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February 2011 PREVENTION OF POSTPARTUM HEMORRHAGE AT HOME BIRTHS: Misoprostol Distribution during Antenatal Care Visits in Tanzania FINAL REPORT

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Page 1: IHI-VSI Miso Project Report 2011 02 16 FINALbixby.berkeley.edu/wp-content/uploads/2015/03/IHI_VSI_Bixby_MOHSW_PSI... · Albert Kitumbo, Emma Nesper and Calandra Park . iv Executive

February 2011

PREVENTION OF POSTPARTUM

HEMORRHAGE AT HOME BIRTHS:

Misoprostol Distribution during

Antenatal Care Visits in Tanzania FINAL REPORT

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ii

Ifakara Health Institute (IHI) is an autonomous, nonprofit organization registered in Tanzania focusing

on health research. The mission of IHI is to develop and sustain a district-based health research and

resource center capable of generating new knowledge and relevant information for public health policy

and actions.

Venture Strategies Innovations (VSI) is a California-based nonprofit organization committed to

improving women’s health in developing countries by creating access to effective and affordable

technologies on a large scale. VSI’s innovative approach involves partnerships that build upon existing

infrastructure, resources and markets. VSI focuses on reducing barriers to access and enhancing human

capacity to bring about sustainable improvements in health.

Bixby Center for Population, Health and Sustainability is a research center within the University of

California, Berkeley School of Public Health. The Center is dedicated to developing innovations to

improve reproductive health in resource-poor settings, including reliable health information systems,

local access to essential technologies, and guidelines for prioritizing interventions to maximize health

impact. The Center assists in the implementation of maternal health programs and seeks to improve the

health outcomes of the world’s poorest and most vulnerable women and their families.

Population Services International (PSI)/Tanzania

PSI is a leading global health organization with programs targeting malaria, child survival, HIV,

reproductive health and non-communicable disease. PSI’s mission is to measurably improve the health

of poor and vulnerable people in the developing world, principally through social marketing of family

planning and health products and services, and health communications.

Ifakara Health Institute

P. O. Box 78373

Plot 463, Kiko Avenue

Mikocheni

Dar es Salaam, Tanzania

Tel +255 222 774 714 / +255 222 774 756

Website: www.ihi.or.tz

Venture Strategies Innovations

2401 East Katella Avenue

Suite 400

Anaheim, California 92806 USA

Tel +1 714 221 2040

Website: www.vsinnovations.org

Bixby Center for Population, Health and

Sustainability

School of Public Health

17 University Hall

University of California

Berkeley, California 94720-7360 USA

Tel +1 510 643 7627

Website: www.bixby.berkeley.edu

PSI/Tanzania

Haile Selassie Road

Masaki Msasani Peninsula Area

Plot No. 1347/48

P.O. Box 33500

Dar es Salaam, Tanzania

Tel +255 222 602 742

Website: www.psi.org/tanzania

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iii

Acknowledgements

We wish to acknowledge our collaborators in Tanzania who shared their wealth of experience as we

developed this pilot program and field handbook. By sharing their knowledge of community health

programs, monitoring and evaluation, and delivery of health care in Tanzania, they aided us in our effort

to increase access to the life-saving drug misoprostol among women in low-resource settings with high

rates of home births unattended by skilled providers, and in countries that witness tragic numbers of

maternal deaths annually.

We wish to thank expert staff and colleagues at the Ifakara Health Institute (IHI) in Tanzania for their

dedication to the project and invaluable contributions to its development. Dr. Godfrey Mbaruku, Project

Director of the Empower Project, provided valuable insight in developing this handbook for the Tanzania

context. Dr. Albert Kitumbo, Project Coordinator, worked tirelessly to prepare and coordinate this

project. IHI staff, including Selamani Mbuyita and Idda Kinyonge (Community), Felix Lubuga

(Information, Education, Communication), Hadija Kweka (Monitoring and Evaluation), Abdallah Mkopi

(Data Management) and Silas Temu (Information Technology) provided oversight of the project’s

development and implementation. Lastly, we wish to acknowledge District Coordinators Betty

Ndaletuke, Dr. Said Mkikima, Ester Ntyangiri and Dr. Samwel Likasi and the antenatal care providers and

the traditional birth attendants whose dedication to the women of Tanzania was the cornerstone of this

project.

We are indebted to the staff of Venture Strategies Innovations (VSI) and the Bixby Center for Population,

Health and Sustainability at the University of California, Berkeley for their tireless support, which made

this project possible. Senior Program Manager Alisha Graves managed the planning and implementation

of the project in collaboration with Dr. Emmanuel Rwamushaija, VSI National Program Coordinator. Amy

Grossman, Director of Communications and Development at VSI, assisted in the initial development of

the training materials. This work commenced under Venture Strategies for Health and Development,

VSI’s sister organization.

PSI also deserves recognition for contributing the misoprostol tablets used in the project.

Most importantly, we wish to thank the women and communities in Kigoma Urban, Kilombero, Ulanga

and Rufiji districts of Tanzania for welcoming us, participating in the project, and sharing their

experiences.

Prepared by:

Ndola Prata and Martine Holston

Additional Contributors:

Albert Kitumbo, Emma Nesper and Calandra Park

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Executive Summary

While the maternal mortality ratio in Tanzania has decreased in the last decade, the current maternal

mortality ratio of 454 maternal deaths per 100,000 live births (TDHS, 2010) is still higher than the figure

targeted to reach the fifth Millennium Development Goal by 2015. The leading cause of maternal

mortality globally is postpartum hemorrhage (PPH). Since many women do not present with risk factors,

PPH prevention is extremely important, especially in Tanzania where women may have limited access to

care and over half of deliveries take place outside of a health facility. Misoprostol is a safe, effective and

affordable tablet that has been shown to reduce postpartum bleeding; it was approved by the Tanzanian

Food and Drugs Authority for the prevention and treatment of PPH in September 2007.

In late 2007, the Ministry of Health and Social Welfare (MOHSW) of Tanzania convened Ministry staff,

local experts, and local and international non-governmental organizations (NGOs) working on maternal

health for a technical consultative meeting. Following this, a working group drafted the “Guidelines for

use of uterotonics in active management of the third stage of labour,” which were published by the

MOHSW in 2008. The MOHSW-appointed working group recommended an operations research project

that would demonstrate that antenatal care (ANC) education on PPH prevention and distribution of

misoprostol are appropriate means for addressing PPH in the context of Tanzania’s health system.

The goal of this project was to save mothers’ lives by increasing the number of women protected from

PPH with a uterotonic drug, particularly at home births. Results from this project will inform the

development of a model that can be applied throughout Tanzania as well as in other countries,

especially in settings where the majority of women deliver without a skilled attendant. The project was

comprised of two components: a community awareness campaign on birth preparedness and PPH

prevention; and distribution of misoprostol tablets to pregnant women during ANC to prevent PPH in

the event they were unable to reach a facility to deliver. The campaign utilized radio messaging, printed

materials, and one-on-one interaction to communicate the main messages of the campaign, with

primary emphasis on the project’s tagline, “Plan early for a safe delivery.” During routine ANC visits,

providers educated women on safe delivery and PPH prevention, including information on misoprostol,

enrolled assenting women aged 18 or older, screened women for eligibility to take misoprostol tablets

home, and dispensed the tablets to women at 32 weeks or greater gestational age.

The project was conducted in four districts in Tanzania: Kigoma Urban, Kilombero, Ulanga and Rufiji. All

facilities in these four districts that provide ANC participated in the project. Enrollment in the project

began in mid-January 2009 and continued until mid-January 2010. ANC providers enrolled 97% of

women coming to ANC, recruiting 12,511 women to participate in the project. Postpartum interviews

were conducted with approximately half (54%) of women enrolled in the project. Of those, 1,826 used

misoprostol for PPH prevention at a home birth.

The campaign was effective in reaching women, with 96% of postpartum interview respondents stating

that they had received information on PPH. Health providers and facilities were the most frequently

cited sources of information about bleeding after childbirth (97%). Posters/pamphlets (34%), radio

(22%), community health worker (21%), friend/relative (16%) and traditional birth attendant (15%) were

mentioned less frequently as sources of information about PPH. Midwives and health facilities were

mentioned as the most important source of misoprostol information across the four districts (85% to

94%), with the other sources listed in very small numbers. Overall, recall of the community awareness

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campaign messages was high amongst participants in the postpartum interview sample. Almost all

respondents in the postpartum interview knew the function (98%), correct timing (98%), correct dose

(98%) and correct route (98%) of misoprostol for PPH prevention.

While we anticipated that all women would return for an ANC visit at least once after they reached 32

weeks gestation (i.e. when they became eligible to receive misoprostol), only 44% of enrolled

participants attended ANC after 32 weeks. Of women who returned after 32 weeks, almost all (97%)

took misoprostol home with them. Of the 2,075 home deliveries reported amongst the postpartum

interview respondents, 88% used misoprostol received during an ANC visit.

Among the more than 6,500 women who participated in the postpartum interview, 91% were protected

from PPH by either receiving an injection at a health facility (41%), misoprostol at a health facility (23%),

or misoprostol at home (27%). Misoprostol use at home deliveries protected an additional 27% of

deliveries that would not have been protected were it not for misoprostol distribution at ANC.

Most of the women delivered at a health facility regardless of whether they received misoprostol at

ANC. Of those who took misoprostol home from ANC and delivered at home, most used misoprostol at

delivery (96%). Women who delivered at home and did not use misoprostol were more likely to needed

additional interventions than women who used misoprostol (6% vs. <1% respectively). Additionally,

more interventions were needed per woman.

Overall, bleeding-related referrals were low amongst women who participated in the postpartum

interview; only 30 women reported requiring referral for bleeding-related causes (<1%). Of those

women referred, fewer than half reported receiving interventions at the health facility, mostly

intravenous fluids, manual removal of placenta, and injection.

No woman who took misoprostol at home reported taking either a dose or using a route different from

what they had been educated on during ANC and in the community awareness campaign (three tablets

taken orally). Therefore, correct misoprostol use was nearly universal (98%) among participants who

used the drug at a home delivery for PPH prevention (2% did not respond to these questions).

