or which blood

tests to order for certain symptoms. The impression from the current study

was that in general, staff were trying to do a good job in an often hectic

environment. One of the factors that contributed to the success of the project

was that the investigator had been exposed to the staff in the previous 12-

months whilst working on another project in the Maternity Outpatients clinic;

so was consequently well known and trusted.

7.4 Limitations

There were a number of qualitative aspects to the study, which are potentially

open to biases (Mays & Pope, 1996). Strategies to reduce the researchers

bias /own opinion included the use of a mixed method approach where

information underpinning the development of the inventory was sought from

two different groups (expert interviews and focus groups). Subsequently the

instrument was subjected to validation by experts and other pregnant

women. There were also inservice sessions with the midwives where they

were asked for comment and allowed to express their views regarding the

Pregnancy Symptoms Inventory. Despite the addition of the words “please

turn over “ in bold on the bottom of the first page, a number of women still

only filled in one page of the inventory. This could have occurred due to lack

of time before being called into clinic visit or disinterest.


55

Another limitation was the lack of baseline data around referrals to other

health professionals, and blood and other test ordering patterns. The only

useable baseline data was from the Continence Nurse, so it was not possible

to determine the affect of the inventory on other areas. However, the

midwives did indicate on the PSI, that after reviewing responses they had

offered their patient a referral or ordered a test.

The Pregnancy Symptoms Inventory (PSI) provides information only on

women in their second and third trimesters as none of the 211 women

surveyed with the PSI were in their first trimester. This is because the

majority of women are not “booked in” to MOPD until 18 weeks unless they

have a medical condition or a previous pregnancy outcome which indicates

that they need early follow up. Before their first visit to our clinic, women see

their own general practitioner (GP) for pregnancy confirmation and early

pregnancy care. These GPs were too numerous to make it feasible to access

women in their first trimester.

However, focus groups did include women who were in their first trimester

and the discussions with this group predominantly discussed nausea,

vomiting and tiredness as a major concern early in their pregnancy.

Therefore the incidence of these symptoms may be higher if we had a more

representative group. The symptom swollen hands and feet, common in

pregnancy, were somehow not mentioned in discussions with experts and

focus groups. This problem was noted by a woman on the “other symptoms”

early in the survey of 211 but was not feasible to add as the inventory was

underway. There were eleven “other symptoms” listed on the survey these

were swelling feet and hands (3),hair falling out (2), cramps (2), sore


56

heels(1), body stiffness (1), heavy stomach (1), sweating (1), pain under ribs

(1),watery eyes (1), cough (1), stuffy nose (1).

7.5 Implications for Practice

The Pregnancy Symptoms Inventory may be a useful tool for pregnancy care

providers when used to detect and treat symptoms and could become part of

routine care. The effectiveness of the instrument may be enhanced if the

midwife addressed any unanswered items, as they may not have been

understood. One current outcome of this study has been that the MOPD at

the Royal Brisbane and Women’s Hospital has introduced a pathway for

asking questions on continence based on the huge increase in referrals to

the Continence nurse during the study and this is now a routine part of the

antenatal visit.

Introduction of the Pregnancy Symptom Inventory by a clinical champion

from the clinic in which it is to be used, would aid acceptance of the tool. It

could be accompanied by a clinical pathway or decision tool to provide

guidance about 1) when to refer and to whom; 2) appropriate test to order

and; 3) appropriate advice to provide. In terms of the instrument itself,

swollen hands and feet should be added to the inventory; it is a very common

symptom and, in certain patients an indicator that they could be developing

preeclampsia.

7.6 Implications for Pregnant Women

There are many “old wives tales” surrounding pregnancy, many learnt from

family and friends and not always evidence based which gives women a

distorted view of what is normal in pregnancy. Some symptoms such as


57

incontinence may be embarrassing for women to bring up with their midwife.

So the ability to tick a box on an inventory, which is reviewed by their

midwife, who can then take appropriate action referring them where

necessary, may benefit women. For example 13 women offered a continence

referral 11 women accepted the referral to seek help for their symptoms.

Pregnant women who were involved in the focus groups and those who

completed the inventory were more than happy to share their experiences. In

the focus groups, in particular, women who did not know each other found

the experience of being pregnant at the same time a bonding experience and

were very happy to discuss their individual experiences. They seemed happy

that someone was interested in how they were feeling.

7.7 Recommendations for Research

Further testing of the usefulness of the inventory in larger and other

populations is required. In any such research, baseline data around referral

patterns and the ordering of blood and other tests should be collected. This

would allow the effect of the Inventory on these indicators to be measured.

Any future research should include women in their first trimester. It could be

beneficial to record the parity as it would be interesting to see if this has any

effect on outcomes.

In addition, the PSI could be used as an outcome measure to assess the

impact of lifestyle interventions, in pregnancy, such as increased social

support or exercise programs. The Inventory would be useful in these

circumstances because social issues, support and access to health care are


58

frequently related to many of the symptoms described, such as depression,

nausea/vomiting and pain.

