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Background: Mozambique has high maternal mortality which is compounded by limited human resources for health, weak access to health services, and poor development indicators. In 2011, the Mozambique Ministry of Health (MoH) approved the distribution of misoprostol for the prevention of post-partum haemorrhage (PPH) at home births where oxytocin is not available. Misoprostol can be administered by a traditional birth attendant or self-administered. The objective of this paper is to examine, through applying a human rights lens, the broader contextual, policy and institutional issues that have influenced and impacted the early implementation of misoprostol for the prevention of PPH. We explore the utility of rights-based framework to inform this particular program, with implications for sexual and reproductive health programs more broadly., Methods: A human rights, health and development framework was used to analyse the early expansion phase of the scale-up of Mozambique's misoprostol program in two provinces. A policy document review was undertaken to contextualize the human rights, health and development setting in Mozambique. Qualitative primary data from a program evaluation of misoprostol for the prevention of PPH was then analysed using a human rights lens; these results are presented alongside three examples where rights are constrained., Results: Structural and institutional challenges exacerbated gaps in the misoprostol program, and sexual and reproductive health more generally. While enshrined in the constitution and within health policy documents, human rights were not fully met and many individuals in the study were unaware of their rights. Lack of information about the purpose of misoprostol and how to access the medication contributed to power imbalances between the state, health care workers and beneficiaries. The accessibility of misoprostol was further limited due to dynamics of power and control., Conclusions: Applying a rights-based approach to the Mozambican misoprostol program is helpful in contextualising and informing the practical changes needed to improve access to misoprostol as an essential medicine, and in turn, preventing PPH. This study adds to the evidence of the interconnection between human rights, health and development and the importance of integrating the concepts to ensure women's rights are prioritized within health service delivery.

Background: Mozambique has a high maternal mortality ratio, and postpartum hemorrhage (PPH) is a leading cause of maternal deaths. In 2015, the Mozambican Ministry of Health (MOH) commenced a program to distribute misoprostol at the community level in selected districts as a strategy to reduce PPH. This case study uses the ExpandNet/World Health Organization (WHO) scale-up framework to examine the planning, management, and outcomes of the early expansion phase of the scale-up of misoprostol for the prevention of PPH in 2 provinces in Mozambique., Methods: Qualitative semistructured interviews were conducted between February and October 2017 in 5 participating districts in 2 provinces. Participants included program stakeholders, health staff, community health workers (CHWs), and traditional birth attendants (TBAs). Interviews were analyzed using the ExpandNet/WHO framework alongside national policy and planning documents and notes from a 2017 national Ministry of Health maternal, newborn, and child health workshop. Outcomes were estimated using misoprostol coverage and access in 2017 for both provinces., Results: The study revealed a number of barriers and facilitators to scale-up. Facilitators included a supportive political and legal environment; a clear, credible, and relevant innovation; early expansion into some Ministry of Health systems and a strong network of CHWs and TBAs. Barriers included a reduction in reach due to a shift from universal distribution to application of eligibility criteria; fear of misdirecting misoprostol for abortion or labor induction; limited communication and understanding of the national PPH prevention strategy; inadequate monitoring and evaluation; challenges with logistics systems; and the inability to engage remote TBAs. Lower coverage was found in Inhambane province than Nampula province, possibly due to NGO support and political champions., Conclusion: This study identified the need for a formal review of the misoprostol program to identify adaptations and to develop a systematic scale-up strategy to guide national scale-up., (© Hobday et al.)

Background: Post-partum haemorrhage is the leading cause of maternal deaths in Mozambique. In 2015, the Mozambican Ministry of Health launched the National Strategy for the Prevention of Post-Partum Haemorrhage at the Community Level. The strategy included the distribution of misoprostol to women in advance at antenatal care and via Traditional Birth Attendants who directly administer the medication. The study explores the role of Traditional Birth Attendants in the misoprostol program and the views of women who used misoprostol to prevent post-partum haemorrhage., Methods: This descriptive study collected data through in-depth interviews and focus group discussions. Traditional Birth Attendants between the ages of 30-70 and women of reproductive age participated in the study. Data was collected between June-October 2017 in Inhambane and Nampula Provinces. Line by line thematic analysis was used to interpret the data using Nvivo (v.11)., Results: The majority of TBAs in the study were satisfied with their role in the misoprostol program and were motivated to work with the formal health system to encourage women to access facility based births. Women who used misoprostol were also satisfied with the medication and encouraged family and friends to access it when needed. Women in the community and Traditional Birth Attendants requested assistance with transportation to reach the health facility to avoid home births., Conclusions: This study contributes to the evidence base that Traditional Birth Attendants are an appropriate channel for the distribution of misoprostol for the prevention of post-partum haemorrhage at the community level. More support and resources are needed to ensure Traditional Birth Attendants can assist women to have safe births when they are unable to reach the health facility. A consistent supply of misoprostol is needed to ensure women at the community level receive this life saving medication.

Achieving Sustainable Development Goal targets for 2030 will require persistent investment and creativity in improving access to quality health services, including skilled attendance at birth and access to emergency obstetric care. Community-based misoprostol has been extensively studied and recently endorsed by the WHO for the prevention of post-partum haemorrhage. There remains little consolidated information about experience with implementation and scale-up to date. This narrative review of the literature aimed to identify the political processes leading to WHO endorsement of misoprostol for the prevention of post-partum haemorrhage and describe ongoing challenges to the uptake and scale-up at both policy and community levels. We review the peer-reviewed and grey literature on expansion and scale-up and present the issues central to moving forward.