Almost four out of five women did not experience any symptoms during the postpartum period (79%).

The most common symptoms experienced were shivering (13%), nausea (5%), and increase in body

temperature (4%). Misoprostol users were significantly more likely to report experience of these three

symptoms.

Acceptability of misoprostol was high amongst users and non-users alike. Almost all women would

recommend misoprostol to a friend (98%), use misoprostol in a subsequent delivery (96%), or purchase

misoprostol (95%).

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Acronyms and Local Terms

ANC Antenatal care

CORPs Community resource persons

IHI Ifakara Health Institute

Kanga A locally produced pre-cut rectangular piece of fabric worn by local women and used to

collect (and assess) blood loss after delivery

MOHSW Ministry of Health and Social Welfare

NGO Non-governmental organization

PDA Personal digital assistant

PPH Postpartum hemorrhage

TBA Traditional birth attendant

TBC Tanzania Broadcasting Corporation

TSH Tanzanian Shilling

UCB University of California, Berkeley

VSHD Venture Strategies for Health and Development

VSI Venture Strategies Innovations

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Table of Contents

Acknowledgements ...................................................................................................................................... iii

Executive Summary ...................................................................................................................................... iv

Acronyms and Local Terms .......................................................................................................................... vi

1. Introduction .............................................................................................................................................. 1

1.1 Postpartum Hemorrhage in Tanzania ................................................................................................. 1

1.2 Misoprostol for Prevention of PPH ..................................................................................................... 1

1.3 History of Misoprostol in Tanzania ..................................................................................................... 2

1.4 Rationale for Misoprostol Distribution at ANC for Prevention of PPH at Home Births ...................... 3

2. Project Description .................................................................................................................................... 4

2.1 Project Goals and Objectives .............................................................................................................. 4

2.2 Location ............................................................................................................................................... 5

2.3 Project Timeline .................................................................................................................................. 5

2.4 Ethical Review ..................................................................................................................................... 6

3. Methods .................................................................................................................................................... 6

3.1 Strategy and Design ............................................................................................................................ 6

3.2 Information, Education and Communication Campaign Components ............................................... 6

3.3 Project Personnel and Training ........................................................................................................... 8

3.3.1 Organizational Structure .............................................................................................................. 8

3.3.2 Training Structure ........................................................................................................................ 8

3.4 Data Management and Analysis ......................................................................................................... 9

3.4.1 Data Collection Tools ................................................................................................................... 9

3.4.2 Data Entry and Management ....................................................................................................... 9

3.4.3 Data Analysis ................................................................................................................................ 9

4. Results ....................................................................................................................................................... 9

4.1 Characteristics of the Participants .................................................................................................... 10

4.2 Community Awareness Campaign Coverage and Comprehension of Messages ............................. 12

4.3 Feasibility: Coverage of Misoprostol Distribution ............................................................................ 15

4.4 Program Effectiveness: Coverage of Misoprostol at Home Births and Births Protected from PPH . 16

4.5 Program Effectiveness: Bleeding-related Referrals and Need for Additional Interventions ............ 18

4.6 Program Effectiveness: Uterotonic Coverage and Need for Additional Interventions

at Home Births ........................................................................................................................................ 19

4.7 Safety: Correct Use of Misoprostol and Postpartum Symptoms ...................................................... 20

4.8 Acceptability: User Perspectives on Misoprostol Use ...................................................................... 21

5. Conclusions ............................................................................................................................................. 22

6. Recommendations .................................................................................................................................. 23

References .................................................................................................................................................. 25

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List of Boxes, Tables and Figures

Box 1: The Kanga as a Postpartum Blood Loss Assessment Tool ................................................................. 3

Table 1: Population, estimated births, ANC coverage and ANC resources in project districts .................... 5

Table 2: Data for analysis .............................................................................................................................. 9

Table 3: Background characteristics of the participants ............................................................................. 11

Table 4: Delivery characteristics ................................................................................................................. 12

Table 5: Women's report of receiving information on PPH ........................................................................ 13

Table 6: Women's report of receiving information on misoprostol ........................................................... 13

Table 7: Women's spontaneous response on information received on excessive bleeding and

misoprostol ................................................................................................................................................. 15

Table 8: Coverage of misoprostol distribution to enrolled clients at ANC visits ........................................ 16

Table 9: Reported uterotonic use at delivery ............................................................................................. 16

Table 10: Births protected from PPH .......................................................................................................... 17

Table 11: Referrals and additional interventions ....................................................................................... 18

Table 12: Correct use of misoprostol at home births ................................................................................. 20

Table 13: Reported experience of postpartum symptoms ......................................................................... 21

Table 14: Acceptability of misoprostol ....................................................................................................... 21

Figure 1: Project timeline .............................................................................................................................. 5

Figure 2: Community awareness poster ....................................................................................................... 7

Figure 3: Organizational structure of the project ......................................................................................... 8

Figure 4: Enrollment by month ................................................................................................................... 10

Figure 5: Average number of ANC visits by district .................................................................................... 11

Figure 6: Most important source of information on misoprostol by district.............................................. 14

Figure 7: Coverage of protected births at home vs. health facility deliveries ............................................ 17

Figure 8: Mode of transportation to the health facility of those referred ................................................. 19

Figure 9: Need for additional interventions at home births with and without misoprostol ...................... 20

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1. Introduction

1.1 POSTPARTUM HEMORRHAGE IN TANZANIA

While the maternal mortality ratio in Tanzania has decreased in the last decade, the current maternal

mortality ratio of 454 per 100,000 live births is still higher than the figure targeted to reach the fifth

Millennium Development Goal of 133 by 2015 (TDHS, 2010). The most common causes of maternal

death in developing countries include hemorrhage, obstructed labor, hypertensive disorders, sepsis and

unsafe abortion (Khan et al., 2006).

Postpartum hemorrhage (PPH) is defined as excessive bleeding (bleeding more than 500ml or bleeding

sufficient to cause deterioration in the woman’s clinical condition) after childbirth, and accounts for

approximately 34% of maternal deaths in sub-Saharan Africa (Khan et al., 2006). It is extremely difficult

to predict who will experience PPH. The average time to death from onset of PPH is two hours so any

delay in seeking health care can be deadly (Maine, 1993). Since many women do not present with risk

factors, PPH prevention is extremely important, especially in Tanzania where women may have limited

access to care and over half of deliveries take place outside of a health facility (NBS Tanzania and ORC

Macro, 2005).

There are several technologies that have proven effective at managing PPH. However, current methods

of PPH prevention and treatment – uterotonic agents such as oxytocin that cause the uterus to contract

and reduce postpartum bleeding – must be administered by injection, and require refrigeration to

preserve their potency. Consequently, there is a need for an effective means of preventing PPH for

deliveries that take place at home in low-resource settings.

1.2 MISOPROSTOL FOR PREVENTION OF PPH

Misoprostol is a safe, effective and affordable tablet that has been shown to reduce postpartum

bleeding. While injectable uterotonics such as oxytocin are relatively more effective than misoprostol

(Gülmezoglu et al., 2001), current evidence supports the use of misoprostol where oxytocin is infeasible

(Joy et al., 2003; Geller et al., 2006; Lagenbach, 2006; Alfirevic et al., 2007). Furthermore, several

features of misoprostol make it more feasible than oxytocin in areas where maternal mortality is the

highest (Derman et al., 2006). Misoprostol tablets to not require a skilled provider or safe injection

supplies to administer, and do not require special storage conditions. Misoprostol has been recognized

by the international community for its potential to reduce PPH-related morbidity and mortality in low-

resource settings due to its relative efficacy, ease of administration, and stability in field conditions

(Derman et al., 2006; Caliskan et al., 2003; Oboro et al., 2003). Extensive research has demonstrated

that 600mcg of misoprostol taken orally is the ideal dose for prevention of PPH and symptoms such as

shivering or nausea are generally self-limiting (Lumbiganon et al., 1999; Derman et al.,2006).

Beyond the published scientific evidence, international entities support misoprostol as a key

intervention for maternal health programs. The International Federation of Gynecology and Obstetrics

and the International Confederation of Midwives (FIGO/ICM) have recommended that in home births

where a skilled attendant is not present, misoprostol may be the only available technology to control

PPH (ICM/FIGO, 2006). A number of international agencies are now working in partnership with

ministries of health around the globe to introduce misoprostol for PPH prevention and to train providers

in its safe administration. Indeed, several countries in Africa have already included misoprostol for the

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prevention of PPH in their lists of essential medicines. Tanzania has been on the forefront of introducing

misoprostol at the community level to protect women delivering at home from PPH.

1.3 HISTORY OF MISOPROSTOL IN TANZANIA

The Tanzanian Food and Drugs Authority approved the import, sale and distribution of misoprostol for

the prevention and treatment of PPH in September of 2007. It was included in the 2007 edition of the

Tanzanian Standard Treatment Guidelines and National Essential Medicines List.

During 2003 and 2004, the Bixby Center for Population, Health and Sustainability at the University of

California, Berkeley (UCB) with support from Venture Strategies for Health and Development (VSHD)

conducted the Use of Misoprostol for Treatment of Postpartum Hemorrhage Study in Kigoma, Tanzania

to determine the ability of traditional birth attendants (TBAs) to identify and safely treat PPH at home

births using misoprostol. Thirty TBAs were selected and trained in intervention and non-intervention

(control) areas. All TBAs were trained to measure blood loss using a kanga for blood collection after

delivery, and to identify PPH as two or more kangas soaked with blood after the delivery of the baby

(see Box 1: The Kanga as a Postpartum Blood Loss Assessment Tool). TBAs in the intervention area were

instructed to administer 1000mcg (five tablets) of misoprostol rectally to women after identifying PPH,

and the TBAs in the non-intervention area were trained to refer women with PPH to the nearest health

facility. The Use of Misoprostol for Treatment of Postpartum Hemorrhage Study showed that TBAs could

effectively diagnose PPH and treat it at home births using misoprostol. The use of misoprostol reduced

the need for referrals and additional interventions due to misoprostol (Prata et al., 2005b).