7.8 Conclusions

At this time no brief comprehensive assessment tool exists that examines

pregnancy related symptoms in their entirety. The results of the reliability and

validity of the tool are promising. The Pregnancy Symptoms Inventory was

generally well accepted by midwives and could be a useful tool for pregnancy

care providers, aiding clinicians in early detection and subsequent treatment

of symptoms.


59

Acknowledgements I would like to thank the midwives and administrative staff in the Maternity

Outpatients at the Royal Brisbane and Women’s Hospital for their help in

conducting this study in their department.

Also my supervisors Nuala Byrne and Joan Webster for their invaluable

advice and expertise.

I would not have been able to proceed with this research without the support

of Dr Charles Denaro and Dr Leonie Callaway.


60

Appendix 1 Prevention of Gestational Diabetes

halla

Due to copyright restrictions, this article is not available here. Please consult the hardcopy thesis available from QUT Library or view the published version online at: http://dx.doi.org/10.2337/dc09-2336


64

Appendix 2 Exercise in obese pregnant women:

The role of social factors, lifestyle and pregnancy

symptoms

Exercise in obese pregnant women: The role of social factors, lifestyle and pregnancy symptoms.

Katie F Foxcroft*¹§, Ingrid J Rowlands*2, Nuala M Byrne3, H David McIntyre4, and

5Leonie K Callaway5 For the BAMBINO group†

¹ Department of Internal Medicine, Royal Brisbane and Women’s Hospital, Brisbane, Australia

² Queensland Institute of Medical Research and School of Population Health, University of Queensland, Brisbane, Australia.

3School of Human Movement Studies and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia

4, Head of Mater Clinical School, School of Medicine, University of Queensland

5, Royal Brisbane and Women’s Hospital and School of Medicine, University of Queensland, Brisbane, Australia

* These authors contributed equally to this work

§Corresponding author

† The complete BAMBINO Group: Leonie K.Callaway, Paul B.Colditz, Nuala M.Byrne, Barbara E. Lingwood, Ingrid J. Rowlands, Ainsley Groves, Xanthe Sansome, Briony R. O’Connor, Susan Croaker, Katie Foxcroft, and H.David McIntyre

Email addresses:

KFF: [email protected]

IJR: [email protected]

NMB: [email protected]

HDM: [email protected]

LKC: [email protected]

-1-

mailto:[email protected]




Abstract Background

Physical activity may reduce the risk of adverse maternal outcomes, yet there are very

few studies that have examined the correlates of exercise amongst obese women

during pregnancy. We examined which relevant sociodemographic, obstetric, and

health behaviour variables and pregnancy symptoms were associated with exercise in

a small sample of obese pregnant women.

Methods

This was a secondary analysis using data from an exercise intervention for the

prevention of gestational diabetes in obese pregnant women. Using the Pregnancy

Physical Activity Questionnaire (PPAQ), 50 obese pregnant women were classified as

“Exercisers” if they achieved ≥900 kcal/wk of exercise and “Non-Exercisers” if they

did not meet this criterion. Analyses examined which relevant variables were

associated with exercise status at 12, 20, 28 and 36 weeks gestation.

Results

Obese pregnant women with a history of miscarriage; who had children living at

home; who had a lower pre-pregnancy weight; reported no nausea and vomiting; and

who had no lower back pain, were those women who were most likely to have

exercised in early pregnancy. Exercise in late pregnancy was most common among

tertiary educated women.

Conclusions

Offering greater support to women from disadvantaged backgrounds and closely

monitoring women who report persistent nausea and vomiting or lower back pain in

early pregnancy may be important. The findings may be particularly useful for other

interventions aimed at reducing or controlling weight gain in obese pregnant women.

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Word count: 231

-3-

Background Physical activity during pregnancy is important for women’s general health and may

reduce the risk of adverse maternal, fetal and neonatal outcomes. Current

recommendations advise pregnant women without medical or obstetric complications

to aim for 30 minutes of physical activity on most days of the week [1]. Randomised

controlled trials have shown that the uptake of regular exercise among sedentary

pregnant women has significant benefits for women in pregnancy. Specifically,

women who participated in three hours of weekly vigorous exercise in pregnancy

reported greater satisfaction with their physical stamina, energy levels, appearance

and general health than sedentary pregnant women [2]. In another study of pregnant

women who were overweight, participation in three hours of aerobic exercise per

week was associated with higher fitness levels as demonstrated by increased oxygen

uptake, than overweight women who remained sedentary [3]. Exercise also appears to

have benefits for neonates, with the uptake of moderate-intensity exercise in

pregnancy being associated with normal fetal growth [4]. However, some women may

have difficulty meeting current recommendations, or participating in physical activity

altogether during pregnancy because of health and psychosocial factors.

The correlates of physical activity among women during pregnancy have been

examined in only a few studies. Sociodemographic variables such as education and

income [5-8] have been positively associated with physical activity in pregnancy

whereas a negative association has been found for age [7, 9]. Women who have

children at home and an unfavourable pregnancy history [9] are less likely to be

physically active during pregnancy. Although there is limited evidence, psychosocial

variables such as employment during pregnancy and lack of childcare [10] have also

been identified as correlates of physical activity in pregnancy [11]. However, overall

-4-

the evidence tends to be conflicting with several studies finding no relationship

between these variables and women’s physical activity levels during pregnancy.