After the conclusion of the study in 2004, TBAs in the intervention area continued to use misoprostol to

treat PPH at home births. Kigoma was one of the first districts in Africa to use misoprostol for household

management of PPH outside a research environment. In 2007, the principal investigators of the Use of

Misoprostol for Treatment of Postpartum Hemorrhage Study, Dr. Godfrey Mbaruku of the Ifakara Health

Insitute and Dr. Ndola Prata of the UCB School of Public Health in collaboration with VSHD and the

Maweni Regional Hospital in Kigoma, Tanzania, returned to the study areas to assess the long-term use

of misoprostol to treat PPH at the community level. TBAs who participated in the 2003-4 study identified

women from the same intervention and non-intervention areas who had delivered between August

2004 and May 2007, irrespective of whether they experienced PPH. Identification of PPH using the

kanga and subsequent use of misoprostol for treatment of PPH by TBAs resulted in fewer referrals and

less need for additional interventions due to excessive bleeding compared to control areas (Prata et al.,

2007).

In late 2007, the Ministry of Health and Social Welfare (MOHSW) of Tanzania convened Ministry staff,

local experts, and local and international non-governmental organizations (NGOs) working in maternal

health for a technical consultative meeting. Following this, a working group drafted the “Guidelines for

use of uterotonics in active management of the third stage of labour,” which were subsequently

published by the MOHSW in 2008. There was consensus among participants in the consultative meeting

that misoprostol was appropriate for community use as a complementary strategy for reducing PPH

while the country worked to increase facility births. The same working group drafting the guidelines

considered the various mechanisms for education and distribution of misoprostol for home births. The

MOHSW-appointed working group recommended an operations research project to demonstrate that

ANC education and distribution of misoprostol is appropriate in the context of Tanzania’s health system.

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Box 1: The Kanga as a Postpartum Blood Loss Assessment Tool

The kanga is a brightly colored piece of fabric worn by

nearly every woman in Tanzania. It can be wo

(sarong), a shawl or a head wrap, and is also used to strap

a baby to a woman’s back.

Focus group discussions, in-depth interviews, and

participant observation during the

Treatment of Postpartum Hemorrhage Study

TBAs typically place a kanga under the buttocks of a

woman immediately after delivery. The authors also found

that kangas are of standard size (100cm x 155cm),

when two are soaked with blood they measure slightly

more than 500ml (standard definition of PPH by the World

Health Organization) (WHO, 1990). The

utilized in the study as a means to measure postpartum

blood loss and to diagnose PPH (Prata

The finding that the kanga could be used as a

measurement tool for postpartum blood loss was itself

quite important. Already a part of standard delivery

practice at home births, the use of

PPH proved an easy and culturally acceptable way to train

TBAs to identify excessive blood loss.

measured blood loss using a threshold of three or four

kangas to determine excessive bleeding warranting referral. TBAs were waiting too long to seek assistance for

women experiencing PPH at home births, putting them at increased risk of maternal death. Use of a common

household item as a standard measure for blood loss provides an opportunity to educate TBAs and women

about when to seek assistance for PPH.

Measurement of blood loss through simple observation is inaccurate, even in clinical settings. The

provides a reliable and effective method of diagnosing PPH at home deliveries. If similar cloth items of standard

size can be found in other settings (

postpartum blood loss measurement tool, and women and TBAs should be counseled to know the threshold of

when to take action for excessive bleeding at home births.

1.4 RATIONALE FOR MISOPROSTOL DISTRIBUTION A

HOME BIRTHS

All women should be encouraged to deliver at a facility with a skilled attendant to prevent and manage

PPH and other complications at delivery. However, there continue to b

providers keeping women from receiving a uterotonic drug at delivery.

especially in the project districts (Kigoma

deliveries take place at home, additional strategies to reach women with life

as misoprostol are needed. More than 90%

once during pregnancy (NBS Tanzania and ORC Macro

opportunity to distribute misoprostol and enable those who cannot reach a facility

delivery to have access to this life-saving technology.

Recently published research demonstrates

self-administering misoprostol for PPH prevention

health worker and education on proper use

misoprostol is distributed for use at home

3

as a Postpartum Blood Loss Assessment Tool

is a brightly colored piece of fabric worn by

nearly every woman in Tanzania. It can be worn as a skirt

or a head wrap, and is also used to strap

depth interviews, and

bservation during the Use of Misoprostol for

Treatment of Postpartum Hemorrhage Study found that

under the buttocks of a

The authors also found

are of standard size (100cm x 155cm), and

when two are soaked with blood they measure slightly

more than 500ml (standard definition of PPH by the World

1990). The kanga was thus

utilized in the study as a means to measure postpartum

rata et al., 2005a).

could be used as a

measurement tool for postpartum blood loss was itself

quite important. Already a part of standard delivery

practice at home births, the use of kangas to diagnose

ulturally acceptable way to train

identify excessive blood loss. Previously, TBAs

measured blood loss using a threshold of three or four

to determine excessive bleeding warranting referral. TBAs were waiting too long to seek assistance for

omen experiencing PPH at home births, putting them at increased risk of maternal death. Use of a common

household item as a standard measure for blood loss provides an opportunity to educate TBAs and women

about when to seek assistance for PPH.

Measurement of blood loss through simple observation is inaccurate, even in clinical settings. The

provides a reliable and effective method of diagnosing PPH at home deliveries. If similar cloth items of standard

size can be found in other settings (such as the chitenge cloth in Zambia), they should be utilized as a

postpartum blood loss measurement tool, and women and TBAs should be counseled to know the threshold of

when to take action for excessive bleeding at home births.

OSTOL DISTRIBUTION AT ANC FOR PREVENTION

All women should be encouraged to deliver at a facility with a skilled attendant to prevent and manage

PPH and other complications at delivery. However, there continue to be barriers for both women and

women from receiving a uterotonic drug at delivery. In settings such as Tanzania,

especially in the project districts (Kigoma Urban, Kilombero, Rufiji and Ulanga) where over half (53%) of

additional strategies to reach women with life-saving interventions such

. More than 90% of women receive ANC from a health professional at least

(NBS Tanzania and ORC Macro, 2005). These visits provide an important

opportunity to distribute misoprostol and enable those who cannot reach a facility at the time of

saving technology.

demonstrates that women are capable of retaining inform

for PPH prevention at home births after distribution by a community

education on proper use (Rajbhandari et al., 2010; Sanghvi et al., 2010).

misoprostol is distributed for use at home births, a higher proportion of women receive a uterotonic

to determine excessive bleeding warranting referral. TBAs were waiting too long to seek assistance for

omen experiencing PPH at home births, putting them at increased risk of maternal death. Use of a common

household item as a standard measure for blood loss provides an opportunity to educate TBAs and women

Measurement of blood loss through simple observation is inaccurate, even in clinical settings. The kanga

provides a reliable and effective method of diagnosing PPH at home deliveries. If similar cloth items of standard

cloth in Zambia), they should be utilized as a

postpartum blood loss measurement tool, and women and TBAs should be counseled to know the threshold of

T ANC FOR PREVENTION OF PPH AT

All women should be encouraged to deliver at a facility with a skilled attendant to prevent and manage

e barriers for both women and

n settings such as Tanzania,

, Kilombero, Rufiji and Ulanga) where over half (53%) of

saving interventions such

from a health professional at least

ovide an important

at the time of

that women are capable of retaining information and safely

at home births after distribution by a community

2010). When

of women receive a uterotonic

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4

drug for prevention of PPH, especially women of lower economic status and those who cannot reach a

facility to deliver (Rajbhandari et al., 2010). Safety is not compromised by including community health

workers in misoprostol distribution; indeed the incidence of adverse events is often found to be higher

in areas where misoprostol is not available due to the use of traditional medicines and herbs. Moreover,

in Afghanistan, births attended by skilled providers were higher in areas where misoprostol was made

available directly to women, likely as a result of community health workers reinforcing messages about

the importance of delivering in a facility (Sanghvi et al., 2010).

As a high proportion of women in Tanzania attend at least one ANC visit, this is an ideal contact point for

reaching as many pregnant women as possible with messages about safe delivery, risks of PPH, and the

use of misoprostol.

2. Project Description

2.1 PROJECT GOALS AND OBJECTIVES

The goal of this project was to save mothers’ lives by increasing the number of women protected from

postpartum hemorrhage with a uterotonic drug, particularly at home births. In conjunction with a

community awareness campaign on birth preparedness and PPH prevention, this project distributed

misoprostol tablets at ANC visits to pregnant women to prevent PPH in the event that they are unable to

reach a facility to deliver.

The project’s main objective was to demonstrate safety, acceptability, feasibility and program

effectiveness of misoprostol distribution to pregnant women through ANC visits. More specifically, this

project aimed to:

• Demonstrate that the ANC visit is a feasible and effective means of distributing misoprostol for

PPH prevention to women who cannot get to a facility to deliver and consequently, give birth at

home.

• Provide necessary evidence that women can safely self-administer misoprostol for prevention of

PPH at home births after receiving the drug at ANC visits and being educated on its use.

• Determine if women find misoprostol to be an acceptable means of preventing PPH at home

births.

Evidence generated from this project will inform Tanzania’s policy decision-makers on the use of

misoprostol at home births, dispensed during ANC visits. Results from this project will inform the

development of a model that can be applied throughout Tanzania and other countries, especially in

settings where most women deliver without a skilled attendant.

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2.2 LOCATION

The project was conducted in four districts in Tanzania

totaling around one million in population: Kigoma

Urban, Kilombero, Ulanga and Rufiji. Kigoma is located

on northwestern Tanzania bordering Lake Tanganyika.

Kilombero, Ulanga, and Rufiji are located in

southeastern Tanzania.

All facilities in these four districts that provide ANC

participated in the project. Facilities included hospitals,

health centers and dispensaries, the lowest level of the

health care system. Table 1 specifies the population,

ANC coverage and resources in each of the project

areas.

Table 1: Population, estimated births, ANC coverage and ANC resources in project districts

Sites Population Estimated

Births/Year

ANC Coverage # ANC

sites

# ANC

providers

Kigoma Urban 168,112 6,725 91% 14 34

Kilombero 399,600 3,675 98% 44 93

Ulanga 212,597 5,527 87% 33 64

Rufiji 226,928 4,312 98% 52 102

Total 1,007,237 20,239 -- 143 293

2.3 PROJECT TIMELINE

The project took place over the course of three years. In early 2008, the partners began working on the

project protocol for submission to the Institutional Review Board, developing the community awareness

campaign materials, and drafting the manual of operations and data collection tools. Training of project

personnel took place in November and December 2008 (see 3.3 Project Personnel and Training).

Implementation of the project began in mid-January 2009 and continued through mid-January 2010. In

January 2010, the researchers shared the results of a preliminary analysis of the data with project

partners and stakeholders. Follow-up of participants continued through mid-2010, with data

management, analysis and report-writing occurring in the second half of the year.

Figure 1: Project timeline

• Development

• Training2008 Implementation2009• Stakeholders’

meeting (Jan)

• Follow-up

• Analysis

2010

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2.4 ETHICAL REVIEW

Institutional Review Board approval for this project was obtained from the University of California,

Berkeley and the National Institute for Medical Research and MOHSW, Tanzania.

3. Methods

3.1 STRATEGY AND DESIGN

This operations research was comprised of two components:

1. Community awareness campaign on birth preparedness and PPH prevention: Using various

communication vehicles, the campaign aimed to create awareness about the consequences of

PPH, the importance of delivering in a health facility, blood loss measurement with the kanga,

and the use of misoprostol for the prevention of PPH. The awareness campaign focused on the

importance of ANC visits throughout pregnancy and that after 32 weeks gestation eligible

women would receive misoprostol at ANC visits. The campaign utilized radio messaging, printed

materials and one-on-one interaction to communicate the main messages of the campaign, with

primary emphasis on the project’s tagline, “Plan early for a safe delivery.”

2. Focused ANC with misoprostol distribution: Education provided at ANC visits was a cornerstone

of this project and ANC served as the entry point for enrollment and distribution of misoprostol

tablets to pregnant women. During routine ANC care, providers conducted an Education

Session with all women on safe delivery and PPH prevention, including information on

misoprostol. During the following one-on-one sessions, providers asked women if they would

like to participate in the project; enrolled assenting women by asking them to sign the informed

consent form if they were aged 18 or older; provided further information on the use of

misoprostol for the prevention of PPH; screened women for eligibility to take misoprostol home;

and dispensed misoprostol tablets to women with 32 weeks or more gestation for use at home

births in the event they could not deliver in a health facility. Women were not eligible to receive

misoprostol if they were less than 32 weeks gestation, had bronchial asthma or another chronic

disease, or the providers anticipated a complicated delivery. Women could enroll in the project

at any point during their pregnancy, but only received misoprostol when they had reached 32

weeks gestation. Enrolled women were also asked if they would subsequently participate in a

postpartum interview, either at the health facility or at home, to provide the researchers with

information about their delivery experience and knowledge and use of misoprostol.

3.2 INFORMATION, EDUCATION AND COMMUNICATION CAMPAIGN COMPONENTS

In conjunction with the education that women received at ANC visits, an extensive information,

education and community awareness campaign on birth preparedness and PPH prevention was ongoing

in project areas (as noted above) to bolster safe delivery messages, and reinforce the importance of

delivering in a facility and women’s knowledge of misoprostol for PPH in the project communities.

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The community awareness campaign included

1. Importance of delivering at a health facility

2. Birth preparedness and planning early for a safe delivery

3. PPH consequences, and recognition using the

4. Misoprostol for the prevention of PPH, which is available at ANC

have reached 32 weeks gestation

Two radio scripts of 30 seconds in length were recorded in

Tanzania Broadcasting Corporation (

that broadcasts from Ifakara town and covers K

of the project, seven radio spots were aired per day. TBC has national coverage, and for the purposes of

this campaign, targeted Kigoma Urban

that were not covered by Pambazuko.

totaling 60 radio spots. In the second and third months, two radio spots aired every two days;

radio spots were aired per month in the second and third months.

IHI, VSI and the MOHSW collaboratively created the

materials for both clinic- and community

Printed materials included informational posters to hang in

clinics and pamphlets for clients to take home with

both of which display pictorial instructions on how to use

misoprostol for prevention of PPH.

two thousand informational posters

evenly among the districts. In addition, 20,000 prints of

the pamphlets were produced and distributed to the

districts in proportion to their respective population size

(Kigoma Urban = 4,000; Rufiji = 6,000; Kilombero = 5,000;

Ulanga = 5,000). A community awareness

developed and 8,000 copies were produced and

distributed equally among the districts.

All women coming to ANC in the project districts

provided an Education Session on birth preparedness and

PPH prevention that included information on the four

main messages of the awareness campaign. To increase

community-level awareness on birth preparedness, PPH

and misoprostol, community resource persons (

and TBAs also conducted awareness meetings with

community leaders and women’s groups in their geographic

information sessions with pregnant women in their villages.

conducting one-on-one educational

posters in prominent locations in the community (e.g. market, well, etc)

7

nity awareness campaign included four key messages:

Importance of delivering at a health facility;

Birth preparedness and planning early for a safe delivery;

PPH consequences, and recognition using the kanga method; and

Misoprostol for the prevention of PPH, which is available at ANC clinics once pregnant women

have reached 32 weeks gestation.

Two radio scripts of 30 seconds in length were recorded in Kiswahili and aired on Pambazuko and

Tanzania Broadcasting Corporation (TBC) FM radio stations. Pambazuko radio is a local FM radio stat

that broadcasts from Ifakara town and covers Kilombero and Ulanga districts. For the first three months

of the project, seven radio spots were aired per day. TBC has national coverage, and for the purposes of

Urban and Rufiji districts, and also covered some areas of Ulanga district

were not covered by Pambazuko. During the first month, two radio spots aired per day on

In the second and third months, two radio spots aired every two days;

radio spots were aired per month in the second and third months.

ollaboratively created the

and community-level education.

informational posters to hang in

to take home with them,

both of which display pictorial instructions on how to use

. The IHI staff printed

sters and distributed them

the districts. In addition, 20,000 prints of

the pamphlets were produced and distributed to the

districts in proportion to their respective population size

= 4,000; Rufiji = 6,000; Kilombero = 5,000;

community awareness poster was also

000 copies were produced and

the districts.

All women coming to ANC in the project districts were

provided an Education Session on birth preparedness and

information on the four

main messages of the awareness campaign. To increase

level awareness on birth preparedness, PPH

community resource persons (CORPs)

awareness meetings with

ommunity leaders and women’s groups in their geographic coverage areas, and conduct

gnant women in their villages. CORPs and TBAs used the

educational sessions with pregnant women, and hung community awareness

posters in prominent locations in the community (e.g. market, well, etc).

Figure 2: Community awareness poster

clinics once pregnant women

Pambazuko and

Pambazuko radio is a local FM radio station

For the first three months

of the project, seven radio spots were aired per day. TBC has national coverage, and for the purposes of

, and also covered some areas of Ulanga district

During the first month, two radio spots aired per day on TBC,

In the second and third months, two radio spots aired every two days; thus, 22

areas, and conducted one-on-one

CORPs and TBAs used the pamphlets when

, and hung community awareness

: Community awareness poster

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8

Figure 3: Organizational structure of the project

(including one of four districts)

3.3 PROJECT PERSONNEL AND TRAINING

3.3.1 Organizational Structure

Dr. Godfrey Mbaruku, Director of the Empower Project at the Ifakara Health Institute (IHI), and Dr.

Ndola Prata, Associate Professor in Residence at UCB School of Public Health, Scientific Director of the

UCB Bixby Center, and Director, Medical and Programs of VSI, were the lead investigators of this project.

Staff at both IHI and VSI assisted in the development, coordination, and organization of project training,

implementation, and data collection and management. IHI oversaw the implementation of this

operations research project,

including ongoing monitoring of

activities and data management.

VSI provided financial and

technical support to the project,

including the development of data

collection tools, training materials,

monitoring and evaluation (M&E)

design, and data analysis

management. With VSI, the Bixby

Center at UCB provided technical

assistance to this project.

Each district had a district

coordinator who oversaw ANC

providers, research assistants, and

CORPs and TBA supervisors, who in

turn managed the CORPs and TBAs

working in each district (Figure 3).

3.3.2 Training Structure

In November 2008, IHI and VSI led a five-day master training on project protocols for district teams,

district coordinators and research assistants. Following the master training, each district held trainings

for ANC providers led by the district coordinator and members of the project management (program

manager, data manager, personal digital assistant (PDA) expert and senior researchers). In addition,

each district held trainings for TBA and CORPs supervisors, and TBA and CORPs outreach workers on the

community awareness campaign. All project staff were trained by mid-January 2009, totaling 293 ANC

providers, 37 Research Assistants, 165 CORPs, 23 CORPs supervisors, 150 TBAs and 18 TBA supervisors.

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3.4 DATA MANAGEMENT AND ANALYSIS

3.4.1 Data Collection Tools

Using the Misoprostol Addendum to the ANC Card (“ANC Addendum”), ANC providers collected

information on every project participant during her first visit and at subsequent visits, including ANC

information, enrollment status, and whether or not she had received misoprostol tablets. During

enrollment, ANC providers asked enrolled women for their consent to participate in a follow-up

postpartum interview. The Postpartum Interview Questionnaire collected participants’ views of and

experience with misoprostol, knowledge about PPH and misoprostol, and delivery experience. The

postpartum interview was conducted before discharge if a participant delivered at a health facility,

when the participant returned to the health facility for postnatal care, or through active follow-up.

Therefore, women participating in the postpartum interview could have delivered at home or at a health

facility, and could have used misoprostol or received oxytocin at delivery or not.