Women’s physical health and health behaviours before and during pregnancy may be

important predictors of physical activity during pregnancy. Women who have a high

pre-pregnancy body mass index (BMI) [11] or who smoke [6, 7] are less likely to be

physically active in pregnancy. On the other hand, pre-pregnancy physical activity has

been associated with remaining physically active during pregnancy [10]. Remaining

active during pregnancy may be beneficial for women’s well-being, with one study

showing that exercise during the first trimester of pregnancy was related to reduced

reporting of nausea and vomiting in the 2nd trimester of pregnancy[12].

Physical symptoms are common and normal in pregnancy, but they may deter or

prevent some women from exercising during pregnancy. For example, almost 80% of

pregnant women experience nausea and vomiting [12] in their first trimester.

Although this generally resolves by the 12th week of pregnancy, around 40% of

women report nausea and vomiting into their second trimester and some women are

affected for the entire pregnancy. Further, back pain during pregnancy affects

anywhere between 24 and 90% of women and may interfere with women’s ability to

exercise [13, 14]. While pregnancy symptoms may have a large impact on women’s

wellbeing, there is evidence to suggest that exercise may improve women’s

symptoms[8].The correlates of exercise during pregnancy among women who are

obese have not been examined. Women who are obese are at the greatest risk for

pregnancy complications [15] and weight retention in the longer term [16], and thus it

seems important to examine whether there are factors that are common to obese

pregnant women who do exercise. This study examines the correlates of exercise in a

small sample of pregnant women who were identified as achieving, or not achieving

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adequate exercise-specific energy expenditure requirements throughout their

pregnancy. We expected that the relevant sociodemographic, obstetric and health

behaviour variables, and pregnancy symptoms, would be associated with exercise

during pregnancy in this group of women. This information would be useful for

informing lifestyle interventions that aim to reduce or control weight gain among

obese pregnant women.

Methods Participants

This is a secondary analysis of a study of 50 women who were recruited as part of a

randomised controlled trial (RCT) examining the feasibility of an individualised

exercise program for obese women during pregnancy. Full details of study design and

participant recruitment have been reported previously [17]. Women receiving

antenatal care and delivering at the Royal Brisbane and Women’s Hospital (RBWH)

in Queensland, Australia, were recruited from the hospital’s maternity outpatient

clinic between 12 and 14 weeks gestation. Ethics clearance was obtained for the study

from the Royal Brisbane and Women’s Hospital (RBWH) Human Research Ethics

Committee. The RCT study is registered with the Australian Clinical Trials Registry

(ACTRN012606000271505). Women were included in the study if they were: aged

18-45; had a BMI of 30 kg.m-2 or greater; were willing to participate in an exercise

program; and able to provide informed consent. Exclusion criteria included: non-

English speaking; contraindication or inability to exercise; medical or obstetric

contraindication to exercise including hemodynamically significant heart disease;

restrictive lung disease; incompetent cervix (cerclage); multiple gestation; severe

anemia; chronic bronchitis; type 1 diabetes; orthopaedic limitations; poorly controlled

seizure disorder; poorly controlled hyperthyroidism; heavy smoker.

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Pre-intervention Stage.All eligible women were invited to attend a single early group

education session at around 12 weeks gestation. Women received written information

on exercise[1], nutrition [18] and weight gain during pregnancy[19]. The women were

subsequently invited to attend a face-to-face interview with a research midwife.

Interviews collected information on demographics and physical and mental health and

health behaviours.

Intervention

Women randomized to the intervention received a) an individualised exercise plan b)

regular exercise advice and c) paper-based diaries for self-monitoring. A face-to-face

interview at ≈12 weeks with a physiotherapist, who had expertise in pregnancy

management and exercise physiology, was conducted to develop women’s

individualized exercise plans; to assess readiness for change, and encourage goal

setting. Women were reviewed every 4 weeks by physiotherapists, with phone calls

between visits to assess their adherence to the program. Women who were not

meeting exercise targets had additional face-to-face support, with identification of

barriers and modification of the exercise plan.

Both the intervention and control groups were followed up at 12, 20, 28 and 36 weeks

by a research midwife who recorded their weight, pregnancy symptoms and

administered the PPAQ.

Energy Expenditure

We examined the correlates of energy expenditure, which are expressed as

kilocalories per week (kcal) in this paper. Energy expenditure was derived from the

Pregnancy Physical Activity Questionnaire (PPAQ). Data was collected at 12, 20, 28

and 36 weeks gestation.

-7-

Pregnancy physical activity questionnaire (PPAQ; [20]). This is a self-report

instrument which measures the time spent participating in 32 activities including

household/caregiving, occupational, sports/exercise, transportation, and inactivity.

The PPAQ is reliable and valid measure of exercise during pregnancy. Specifically,

the intraclass correlation coefficient for the sports and exercise activity subscale was

0.83, and scores for the sports and exercise subscale correlate moderately with

actigraph data [20].