3.4.2 Data Entry and Management

Entry of project data collection forms occurred throughout the project, conducted by research assistants

using PDAs. Research assistants met with their respective district coordinator on a regular basis to

upload their inputted data, and the district coordinator transferred district databases to the data

manager at IHI on a monthly basis. The IHI Data Manager and the VSI M&E Coordinator jointly

conducted review and management of the data.

3.4.3 Data Analysis

All analyses were conducted in Stata/SE 10 (StataCorp 2007) by the VSI M&E Coordinator in December

2010. Results were summarized using frequency tables and cross-tabulations. Differences between

groups were assessed using a criterion of p<0.05 to assess statistical significance.

4. Results

Enrollment in the project began in mid-January 2009 and continued until mid-January 2010. Of the

women who attended ANC, the researchers anticipated that 80% would agree to participate in the

project. ANC providers were successful in recruiting women into the project, achieving a 97% enrollment

rate of women coming to ANC, and thereby recruiting 12,511 women to participate in the project.

Project staff conducted postpartum interviews with approximately half (54%) of women enrolled in the

project. Of those, 1,826 used misoprostol at a home birth.

Table 2: Data for analysis

Kigoma Kilombero Rufiji Ulanga Total

ANC attendance 2,244 4,322 3,611 2,715 12,892

Number of clients enrolled in project

(% of ANC attendance)

2,206

(98.3%)

4,158

(96.2%)

3,568

(98.8%)

2,579

(95.0%)

12,511

(97.0%)

Postpartum interview

(% of enrolled)

1,280

(58.0%)

1,771

(42.6%)

1,940

(54.4%)

1,744

(67.6%)

6,735

(53.8%)

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Enrollment over the life of the project is shown in Figure 4.

Figure 4: Enrollment by month

Source: Misoprostol Addendum

4.1 CHARACTERISTICS OF THE PARTICIPANTS

The background characteristics of the participants are presented in Table 3 based on data collected from

the Misoprostol Addendum. Most women were in their mid-twenties (mean age 26.4 years) and had at

least some primary-level education (66%). Most women had some form of employment; however this

varied by district. While agriculture was the predominant occupation of women in Kilombero, Rufiji and

Ulanga (87 to 95%), fewer than half the women in Kigoma Urban stated working in agriculture (46%);

they mentioned business (18%) and housework (21%) as their occupation much more frequently than

women in the other districts. Fertility was high amongst the participants, with 42% reporting having four

or more live births.

-

2,000

4,000

6,000

8,000

10,000

12,000

12,511

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11

3.53.3

2.9

2.5

3.0

0

1

2

3

4

Kigoma Kilombero Rufiji Ulanga Overall

Av

era

ge

nu

mb

er

of

AN

C v

isit

s

Table 3: Background characteristics of the participants

Kigoma Kilombero Rufiji Ulanga Total

Total enrolled 2,206 4,158 3,568 2,579 12,511

Mean age (years)ˆ(min; max) 26.0 (18;46) 26.2 (18;50) 27.1 (18;52) 26.3 (18;52) 26.4 (18;52)

Education

No education 328 (14.9%) 821 (19.8%) 1,740 (48.8%) 890 (34.5%) 3,779 (30.2%)

Primary 1,673 (75.8%) 3,193 (76.8%) 1,748 (49.0%) 1,642 (63.7%) 8,256 (66.0%)

Secondary and above 205 (9.3%) 144 (3.5%) 80 (2.2%) 47 (1.8%) 476 (3.8%)

Occupationˆˆ

Business1

392 (17.8%) 128 (3.1%) 49 (1.4%) 28 (1.1%) 597 (4.8%)

Agriculture2

1,019 (46.2%) 3,620 (87.1%) 3,362 (94.2%) 2,448 (94.9%) 10,449 (83.5%)

Other3

254 (11.5%) 124 (3.0%) 110 (3.1%) 29 (1.1%) 517 (4.1%)

Unemployed4

539 (24.4%) 252 (6.1%) 43 (1.2%) 60 (2.3%) 894 (7.2%)

Gravidaˆˆˆ

1 429 (19.5%) 787 (18.9%) 405 (11.4%) 366 (14.2%) 1,987 (15.9%)

2 482 (21.9%) 982 (23.6%) 714 (20.0%) 511 (19.7%) 2,686 (21.5%)

3 388 (17.6%) 879 (21.1%) 686 (19.2%) 512 (19.9%) 2,465 (19.7%)

> 4 898 (40.7%) 1,459 (35.1%) 1,753 (49.1%) 1,174 (45.5%) 5,284 (42.2%)

Source: Misoprostol Addendum

ˆNo information for 0.6% of women

ˆˆ No information for 0.4% of women

ˆˆˆNo information for 0.7% of women 1 Includes trade, commerce, office work (clerk), service (seamstress, hair plaiting, etc.)

2 Includes farming and fishing

3 Includes student, day laborer and mineral extraction

4 Includes housework

On average, women reported attending three ANC visits during the course of their most recent

pregnancy in the postpartum interview (Figure 5). Some variation between the districts was observed,

with women in Rufiji reporting an average of two and half ANC visits and women in Kigoma Urban

reporting an average of three and a half ANC visits.

Figure 5: Average number of ANC visits by district

Source: Postpartum Interview

ˆNo information for 1.7% women

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Place and attendant at delivery of the women who participated in the postpartum interview are

presented in Table 4. In this sample, two thirds of women delivered in a health facility (69%), which is

higher than the national average of 47% in the Demographic and Health Survey (NBS Tanzania and ORC

Macro, 2005). There was some variation in the rate of health facility delivery between districts, with

Rufiji reporting the lowest rate of facility births (57%) and Kilombero reporting the highest (79%).

Correspondingly, approximately two thirds of women in the sample delivered with a skilled provider,

most often a nurse-midwife (53%). However, there is a missing response on attendant at delivery for a

third of participants, most of whom delivered either at home or on the way to the health facility, where

it is presumed they delivered without a trained provider (e.g. TBA, friend, relative or alone).

Table 4: Delivery characteristics

Kigoma

(n=1,280)

Kilombero

(n=1,771)

Rufiji

(n=1,940)

Ulanga

(n=1,744)

Total

(n=6,735)

Location of deliveryˆ

Home1

366 (28.6%) 368 (20.8%) 808 (41.7%) 533 (30.6%) 2,075 (30.8%)

Health facility 910 (71.1%) 1,399 (79.0%) 1,109 (57.2%) 1,207 (69.2%) 4,625 (68.7%)

Attendant at delivery

Doctor 374 (29.2%) 71 (4.0%) 95 (4.9%) 39 (2.2%) 579 (8.6%)

Assistant Medical

Officer/Clinical Officer 111 (8.7%) 88 (5.0%) 66 (3.4%) 101 (5.8%) 366 (5.4%)

Midwife 388 (30.3%) 1,199 (67.7%) 932 (48.0%) 1,055 (60.5%) 3,574 (53.1%)

TBA 14 (1.1%) 6 (0.3%) 4 (0.2%) 3 (0.2%) 27 (0.4%)

Friend/relative 3 (0.2%) 0 1 (0.1%) 0 4 (0.1%)

No data2

390 (30.5%) 407 (23.0%) 842 (43.4%) 546 (31.3%) 2,185 (32.4%)

Source: Postpartum Interview 1 Includes 133 who delivered on the way to the health facility (2.0%)

2 No information on attendant at delivery

ˆ No information for 0.5% of women

4.2 COMMUNITY AWARENESS CAMPAIGN COVERAGE AND COMPREHENSION OF

MESSAGES

As mentioned above, the project included a community awareness campaign, utilizing radio, print and

one-on-one communication (ANC education sessions and community awareness activities of CORPs and

TBAs) to reach women with safe delivery messages. In the postpartum interview, participants were

asked if they had received information on PPH and misoprostol, and the sources from which they

learned this information. Their responses are presented in Table 5.

The campaign was effective in reaching women, with 96% of respondents stating that they had received

information on PPH. Women were asked to list all sources of PPH information they received. Of note,

health providers and facilities were the most frequently cited sources of information about bleeding

after childbirth (97%). Posters/pamphlets (34%), radio (22%), community health worker (21%),

friend/relative (16%) and TBA (15%) were mentioned less frequently as sources of information about

PPH.

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Table 5: Women's report of receiving information on PPH

Kigoma

(n=1,280)

Kilombero

(n=1,771)

Rufiji

(n=1,940)

Ulanga

(n=1,744)

Total

(n=6,735)

Reported receiving information

about bleeding after childbirth 1,128 (88.1%) 1,732 (97.8%) 1,853 (95.5%) 1,729 (99.1%) 6,442 (95.7%)

Reported sources of information on bleeding after childbirth

Midwife/health facility 1,076 (95.4%) 1,679 (96.9%) 1,783 (95.2%) 1,696 (98.1%) 6,234 (96.8%)

Community health

worker/CORPs 102 (9.0%) 277 (16.0%) 538 (29.0%) 431 (24.9%) 1,348 (20.9%)

TBA 67 (5.9%) 134 (7.7%) 602 (32.5%) 169 (9.8%) 972 (15.1%)

Friend/relative 120 (10.6%) 155 (9.0%) 351 (18.9%) 382 (22.1%) 1,008 (15.6%)

Radio 33 (2.9%) 814 (47.0%) 95 (5.1%) 445 (25.7%) 1,387 (21.5%)

Posters/pamphlets 162 (14.4%) 621 (35.9%) 785 (42.3%) 599 (34.7%) 2,167 (33.6%)

Source: Postpartum Interview

In addition to the information they received on PPH, almost all participants received information about

misoprostol (99% of respondents) (Table 6). Almost all respondents received misoprostol information

from a midwife and/or health facility (98%). Other reported sources of misoprostol information were

similar to those mentioned as sources of information on PPH. There was some variation across districts

in reach of the different communication vehicles. More participants reported learning about PPH and

misoprostol from the radio in Kilombero and Ulanga (39% and 27%, respectively vs. 3% in Kigoma Urban

and Rufiji). TBAs played a minor role in reaching women with the campaign messages in all districts

except Rufiji (32% vs. less than 10% in the other districts). Posters and pamphlets were reported much

less often in Kigoma Urban (16% vs. 35% to 47% in the other districts), most likely due to the fact that

this district did not receive clinic or community posters until later in the project timeline.

Table 6: Women's report of receiving information on misoprostol

Kigoma

(n=1,280)

Kilombero

(n=1,771)

Rufiji

(n=1,940)

Ulanga

(n=1,744)

Total

(n=6,735)

Reported receiving information

about misoprostol 1,269 (99.1%) 1,745 (98.5%) 1,914 (98.7%) 1,725 (98.9%) 6,653 (98.8%)

Reported sources of information about misoprostol

Midwife/health facility 1,219 (96.1%) 1,703 (97.6%) 1,867 (97.5%) 1,710 (99.1%) 6,499 (97.7%)

Community health worker/CORPs 254 (20.0%) 322 (18.5%) 564 (29.5%) 564 (29.5%) 1,525 (22.9%)

TBA 90 (7.1%) 150 (8.6%) 612 (32.0%) 120 (7.0%) 982 (14.6%)

Drug vendor/pharmacist 3 (0.2%) 15 (0.9%) 11 (0.6%) 162 (9.4%) 191 (2.9%)

Friend/relative 135 (10.6%) 218 (12.5%) 328 (17.1%) 438 (25.4%) 1,119 (16.8%)

Radio 34 (2.7%) 685 (39.3%) 59 (3.1%) 462 (26.7%) 1,240 (18.6%)

Posters/pamphlets 200 (15.8%) 610 (34.5%) 894 (46.7%) 597 (34.6%) 2,301 (34.6%)

Source: Postpartum Interview

As seen in Figure 6, a midwife and/or health facility was mentioned as the most important source of

information on misoprostol across the four districts (85% to 94%), with the other sources listed in very

small numbers. In Kigoma Urban, community health workers played an important role in the

dissemination of misoprostol information that was not as profound in other districts (13% vs. 1 to 4% in

other districts).

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85%

91% 93% 94% 91%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Kigoma Kilombero Rufiji Ulanga Total

Posters/Pamphlets

Friend/Relative

Community Health Worker

Midwife/Health Facility

TBA

Radio

Figure 6: Most important source of information on misoprostol by district

Source: Postpartum Interview

No information for 0.1% of women

Radio <1% of women in Rufiji and Kigoma (not shown)

TBA <1% of women in Kigoma & Ulanga (not shown)

Drug vendor/pharmacist <1% of women in Kilombero, Rufiji, and Ulanga; 0% of women in Kigoma (not shown)

Overall, recall of the community awareness campaign messages was high amongst participants in the

postpartum interview sample (Table 7). When asked during the postpartum interview what information

they received about excessive bleeding, most respondents spontaneously said that it can cause death

(89%) and recognized that excessive bleeding occurs when two or more kangas are soaked with blood

(84%).

The community awareness campaign, in particular the facility-based education sessions, was highly

effective in educating women about misoprostol, as knowledge of the key misoprostol messages was

very high amongst respondents. Almost all respondents in the postpartum interview knew the function

(98%), correct timing (98%), correct dose (98%) and correct route (98%) of misoprostol for PPH

prevention. Additionally, 75% of participants knew of at least one symptom of misoprostol use, with

shivering (68%) and nausea (64%) noted most frequently.

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Table 7: Women's spontaneous response on information received on excessive bleeding and

misoprostol

Kigoma

(n=1,280)

Kilombero

(n=1,771)

Rufiji

(n=1,940)

Ulanga

(n=1,744)

Total

(n=6,735)

What information do you know about excessive bleeding?

Can cause death 1,093

(85.4%)

1,517

(85.7%)

1,726

(89.0%)

1,633

(93.6%)

5,969

(88.6%)

Go to a health facility promptly 231

(18.1%)

980

(55.3%)

983

(50.7%)

1,040

(59.6%)

3,234

(48.0%)

Bleeding soaks two kangas or more 1,032

(80.6%)

1,443

(81.5%)

1,633

(84.2%)

1,523

(87.3%)

5,631

(83.6%)

What information do you know about misoprostol?

Misoprostol prevents, stops or reduces

the chances of bleeding after childbirth

1,269

(99.1%)

1,729

(97.6%)

1,910

(98.5%)

1,716

(98.4%)

6,624

(98.4%)

Take immediately after baby is born

(Correct timing)

1,263

(98.7%)

1,716

(96.9%)

1,906

(98.3%)

1,717

(98.5%)

6,602

(98.0%)

Take three tablets

(Correct dose)

1,266

(98.9%)

1,727

(97.5%)

1,912

(98.6%)

1,720

(98.6%)

6,625

(98.4%)

Take by swallowing

(Correct route)

1,258

(98.3%)

1,727

(97.5%)

1,913

(98.6%)

1,720

(98.6%)

6,618

(98.3%)

Mentioned any potential symptoms of

misoprostol use

1,021

(79.8%)

1,339

(75.6%)

1,259

(64.9%)

1,452

(83.3%)

5,071

(75.3%)

Mentioned shivering 1,006

(78.6%)

1,215

(68.6%)

1,109

(57.2%)

1,215

(69.7%)

4,545

(67.5%)

Mentioned nausea 975

(76.2%)

1,164

(65.7%)

1,046

(53.9%)

1,150

(65.9%)

4,335

(64.4%)

Mentioned vomiting 880

(68.8%)

1,004

(56.7%)

942

(48.6%)

978

(56.1%)

3,804

(56.5%)

Mentioned diarrhea 415

(32.4%)

740

(41.8%)

790

(40.7%)

761

(43.6%)

2,706

(40.2%)

Mentioned increase in body

temperature

69

(5.4%)

398

(22.5%)

559

(28.8%)

451

(25.9%)

1,477

(21.9%)

Source: Postpartum Interview

4.3 FEASIBILITY: COVERAGE OF MISOPROSTOL DISTRIBUTION

ANC providers were quite effective in recruiting women into the project, enrolling 97% of women who

came to ANC into the project (Table 8). It is important to note that all women received the education

session on PPH and misoprostol, regardless of gestational age.

While we anticipated that all women would return for an ANC visit at least once after they reached 32

weeks gestation (i.e. when they became eligible to receive misoprostol), we see in Table 8 that this was

true of only 44% of enrolled participants. There was wide variation between districts, ranging from 38%

in Ulanga to 59% in Kigoma Urban.

Of women who returned after 32 weeks, almost all (97%) took misoprostol home with them. Most

women who were not given the tablets were ineligible to receive misoprostol due to other exclusion

criteria1 (2.5% of women who returned after 32 weeks).

1 Bronchial asthma or other chronic disease, expected to undergo cesarean section, and/or high risk pregnancy.

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According to the Misoprostol Addendum, fewer than 3% of women who received misoprostol were

between 28 and 32 weeks gestation, which is not in compliance with project protocol.

Table 8: Coverage of misoprostol distribution to enrolled clients at ANC visits

Kigoma Kilombero Rufiji Ulanga Total

ANC attendance 2,244 4,322 3,611 2,715 12,892

Number of clients enrolled in project

(% of ANC attendance)

2,206

(98.3%)

4,158

(96.2%)

3,568

(98.8%)

2,579

(95.0%)

12,511

(97.0%)

Attended ANC at > 32 weeks gestation

(of enrolled women eligible for

misoprostol distribution)ˆ

1,297

(58.8%)

1,708

(41.1%)

1,535

(43.0%)

967

(37.5%)

5,507

(44.0%)

Took misoprostol home from ANC

(of enrolled women eligible for

misoprostol distribution)

1,294

(99.8%)

1,669

(97.7%)

1,492

(97.2%)

877

(90.1%)

5,332

(96.8%)

Source: Misoprostol Addendum

ˆNo information for 0.2% of women

4.4 PROGRAM EFFECTIVENESS: COVERAGE OF MISOPROSTOL AT HOME BIRTHS AND

BIRTHS PROTECTED FROM PPH

Use of misoprostol for PPH prevention at home is a key indicator of program effectiveness. Of the 2,075

home deliveries reported amongst the postpartum interview respondents, 88% used misoprostol

received during an ANC visit. Of the women who delivered at home but did not use a uterotonic at the

time of birth, 68 (28%) received misoprostol from ANC and did not use it at delivery (reasons for not

using described in Section 4.6) (data not shown). It can be assumed that the remaining women who did

not receive a uterotonic at home delivery did not receive misoprostol from ANC because of eligibility

requirements (e.g. gestational age).

Table 9: Reported uterotonic use at deliveryˆ

Kigoma

(n=1,280)

Kilombero

(n=1,771)

Rufiji

(n=1,940)

Ulanga

(n=1,744)

Total

(n=6,735)

Home birth1 366 368 808 533 2,075

Injection 0 2 (0.5%) 0 1 (0.2%) 3 (0.1%)

Misoprostol 345 (94.3%) 319 (86.7%) 708 (87.6%) 454 (85.2%) 1,826 (88.0%)

No uterotonic 21 (5.7%) 47 (12.8%) 100 (12.4%) 78 (14.6%) 246 (11.9%)

Facility birth 910 1,399 1,109 1,207 4,625

Misoprostol 297 (32.6%) 380 (27.2%) 105 (9.5%) 762 (63.1%) 1,544 (33.4%)

Injection 566 (62.2%) 883 (63.1%) 917 (82.7%) 365 (30.2%) 2,731 (59.1%)

No uterotonic 47 (5.2%) 136 (9.7%) 87 (7.8%) 80 (6.6%) 350 (7.6%)

Source: Postpartum Interview 1Includes births en route to the health facility

ˆ35 (0.5%) women were missing information on location of delivery

Overall, coverage of deliveries with a uterotonic drug for PPH prevention after delivery and proportion

of births protected against PPH (“protected births”) are important indicators that the project achieved

its objectives. A protected birth for the purposes of this analysis is a delivery where the mother is

protected from PPH by use of any uterotonic administered or taken for PPH prevention. Overall

coverage of deliveries with a uterotonic was high among postpartum interview respondents (91%).