From the PPAQ, we extracted data for sports and exercise activities only. The types of

sports and exercise activities assessed in the PPAQ include walking, jogging, prenatal

exercise classes, swimming and dancing. To calculate weekly energy expenditure

using the PPAQ, the duration of time spent in these exercise activities was multiplied

by specific intensities (i.e. MET values) and scores are expressed as MET-hours per

week.

In order take into account the women’s weight, which can greatly affect energy

expenditure, weekly kilocalories (kcals) expended by the women during exercise was

calculated. Weekly kcals at each time point were derived by multiplying MET-hours

per week by weight (kg). Because the data was severely skewed, it was converted into

categorical outcome variables at each time point. Because there are no recommended

cut-offs, we chose the cut-point of 900 kcal/wk based the results of prior exercise

intervention delivered to non-pregnant, obese individuals [21]. Thus, at each time

point, women who achieved < 900 kcal/wk were classified as “Non-exercisers” and

women who achieved > 900 kcal/wk were classified as “Exercisers”.

-8-

Predictor Variables

Background information. A semi-structured interview was used to collect information

on maternal sociodemographic, obstetric, and health and health behaviour

characteristics. The woman’s height was measured at this interview and using self-

reported pre-pregnancy weight, pre-pregnancy BMI was calculated.

Pregnancy symptoms. Women were asked to describe their pregnancy symptoms at

12, 20, 28 and 36 weeks. Based on women’s qualitative descriptions of their

symptoms at each time point, separate dichotomous variables were created for

nausea/vomiting and fatigue. For each symptom, women who reported having had the

symptom were coded as “Yes”, and women without this symptom were coded as

“No”.

The number of symptoms reported by women was also used to create variables

showing the total number of symptoms reported at each time point. These variables

were categorised as: 0-1; 2-3; 4 or more.

Low back pain. The Roland-Morris Disability questionnaire (RDQ-24) is a self-report

questionnaire assessing the level of physical disability resulting from low back pain.

The questionnaire contains 24 statements describing symptoms of low back pain, and

individuals are asked tick only those statements which apply to them on the day of

completion. Total scores range from 0 to 24, with higher scores indicating greater

disability. The RDQ-24 has been shown to be a reliable measure of low back pain that

has been validated in a number of populations and countries. Internal consistency for

the scale is good with Cronbach’s alpha ranging from 0.84 to 0.93[22].

Statistical Analysis

All analyses were conducted using STATA version 10.0 (StataCorp, Texas, USA).

Univariate differences between the groups on the sociodemographic, obstetric,

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physical and mental health and health-related variables, and pregnancy symptoms,

were examined using chi-square tests for independence and Fisher’s exact tests for

categorical variables, and unpaired t-tests for continuous variables. Women were

included in the analyses at each time point if they had data on the PPAQ.

Results

Participant Characteristics

The mean age of the sample (n=50) was 30 ±5yrs and slightly more than half of

women were married and had at least one child (Table 1). Most women (74%)

reported being in either part-time or full-time employment at 12 weeks gestation and

30% were tertiary educated. Almost one fifth of women had a history of miscarriage

and 26% had had a previous caesarean section. The median pre-pregnancy weight was

90kg and 36% of women had a BMI greater than 35 kg.m-2, but smoking rates were

relatively low (6%). At 12 weeks gestation, nausea and fatigue affected 78% and 54%

of women, respectively. Back pain affected 6% of women at 12 weeks and increased

to 30.5% at 36 weeks gestation. Characteristics of the women according to their group

allocation in the randomised control trial have been published elsewhere [17].

Energy Expenditure

Table 1 shows the proportion of women who were classified as Exercisers and Non-

exercisers. At 12 weeks gestation, the proportion of Non-exercisers (66%) was almost

double that of Exercisers (34%). Therefore, more than half of the women were not

achieving greater than 900 kcal of exercise per week. Athough there was a marked

decrease in the proportion of Non-exercisers at 20 (40%) and 28 (41%) weeks, the

percentage of Non-Exercisers increased to 57% at 36 weeks. Data derived from the

semi-structured interviews with the women conducted as part of the RCT showed that

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walking was the preferred method of exercise over the course of the trial, although a

wide variety of activities were undertaken [23].

Predictors of Exercise in Early Pregnancy

Table 1 shows the selected sociodemographic, obstetric, health and health behaviour

predictors of exercise at 12 weeks gestation for women who were classified

Exercisers and Non-exercisers. Pre-pregnancy weight and a history of previous

miscarriages were associated with exercise status. Exercisers were more likely to have

a lower pre-pregnancy weight (z = 2.74, p = 0.006) and a history of miscarriage than

non-exercisers (p = 0.047, Fisher’s exact test). The number of children living at home

was also a determinant of exercise status. At 20 weeks, Exercisers were more likely to

have at least one child living at home than Non-exercisers χ2(df = 1, N = 42) = 4.29, p

= 0.038.

Predictors of Exercise in Late Pregnancy

Educational attainment was a significant predictor of exercise in late pregnancy (see

Table 1). At 36 weeks, women who had completed tertiary education were three times

more likely to be an Exerciser (p = 0.02, Fisher’s exact test). At 28 weeks, women

who were randomised to the intervention group in the RCT were more likely to be

classified as an Exerciser χ2(df = 1, N = 41) = 3.94, p = 0.047, and there was also a

trend towards Exercisers being slightly younger than the Non-Exercisers (p = 0.09,

Fisher’s exact test).