Among the more than 6,500 women who participated in the postpartum interview, most respondents

reported receiving an injection at a health facility (41%), misoprostol at a health facility (23%), or

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12% 8%

59%

88%

33%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Home Delivery

(n=2,075)

Facility Delivery

(n=4,625)

Misoprostol

Injection

No uterotonic

misoprostol at home (27%)(Table 10). There was some variation across districts on the uterotonic used.

Misoprostol use at a home delivery ranged from 26% in Ulanga to 37% in Rufiji. Use of injection at

delivery for PPH prevention was highest in Kilombero (50%) and lowest in Ulanga (21%). Misoprostol use

at health facilities varied greatly, from 5% in Rufiji to 44% in Ulanga.

Table 10: Births protected from PPH

Kigoma

(n=1,280)

Kilombero

(n=1,771)

Rufiji

(n=1,940)

Ulanga

(n=1,744)

Total

(n=6,735)

Uterotonic for PPH prevention

Injection 566 (44.2%) 885 (50.0%) 917 (47.3%) 366 (21.0%) 2,734 (40.6%)

Misoprostol at health facility 297 (23.2%) 380 (21.5%) 105 (5.4%) 762 (43.7%) 1,544 (22.9%)

Misoprostol at home 345 (27.0%) 319 (18.0%) 708 (36.5%) 454 (26.0%) 1,826 (27.1%)

No uterotonic 72 (5.6%) 187 (10.6%) 210 (10.8%) 162 (9.3%) 631 (9.4%)

Births protected from PPH1 1,208 (94.4%) 1,584 (89.4%) 1,730 (89.2%) 1,582 (90.7%) 6,104 (90.6%)

1Any uterotonic given for PPH prevention

Source: Postpartum Interview

Misoprostol protected an additional 27% of deliveries that occurred at home, deliveries that would not

have been protected from PPH were it not for misoprostol distribution at ANC. Based on a previous

study conducted in Kigoma (Prata et al., 2005), the incidence rate for PPH (bleeding of 500mL or more)

is estimated to be around 20%. Using this as a measure, we estimate that of the 4,001 women who did

not receive an injection to prevent PPH, around 800 women would develop bleeding after delivery

necessitating referral and/or additional interventions to stop the bleeding.

As seen in Figure 7, protected births at home were high at 88%. This demonstrates the program’s

effectiveness and impact; without misoprostol these women would have been unprotected from PPH.

Figure 7: Coverage of protected births at home vs. health facility deliveries

Source: Postpartum Interview

No information for 0.5% of women

p<0.01

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4.5 PROGRAM EFFECTIVENESS: BLEEDING-RELATED REFERRALS AND NEED FOR

ADDITIONAL INTERVENTIONS

A bleeding-related referral includes both excessive bleeding and retained placenta, and was determined

based on the participant’s self-report in the postpartum interview. Overall, bleeding-related referrals

were low amongst women who participated in the postpartum interview; only 30 women reported

requiring referral for bleeding-related causes (<1%). Of those referred, fewer than half reported

receiving interventions at the health facility, mostly intravenous fluids, manual removal of placenta, and

injection.

Nine women indicated that they were referred during labor and delivery but did not go to a health

facility. Reasons given for not going to the health facility included no transportation, too expensive, did

not want to go to a health facility, partner was not present, and could not make a decision. Each of these

reasons was reported by at least one woman.

Table 11: Referrals and additional interventions

Kigoma

(n=1,280)

Kilombero

(n=1,771)

Rufiji

(n=1,940)

Ulanga

(n=1,744)

Total

(n=6,735)

Referral during labor and deliveryˆ 9 (0.7%) 80 (4.5%) 39 (2.0%) 49 (2.8%) 177 (2.6%)

Prolonged labor 1 20 13 9 43

Excessive bleeding 0 2 9 2 13

Retained placenta 5 3 4 5 17

Other 1 30 11 24 66

No information 2 25 2 9 38

Received interventions

(of those referred)

7 (77.8%) 36 (45.0%) 20 (51.3%) 14 (28.6%) 77 (43.5%)

Blood transfusion 1 0 4 7 12

Intravenous fluids 2 12 12 7 33

Injection 1 23 8 1 33

Manual removal of placenta 5 22 4 3 34

Major surgery 0 8 4 6 18

Repair of tears 0 2 0 3 5

None 0 2 1 3 6

Source: Postpartum Interview

ˆNo information for 0.5% of women

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25%

10%

16%

39%

3% 7% Car^

Public transportation

Walking

Bicycle

Other

No information

Most of the women who were referred traveled to the health facility via bicycle (39%), either a personal

or borrowed car (25%), walking (16%), or public transportation (10%).

Figure 8: Mode of transportation to the health facility of those referred

Source: Postpartum Interview

^Includes personal car, car borrowed from a friend/relative/neighbor, and health care provider’s car

4.6 PROGRAM EFFECTIVENESS: UTEROTONIC COVERAGE AND NEED FOR ADDITIONAL

INTERVENTIONS AT HOME BIRTHS

Most of the women delivered at a health facility regardless of if they received misoprostol at ANC; 82%

of women who took misoprostol home from ANC delivered at a health facility compared to 86% of

women who did not receive misoprostol at ANC. Women delivering at health facilities generally received

a uterotonic at delivery (92% received an injection or misoprostol; data not shown).

Of the 68 women who took misoprostol home from ANC but did not use it at delivery, reasons for not

using the drug included: not having it or not being able to find the tablets (n=12); TBA, husband, family

member not wanting her to take it (n=6); TBA giving traditional medicine (n=4); believing misoprostol

would not work (n=4); fear of side effects (n=3); not thinking she would need it (n=1); not having

information about it (n=1); and not knowing how to take it (n=1).

Figure 9 presents misoprostol distribution during ANC, uterotonic at delivery, and the need for

additional interventions amongst postpartum interview respondents who delivered at home.

Of those who took misoprostol home from ANC and delivered at home, most used misoprostol at

delivery (96%). Only eleven women who took misoprostol at a home birth needed additional

interventions (<1%): four received intravenous fluids, two received an injection, and five received

manual removal of placenta (some women received more than one intervention).

Virtually all of the women who did not take misoprostol home from ANC and who delivered at home

received no uterotonic at delivery. Consequently, a higher percentage of these women needed

additional interventions than those who delivered at home and used misoprostol (6% vs. <1%

respectively). Additionally, more interventions were needed for these women – four received a blood

transfusion, three received intravenous fluids, eight received injection, and one received manual

removal of placenta.

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Postpartum interview

(n=6,735)

Took misoprostol home from ANC

(n= 4,089)

Home birth

(n=1,895)

Uterotonic at delivery

(n=1,827; 96%)

Additional interventions

(n=11; <1%)

No uterotonic at delivery

(n=68; 4%)

Additional interventions

(n=3; 4%)

Did not take misoprostol home

(n=1,476)

Home birth

(n=180)

Uterotonic at delivery

(n=2; 1%)

Additional interventions

(n=0)

No uterotonic at delivery

(n=178; 99%)

Additional interventions

(n=10; 6%)

Women who delivered at home and did not use misoprostol had almost nine times higher risk for

additional interventions (than women who delivered at home and used misoprostol (risk ratio 8.8; 95%

CI 4.0-19.4; p<0.01).

Figure 9: Need for additional interventions at home births with and without misoprostol

Source: Postpartum interview

4.7 SAFETY: CORRECT USE OF MISOPROSTOL AND POSTPARTUM SYMPTOMS

Of women who used misoprostol at home births, almost all reported using the correct dose and route of

misoprostol (Table 12). No woman who took misoprostol at home reported taking either a dose or using

a route different from what they had been educated to do during ANC and in the community awareness

campaign (three tablets taken orally). Therefore, correct misoprostol use was nearly universal (98%) for

all participants who used the drug at a home delivery for PPH prevention (the remaining 2% did not

respond to these questions).

Table 12: Correct use of misoprostol at home births

Kigoma

(n=345)

Kilombero

(n=319)

Rufiji

(n=708)

Ulanga

(n=454)

Total

(n=1,826)

Correct dose (three tablets)ˆ 344 (99.7%) 313 (98.1%) 706 (99.7%) 454 (100%) 1,817 (99.5%)

Correct route (oral) ˆˆ 337 (97.7%) 303 (94.5%) 707 (99.9%) 445 (98.0%) 1,792 (98.1%)

Correct use of misoprostol

(correct dose and route) ˆˆˆ

337 (97.7%) 303 (95.0%) 706 (99.7%) 445 (98.0%) 1,791 (98.1%)

Source: Postpartum Interview

ˆ No information for 0.5% of women who delivered at home and took misoprostol

ˆˆ No information for 1.9% of women who delivered at home and took misoprostol

ˆˆˆ No information for 1.9% of women who delivered at home and took misoprostol

Participants’ self-reports of symptoms experienced after delivery are presented in Table 13. Almost four

out of five women did not experience any symptoms during the postpartum period (79%). The most

common symptoms experienced were shivering (13%), nausea (5%), and elevated body temperature

(4%). Misoprostol users were significantly more likely to report experiencing these three symptoms.

Report of multiple symptoms was low (4%), and more common amongst misoprostol-users (5% of those

who reported symptoms, vs. 4% of those who did not receive a uterotonic drug). Symptoms self-

resolved within an hour for almost all participants.