Pregnancy Symptoms

Self-reported pregnancy symptoms were associated with exercise status during

pregnancy (Table 2). Specifically, women classified as Exercisers were less likely to

report nausea or vomiting at 28 weeks gestation than Non-exercisers (p = 0.01,

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Fisher’s exact test). Differences between the Exercisers and Non-exercisers were also

found for low back pain. The distributions of low back pain for the Exercisers

and Non-exercisers showed that Exercisers were more likely to report fewer

symptoms of back pain than Non-exercisers (z = 1.99, p = 0. 047). There were no

significant differences between the groups for fatigue and poor sleep at any point

during pregnancy.

Discussion The aim of the study was to examine the correlates of exercise among obese women

in early and late pregnancy. Although relevant sociodemographic, health behaviour

variables and pregnancy symptoms were associated with exercise status in this study,

the only obstetric variable to show an association with exercise status was previous

miscarriages. Women who had a history of miscarriage were more likely to be

Exercisers very early in pregnancy. This is likely to reflect the fact that many

pregnant women who have a history of pregnancy loss are anxious about future loss

and may subsequently adopt healthier lifestyles in an attempt to prevent future

miscarriages [24, 25].

Sociodemographic variables, including the number of children living at home and

education were associated with exercise status in this study. We found that women

with at least one child living at home were more likely to be classified as Exercisers,

which is contrary to other evidence showing that women with children at home are

less likely to be physically active [6, 9, 10]. It is possible that the women in our study

with children were also not currently working, or had children who were older and in

school. This may have allowed the women to have more time to exercise accounting

for our findings. We found that education was a predictor of exercise status in late

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pregnancy. Consistent with previous findings [6, 8, 9, 26], women classified as

Exercisers were more likely to have completed tertiary education than Non-

exercisers. Our findings are not unexpected considering that the link between obesity

and low socio-economic status has been previously established [27]. Social

disadvantage is associated with a range of poor health behaviours, and thus obese

pregnant women who come from disadvantaged backgrounds may benefit from

greater intervention. Pre-conception counselling may be particularly important for this

group of women. However, low socio-economic status is generally associated with

poor access to health services and this, in combination with the low rates of planned

pregnancies [28], suggests that community-based interventions for these women may

need to be considered as a feasible alternative. The fact that women assigned to the

intervention group in the RCT were more likely to be classified as Exercisers in late

pregnancy suggests the importance of providing support for obese pregnant women to

facilitate long-term health behaviour change.

Pregnancy symptoms were also associated with exercise status during pregnancy.

Women who reported lower back pain at 12 and 20 weeks and nausea or vomiting at

20 and 28 weeks were less likely to be classified as Exercisers. These findings are

consistent with other evidence suggesting that exercise in early pregnancy is related to

decreased reporting of nausea and vomiting in late pregnancy.[12] However, the

direction of the relationship between these pregnancy symptoms and exercise in our

study was not clear. The findings may suggest that exercise helps alleviate nausea and

vomiting in pregnancy. Alternatively, women may have chosen to exercise because

they experienced less nausea or vomiting during their pregnancy. In this study we

found physical health differences between the Exercisers and Non-Exercisers.

Specifically, pre-pregnancy weight in the Exercisers was lower at 12 weeks gestation

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than in the Non-exercisers. The differences between the groups for back pain found in

early pregnancy also support this, and are consistent with evidence suggesting that

pre-pregnancy physical activity is associated with a reduced risk of back pain during

pregnancy.[14] Further work is required to determine if this is a causal relationship.

In our study, it is unclear whether women who have less back pain are more likely to

exercise, or whether women who do exercise benefit from a reduction in back pain.

A major issue with lifestyle interventions is the assessment of physical activity. Both

subjective and objective measures of physical activity have well known limitations

(27). The PPAQ was very useful measure in our study – easy to complete and tailored

to measure physical activity among women during pregnancy. The self-report nature

of the questionnaire meant that we relied on the women to accurately recall their

activity, and this may have led to an overestimation of exercise hours. Thus, our

results may not generalise to other studies, particularly those relying on objective

measures of exercise.

In the RCT, a number of women withdrew from the trial at different stages, limiting

the data that was available for analysis over the course of the trial. A total of five

women (n = 3, control; n = 2, intervention) dropped out soon after their baseline visit.

Three women withdrew from the trial when they discovered they had been

randomised to the control group and were disappointed with this outcome. Two

women who were randomised to the exercise arm also withdrew at 12 weeks when

they were diagnosed with gestational diabetes based on their baseline blood tests.

Among the remaining women, those that withdrew from the study (n = 4, control; n =

5, intervention) did so because of medical or obstetric complications (e.g. miscarriage,

intrauterine fetal death, sacroiliac joint instability, gestational diabetes); five women

delivered before 36 weeks and thus did not have data collected at 36 weeks. The

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retention rates in the RCT and the reasons for non-completion have been published

elsewhere [18].

The small sample size in our study limited our ability to adjust for other variables,

including age and pre-pregnancy BMI. The women who remained in the study may

represent a highly motivated group, which may limit the extent to which these results

generalise. The results of this small pilot study suggest that it may be important to

adjust for sociodemographic variables (e.g. age, education), as well as pre-pregnancy

BMI in future analyses examining the correlates of exercise in pregnancy.

Conclusions This is the first study to identify the correlates of exercise during pregnancy in an

obese population. We found that health-related variables tended to predict exercise in

early pregnancy whereas sociodemographic variables were most likely to predict

exercise in late pregnancy. Specifically, women who had a history of miscarriage; a

lower pre-pregnancy BMI; who reported no nausea and vomiting; and who had no

lower back pain, were those women who were most likely to have exercised in early

pregnancy. Exercise in late pregnancy was most common among women who were

better educated, and there was a trend for younger women to be classified as

Exercisers during the third trimester of pregnancy. However, the direction of the

relationship between exercise and pregnancy symptoms is unclear and requires further

examination using larger samples prospectively designed to answer these questions.

The findings may be particularly useful for researchers who are designing

interventions aimed at reducing or controlling weight gain in obese pregnant women.

Interventions that offer greater support to women from disadvantaged backgrounds,

and closer monitoring of women who report persistent nausea and vomiting or lower

-15-

back pain during pregnancy may be beneficial. Providing this care and support may

be an initial step towards increasing obese women’s participation in exercise during

pregnancy.

-16-

Competing interests None

Authors Contributions KFF: Has been involved in design of the study, data collection, analysis and drafting the manuscripts. IJR has made substantial contributions to the statistical analysis of data and drafting of the manuscript. NMB has been involved in interpretation of the data and revising the intellectual content. HDM was involved in study design and revision of the intellectual content. LKC has been involved in the design of the study, obtained funding, provided oversight of the data collection and data analysis and revision of the intellectual content. All authors have read and approved the final manuscript.

Authors’ information KFF: RN, Research Midwife.

IJR: BPsycSc(Hons), PhD. Postdoctoral Research Fellow at University of Queensland and Queensland Institute of Medical Research.

NMB: BHMS, MAppSc, PhD.

HDM: MBBS (Hons), FRACP.

LKC: MBBS (Hons), FRACP, PhD.

Acknowledgments:We would like to thank the entire BAMBINO group from the Royal Brisbane and Women’s Hospital, Brisbane, Australia, for their contribution to the project – Susie Croaker, Dietitian- Nutritionist, Department of Nutrition and Dietetics – Xanthe Sansome, physiotherapist and research assistant – Briony O’Connor, physiotherapist and Ainsley Groves, exercise physiologist, School of Human Movement Studies, QUT. We would also like to thank Alison Barry, Dr Karin Lust, Dr Sophie Clarke, Barbara Waters, Kellie Himstedt, Dr Jon Hyett, and Dr Lynda Gillen for their support and contribution to the project and the midwives from Maternity Outpatient Department (MOPD), the birth suite and the labour ward.

Funding The BAMBINO project was supported by a Royal Brisbane and Women’s Hospital foundation strategic initiative grant.

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15. Callaway LK, Prins JB, Chang AM, McIntyre HD: The prevalence and impact of overweight and obesity in an Australian obstetric population. The Medical journal of Australia 2006, 184(2):56-59.

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16. Gore SA, Brown DM, West DS: The role of postpartum weight retention in obesity among women: a review of the evidence. Ann Behav Med 2003, 26(2):149-159.

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Tables

Table1 . Sociodemographic, health, obstetric, and health behaviour

predictors for women classified, Exercisers and Non-exercisers during pregnancy

12 wt<' ks' 20 w,..ks' 2S .HtkJ' 36 " 'teks'

\',\KI,\8lt: n~JJ n~ 17 /I ~ 18 ,,"'.l4 /I ~ 17 1I~24 II~ 2. lI~ l S

,'lion- h t ITi!;t r$ Non- En rci $l'l"$ "'on- Eu rciStI'1 Non- E~ t rri$l'rs

he«iStrs htrdstrs herl'i !>t1'S .:. t rdstrs

RC I" study group

CQ1Ilrol 18 (550/0) 7(41%) 10 (63%) 9(38%) 11 (65%) 8(33%) I1 (S5Y. ) 5 (330/0)

Imen 'en/ion 15{4S0/0) 10(590/0) 6(38%) 15(630/.) 6 (350/. ) 16 (67%) 9(450/0) 10 (670/0)

P 0.31' 0,12 ' 0.1)47) 0.20'

Age M (SIl ) 30.0(5.7) 30.5 (4.1) 29.6 (5.4) 30.3 (5.2) 31.9 (4.5) 29.1 (5 .4 ) 29.4 (H) 32.1 (U)

P 039 0.10 0.09 0.12

THli Rry 10 (JW. ) 5 (3W.) 4(22%) II (46%) 5 (290/0) 10 (42%) 4 ( IW o) 9 (600/0)

P 0.95 ' O , l ~ 0,42 ' 0.02'

Mari lal Slarus

Married 24(730/0) 9(53%) 10(56%) 17 (71 %) 9 (530/0) 17 (71 %) 13 (62%) 10 (67"/0)