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Table 13: Reported experience of postpartum symptomsˆ

None

(n=631)

Injection

(n=2,734)

Misoprostol1

(n=3,370)

Total

(n=6,735)

Did not experience postpartum symptoms 517 (81.9%) 2,343 (85.7%) 2,483 (73.7%) 5,343 (79.3%)

Experienced shivering 66 (10.5%) 195 (7.1%) 588 (17.4%) 849 (12.6%)

Experienced nausea 15 (2.4%) 82 (3.0%) 217 (6.4%) 314 (4.7%)

Experienced vomiting 13 (2.1%) 67 (2.5%) 99 (2.9%) 179 (2.7%)

Experienced increase in body temperature 21 (3.3%) 86 (3.1%) 154 (4.6%) 261 (3.9%)

Experienced more than one symptom 22 (3.5%) 75 (2.7%) 180 (5.3%) 277 (4.3%)

Source: Postpartum Interview 1 At home or facility birth

ˆ No information for 0.3% of women

4.8 ACCEPTABILITY: USER PERSPECTIVES ON MISOPROSTOL USE

All women in the postpartum interview were asked questions to assess their acceptability of

misoprostol.2 Acceptability of misoprostol was high amongst users and non-users alike. Almost all

women would recommend misoprostol to a friend (98%), use misoprostol in a subsequent pregnancy

(96%), or purchase misoprostol (95%) (Table 14). While women who used misoprostol were significantly

more likely to answer positively to the acceptability questions, the difference was quite small and in

none of the acceptability indicators did non-users respond ‘yes’ less than 90% of the time.

Table 14: Acceptability of misoprostol

Took misoprostol1

(n= 3,370)

Did not take

misoprostol2

(n= 3,365)

Total

(n= 6,735)

Would recommend misoprostol to a friend**ˆ 3,333 (98.9%) 3,245 (96.4%) 6,578 (97.7%)

Would use misoprostol in a subsequent delivery**ˆˆ 3,302 (98.0%) 3,188 (94.7%) 6,490 (96.4%)

Would purchase misoprostol**ˆˆˆ 3,221 (95.6%) 3,140 (93.3%) 6,361 (94.5%)

Average amount willing to pay for misoprostol in

Tanzania Shillings (Min; Max)**ˆˆˆˆ

1,460.8 (1-15,000) 1,752.9 (1-25,000) 1,604.5 (1-25,000)

Source: Postpartum Interview 1 At home or facility birth

2 Includes women who received injection (n= 2,734)

ˆNo information from 0.9% of women

ˆˆ No information from 1.3% of women

ˆˆˆ No information from 1.1% of women

ˆˆˆˆ No information from 5.5% of women who were willing to pay for misoprostol

** p<0.01

2 To assess acceptability of misoprostol among women, the interviewers described misoprostol to those participants who

previously stated they had little or no knowledge of the drug. They then assessed women’s willingness to use the drug for PPH

prevention in the future and to purchase the drug.

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5. Conclusions

The following conclusions can be derived from the results of the operations research:

COMMUNITY AWARENESS CAMPAIGN REACHED WOMEN WITH KEY MESSAGES

Reach of the community awareness campaign was wide – almost all postpartum interview respondents

had received information about PPH (96%) and misoprostol (99%). Health facilities and providers based

in facilities were the most cited and most important sources of information on PPH and misoprostol.

This is not surprising given that all women should have been presented with the Education Session

during ANC. However, the importance that participants placed on the health facility for this information

demonstrates the vital role health facilities and their staff play in educating women. This finding

suggests that moving forward the facility-based education sessions should continue to be a critical

component of the community awareness campaign.

Additionally, sources of information about PPH and misoprostol cited by women varied by district.

CORPs and printed materials, while mentioned less frequently than health facilities, proved to be an

important source of information amongst respondents (23% and 35%, respectively). The variation in the

different communication vehicles is important to highlight; the individual characteristics of districts

should be taken into account as scale-up strategies are designed.

The campaign successfully transferred knowledge to women: recall of campaign messages was quite

high. Many women mentioned the measurement of more than two kangas soaked with blood when

asked what they knew about PPH, in addition to knowing the function and correct route and dose of

misoprostol.

HIGH COVERAGE OF MISOPROSTOL DISTRIBUTION TO WOMEN > 32 WEEKS GESTATION

Of those who were eligible to receive misoprostol, virtually all women took misoprostol home from an

ANC visit after they reached 32 weeks gestation (97%). One challenge illuminated in these data is that

women are returning to ANC after 32 weeks at a rate that is lower than expected (44%). Therefore,

misoprostol was only distributed to 43% of participants in the project, mainly due to the gestational age

requirement.

ANC DISTRIBUTION OF MISOPROSTOL PROTECTS BIRTHS AT HOME AND IN FACILITIES

FROM PPH Of those who delivered at home, the majority of women took misoprostol received during an ANC

(88%). In addition, protected births were promisingly high: 91% of postpartum interview respondents

were protected from PPH by use of a uterotonic after delivery. Misoprostol plays a vital role in

protecting births both at home and in health facilities when other uterotonics are not available. During

monitoring visits for the project, the researchers noted that prior to the project dispensaries were not

stocked with a uterotonic for PPH prevention after delivery. Once the project began, participants began

returning to the dispensary for delivery and bringing the misoprostol that had been distributed to them

during ANC, as they had been told to do during the Education Session. Thus, availability of misoprostol

has increased uterotonic coverage at the dispensary level and a large proportion of the 23% of births

protected from PPH using misoprostol at a health facility may be a result. Lastly, through this project an

additional 27% of births were protected from PPH using misoprostol at home deliveries after being

distributed during ANC, vastly increasing the proportion of protected births in the population.

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NEAR UNIVERSAL CORRECT USE OF MISOPROSTOL AT HOME

The safety of misoprostol distributed at ANC for PPH prevention at home births was well demonstrated.

Almost all the women who used misoprostol at home delivery used the drug correctly, taking the correct

dose via the correct route. The high use rate and data on correct use of misoprostol demonstrate the

effectiveness of the project, as well as that of the awareness campaign. As noted above, knowledge of

PPH, its consequences, and the use of misoprostol was high amongst respondents. This most likely

played an important role in women choosing to use the drug after a home birth, and using it correctly.

Furthermore, experience of postpartum symptoms was quite infrequent, although more frequent

among misoprostol-users compared to those who did not use the drug. These symptoms were self-

resolving within an hour for most cases, and none required referral.

USE OF MISOPROSTOL AT HOME BIRTHS REDUCED THE NEED FOR ADDITIONAL

INTERVENTIONS Fewer women who delivered at home and used misoprostol needed additional interventions for

excessive bleeding compared to women who delivered at home and did not receive a uterotonic (<1%

vs. 6%, respectively). Furthermore, women who did not use misoprostol at home required more

interventions per woman than those who used the drug. Bleeding-related referrals were very low

overall (<1%).

WOMEN FIND MISOPROSTOL TO BE HIGHLY ACCEPTABLE

Misoprostol is very acceptable to women. Despite reported symptoms after use, almost all women

would recommend misoprostol to a friend, use it again in a subsequent delivery, or purchase

misoprostol. Therefore, it can be assumed that the symptoms related to misoprostol use are of minor

consequence compared to the perceived benefit of the drug.

6. Recommendations

Findings from this project demonstrate that distributing misoprostol during ANC visits to pregnant

women increases the likelihood that women will be protected from PPH at home deliveries, and the

availability of misoprostol in facilities can lead to increased uterotonic coverage at facility deliveries. We

recommend to policy makers and key stakeholders that distribution of misoprostol for PPH prevention

through ANC should be scaled up nation-wide in Tanzania.

ALL ANC PROVIDERS SHOULD BE TRAINED TO DISTRIBUTE MISOPROSTOL AT ANC

ANC providers were the cornerstone of this project, both in educating women about the importance of

delivery preparedness and the use of misoprostol and as the distribution point for the drug to pregnant

women. Arming ANC providers with specific, concrete messages showed a positive impact on quality of

antenatal care, facility delivery and use of misoprostol at home births. Additionally, ANC proved to be a

feasible and effective strategy for distributing misoprostol to pregnant women.

REVISE THE GESTATIONAL AGE LIMITATION TO INCREASE COVERAGE

ANC attendance after 32 weeks gestation when women became eligible to receive misoprostol was

lower than expected. While we recommend greater effort to encourage women to return to ANC after

they have reached the gestational age requirement in order to receive the drug, women’s tendency to

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not attend ANC later in pregnancy may be due to logistical factors rather than a lack of desire to return

for care.

We recommend lowering the gestational age restriction to at least the second trimester or removing it

completely to increase coverage of misoprostol distribution to pregnant women at ANC. Other

countries, such as Zambia and Kenya, have distributed misoprostol to women at their first ANC visit,

resulting in higher coverage of misoprostol distribution without compromising safety. If this were

adopted in Tanzania, marked increases in the number of women taking misoprostol home from ANC

would be possible.

SCALE UP THE COMMUNITY AWARENESS CAMPAIGN TO INCREASE KNOWLEDGE OF KEY

MESSAGES The community awareness campaign was integral to the success of the project, especially in ensuring

the correct use of misoprostol at home births and continuing to encourage women to deliver at health

facilities. In addition to training all ANC providers on the key messages of the campaign, community-

level mechanisms (such as CORPs, radio and printed materials) are also necessary to reach as many

women as possible with these important messages.

CONSIDER OTHER MECHANISMS OF MISOPROSTOL DISTRIBUTION FOR SELF-

ADMINISTRATION While distribution of misoprostol at ANC was shown to be feasible and effective in this operations

research project, additional means of reaching women with this life-saving drug should be considered.

For example, misoprostol could be included in clean delivery kits (Mama Packs) and distributed via ANC

or other community-level mechanisms to increase the number of women who can receive misoprostol

during pregnancy or at delivery. Community-level education, as mentioned above, is imperative to

ensure that women are aware of the dangers of PPH, know where to get misoprostol in case of a home

delivery, and are informed on correct use.

MISOPROSTOL SHOULD BE AVAILABLE IN ALL DELIVERY ROOMS

While facilities with capacity for delivery should be stocked with oxytocin, facilities should also be

supplied with misoprostol. Lack of stock, supplies for injection, and electricity for proper storage can

limit providers’ ability to administer oxytocin at the time of delivery. Having a second uterotonic on

hand in facilities will increase the likelihood that women will receive a uterotonic at delivery, since it can

be used if oxytocin is out of stock, or if supplies for a clean injection are unavailable. Additionally,

misoprostol is an effective treatment for PPH (Blum et al., 2007) when prophylactic administration of

oxytocin fails.

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