P 0,16 ' 0.31' 0. 2~ ' 0.77 '

[mplo~·td 24(730/0) 13 (7Wo) 16 (89-/0) 17(710/0) 16 (9~%) 17 (81 %) 18(86%) I1 (73%)

P 0,77) 0,2<r 0.11 ) 0.42 )

~ 1 r hild a t humt 18 (55%) 12 (7 1%) 7 (39%) 17(81%) 8 (47% ) 16 (67%) 14 (67"4 ) 9 (6O'ro)

P 027) 0.038 ' 0.21' 0.68'

Pn-"ious 3 (9-10) 6 (35%) 1(6%) 6\25%) 1 (6% ) 6(25%) 3 (140/0) 4 (270/0)

misurriages

p 0.0~7' 0,21 0 .21 0.42

1'rn iuus catprnn 8 (24%) 5 (2 ('Y~) 3(17%) 7(33%) 3(180/0) 7 (29%) 3( 14%) 6(40% ~ftion

p 0,69' 030' 0.48' 0.12'

SmokH 3(9%) 0(00/0) 2( 11%) 1 (4%) 2 ( 120/0) 0 (0%) 2(10%) 0(0%)

, 0,54' 0,57) 0. 17) 0.501

Prf-p rf'gna nfY 93(75·176) 85 (68·95) 92 (75 ·176) 87.5(68· 93(68·1 76) 87.5 (78· 93(68· 175) 89 (78.2·

"righ t 105) 115) 176)

P 0.0 11 0.3]1 0.481 0.521

ll iSlOr)' oFmt nlal 11 (33%) 8(47%) hea lth diagnostS

7 (39%) 8(33%) 6(35%) 8 (33%) 9(43%) 4 (270/0)

P 034' 0, 7 1' 0.89' 0.32'

Note. IChi -sqaure test. lMann-Whitney lest. Data for pre-pregnaney weight is presented as: Median (range). 3Fisher's exaet test. 4Numbers may not sum to total beeause some data missing

-20-

V,\RI,\UI..:

Table 2. Number of pregnancy symptoms: nausea, vomiting, fatigue, low back pain during pregnancy in PPAC Exercisers versus PPAQ Nonexercisers

11 .. · ....... • 20 .. · ....... • 23 .. · ..... • .16 ............

~ . jj ,._17 1f · I8 .·U ,, · 17 ,._u ,, · 21 n· l~

~O. Or s,'mpl0 m. "·OR~"r<;"'", .;..~"';,.-'" "·oR-t: ,e",i>t'" t: ,t"';"-" ~on-t: 't"';"-", h • ...,i>t", ,",on_ .: ,.",i ... ", .:..",;,-", ,-, 9(27" . ) 4 (24· . ) 5 (28".) 14 (~go.) 4 (24·.) 10(42"'.) 2 (10".) 3 (20".)

,-, 1 1(S2"'~) 11 (6S·.) 10(36· .) 8(33· .) 1(41 '.) 12(SOO.) 14 (70'.) 9(60" . )

4 Or moll: 1 (21' 0) 1 (12'! .) 3 (17".) l(~.) 6(35·.) 2(3'~) 4(~.) 3 (2(I'Y,)

, 0.72' O. IS' .,.. 0.88'

Sou..a& 3 (1 4~.) 6(37". ) 8 (44'.) 3( 13~.) 7(41-.) 1(4%) IWo) 2(13%)

\·omitin~

, 0.136' QClJ3' '"'" O.S6S'

" .fig .. 11(S2~.) 11(65· .) 3 (17".) '1(38'. ) 7(41 '.) 3(m.) 3 (IS'.) 2 ( 1 3~,) , 0.)7' 0.18' 0.6:1' 1.00'

" ," 32 ,." 16 " ," 14 .·ll ,, _ IS .·ll ,, '" 21 ,." 14

n.ok I'~in 1 (0-15) 0(0-7) 3 (0-14) 0(0-10) 1 (0-8) 2(0-1~) 3 (0-19) 2 (0-24)

, 0.001'>' 0.1l.I' ,.w 0.25'

Nofe. lChi-sqaure test. 2Mann_ Whitney test. Data for back pain is presented as: Median (range). 3Fisher's exact test. 4 Numbers may not sum to total because some data missing.

-22-


88

Appendix 3 Letter of Invitation

Royal Brisbane and Women’s Hospital

Health Service District

Division of Medicine, Department of Internal Medicine Internal Medicine Research Unit

Enquiries to: Katie Foxcroft Research Nurse

Phone: 07 3636 5164 Fax: 07 3636 5737 Dear You are invited to participate in a research project being conducted at the Royal Brisbane and Women’s Hospital. We are interested in hearing about symptoms women have during their pregnancy. We will be conducting a couple of informal discussion groups to record symptoms you may be experiencing so that we can develop a symptoms inventory or survey that is relevant to all pregnant women. We would then like to road test the survey to make sure it is relevant to pregnant women, well understood and user friendly. If you are interested in participating in these discussion groups and currently less than 12 weeks pregnant, we would invite you to consider participating in this study. Further information is available by calling me on 36365164. Regards Katie Foxcroft Principal Investigator


89

Appendix 4 Survey of Midwives who used the PSI

Survey of Midwives who used the Pregnancy Symptoms

Survey in MOPD March 2008 Instructions Please give your answer by putting a vertical line through the horizontal line. How useful did you find the Pregnancy Symptoms Survey at identifying symptoms??

Very Useful

Did you refer anyone for further assistance eg physio, incontinence nurse or mental health? Yes No (Please circle) Please make any other comments or suggestions for improvement. (Optional) ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________


91

Appendix 5 Inventory completed by women included

in the study


94

Appendix 6 Permission from the Ethics Committee

, '

Queensland Government

Royal Brisbane & Women's Hospital & Health Service District Office of the Human Research Ethics Committees

30 November 2006

Ms Katie Foxcroft Commercial Studies Coordinator Internal Medicine Research Unit RBWH

Dear Ms Foxcroft

Queensland Health

Enquiries to: Coordinator

Phone: 07 3636 5490

Fax: 0736367800

Our Rei: 20061125 E-mail [email protected].

gov.au

PROTOCOL 2006/125: DEVELOPMENT AND VALIDATION OF A PREGNANCY SYMPTOMS INVENTORY

At a meeting of the Royal Brisbane & Women's Hospital Human Research Ethics Committee held on 25 September 2006, the Committee reviewed the above Protocol. The Royal Brisbane & Women's Hospital Human Research Ethics Committee is duly constituted, and operates and complies with the National Health and Medical Research Council's 'National Statement on Ethical Conduct in Research Involving Humans and Supplementary Notes, 1999'. The Chair of the HREC reviewed your further correspondence on the 27 November 2006.

tt is advised that on the recommendation of the Human Research Ethics Committee, the Clinical Chief Executive Officer, Royal Brisbane & Women's Hospital has approved your request for ethical approval of the following:

• Protocol V1. 1 dated 2410812006 • PICF V2 dated 1611112006 • Recruitment Letter • NEAF dated 10111106 •

During the conduct of the study you are required to adhere to the following conditions:

• If recruitment has not commenced within 12 months, please advise the Coordinator, HREC.

• All forms required when submitting reports to the HREC are accessible on the Herston Intranet. In the first instance please access the Commencement Form and return to this office when the study commences. Please contact the Coordinator if you do not have access to this site.

• In accordance with RBWH Policy 72005: Clinical Trial Documentation, all medical records of research participants must contain documentation regarding the patient's involvement in the trial.

• All investigations must be carried out according to the "Declaration of Helsinki 2000" as subsequently modified and the latest statement by the National Health and Medical Research Council on Human Experiments and on Scientific Practice. Should a copy of the 'Declaration of Helsinki 2000' as subsequently modified be required, please request a copy from the Coordinator, Human Research Ethics Committee.

• Attachment I is a letter listing some matters specified by the National Health and Medical Research Council to which you as the research worker must adhere.

Office

Herston Rd Herston Q 4029

Postal

Post Office Herston Queensland 4029 Australia

Phone

0736365490

ISD + 61 7 3636 5490

Fax

0736367800

• Attachment 11 gives the Committee composition with specialty and affiliation with the Royal Brisbane & Women's Hospital.

• You are required to provide a report on any pilot study and the outcome of the study at the completion of the trial or annually if the trial continues for more than 12 months.

• If any subsequent change/amendment is made to the protocol it will be necessary for you to obtain approval from the Human Research Ethics Committee. In addition a summary of the amendments and a comment is required from the Principal Investigator. All amended documents must contain revised version numbers, version dates and page numbers. Changes must be highlighted using Microsoft Word "Track Changes" or similar. Please contact the HREC Coordinator if assistance is required.

• Serious Adverse Events must be notified to the Committee as soon as possible. In addition the Investigator must provide a summary of the adverse events, in the specified format, including a comment as to suspected causality and whether changes are required to the Patient Information and Consent Form.

• If the results of your protocol are to be published, an appropriate acknowledgment of the Hospital should be contained in the article. Copies of all publications resulting from the study should be submitted to the Human Research Ethics Committee.

• Please ensure that a copy of any publication that results from this protocol is also forwarded to the Herston Medical Library for future reference.

• The Hospital administration and the Human Research Ethics Committee may inquire into the conduct of any research or purported research, whether approved or not and regardless of the source of funding, being conducted on hospital premises or claiming any association with the Hospital; or which the Committee has approved if conducted outside the Royal Brisbane & Women's Hospital Health Service District. This may include consultation with the Principal Investigator and/or a visit to the research site by a member of the HREC and/or Coordinator of the HREC.

Should you have any problems, please liaise directly with the Chairperson of the Human Research Ethics Committee early in your program.

We wish you every success in undertaking this research.

Yours faithfully

FM ;1j?----for Clinical CEO

Royal Brisbane and Women's Hospital Health Service District

Office

Herston Rd Hers!on Q 4029

Postal

Post Office Herston Queensland 4029 Australia

Phone Fax

0736365490 0736367800

ISD + 61 7 3636 5490


97

Appendix 7 Participation Information and Consent

Form


101

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