In Nigeria, most deaths due to postpartum hemorrhage (PPH) occur in the absence of skilled birth attendants. A study using community mobilization and the training of community drug keepers to increase access to misoprostol for PPH prevention was conducted in five communities around Zaria in Kaduna State, Nigeria. Community-oriented resource persons (CORPs) and traditional birth attendants (TBAs) recruited and counseled pregnant women on bleeding after delivery, the importance of delivery at a health facility, and the role of misoprostol. Drug keepers stored and dispensed misoprostol during a woman's third trimester of pregnancy. TBAs and CORPs enrolled 1,875 women from January through December 2009. These results are based on 1,577 completed postpartum interviews. Almost all women delivered at home (95%) and skilled attendance at delivery was low (7%). The availability of misoprostol protected 83% of women who delivered at home against PPH who otherwise would not have been protected. Policymakers working in similar contexts should consider utilizing commuity-level distribution models to reach women with this life-saving intervention.

A consensus emerged in the late 1990s among leaders in global maternal health that traditional birth attendants (TBAs) should no longer be trained in delivery skills and should instead be trained as promoters of facility-based care. Many TBAs continue to be trained in places where home deliveries are the norm and the potential impacts of this training are important to understand. The primary objective of this study was to gain a more nuanced understanding of the full impact of training TBAs to use misoprostol and a blood measurement tool (mat) for the prevention of postpartum haemorrhage (PPH) at home deliveries through the perspective of those involved in the project. This qualitative study, conducted between July 2009 and July 2010 in Bangladesh, was nested within larger operations research, testing the feasibility and acceptability of scaling up community-based provision of misoprostol and a blood measurement tool for prevention of PPH. A total of 87 in-depth interviews (IDIs) were conducted with TBAs, community health workers (CHWs), managers, and government-employed family welfare visitors (FWVs) at three time points during the study. Computer-assisted thematic data analysis was conducted using ATLAS.ti (version 5.2). Four primary themes emerged during the data analysis, which all highlight changes that occurred following the training. The first theme describes the perceived direct changes linked to the two new interventions. The following three themes describe the indirect changes that interviewees perceived: strengthened linkages between TBAs and the formal healthcare system; strengthened linkages between TBAs and the communities they serve; and improved quality of services/service utilization. The data indicate that training TBAs and CHW supervisors resulted in perceived broader and more nuanced changes than simply improvements in TBAs' knowledge, attitudes, and practices. Acknowledgeing TBAs' important role in the community and in home deliveries and integrating them into the formal healthcare system has the potential to result in changes similar to those seen in this study.

Background: Bangladesh is one of the few countries that may actually achieve the fifth Millennium Development Goal (MDG) in time, despite skilled birth attendance remaining low. The purpose of this paper is to examine the potential role misoprostol can play in the decline of maternal deaths attributed to postpartum hemorrhage (PPH) in Bangladesh., Methods: Using data from a misoprostol and blood loss measurement tool feasibility study in Bangladesh, observed cause specific maternal mortality ratios (MMRs) were estimated and contrasted with expected ratios using estimates from the Bangladesh Maternal Mortality Survey (BMMS) data. Using Crystal Ball 7 we employ Monte Carlo simulation techniques to estimate maternal deaths in four scenarios, each with different levels of misoprostol coverage. These scenarios include project level misoprostol coverage (69%), no (0%), low (40%), and high (80%) misoprostol coverage. Data on receipt of clean delivery kit, use of misoprostol, experience of PPH, and cause of death were used in model assumptions., Results: Using project level misoprostol coverage (69%), the mean number of PPH deaths expected was 40 (standard deviation = 8.01) per 100,000 live births. Assuming no misoprostol coverage (0%), the mean number of PPH deaths expected was 51 (standard deviation = 9.30) per 100,000 live births. For low misoprostol coverage (40%), the mean number of PPH deaths expected was 45 (standard deviation = 8.26) per 100,000 live births, and for high misoprostol coverage (80%), the mean number of PPH deaths expected was 38 (standard deviation = 7.04) per 100,000 live births., Conclusion: This theoretical exercise hypothesizes that prophylactic use of misoprostol at home births may contribute to a reduction in the risk of death due to PPH, in addition to reducing the incidence of PPH. If findings from this modeling exercise are accurate and uterotonics can prevent maternal death, misoprostol could be the tool countries need to further reduce maternal mortality at home births.

Background: Hemorrhage is the leading cause of maternal mortality in Bangladesh, the majority of which is due to postpartum hemorrhage (PPH), blood loss of 500 mL or more. Many deaths due to PPH occur at home where approximately 77% of births take place. This paper aims to determine whether the attendant at home delivery (i.e. traditional birth attendant (TBA) trained on PPH interventions, TBA not trained on interventions, or lay attendant) is associated with the use of interventions to prevent PPH at home births., Methods: Data come from operations research to determine the safety, feasibility, and acceptability of scaling-up community-based provision of misoprostol and an absorbent delivery mat in rural Bangladesh. Analyses were done using data from antenatal care (ANC) cards of women who delivered at home without a skilled attendant (N =66,489). Multivariate logistic regression was used to assess the likelihood of using the interventions., Results: Overall, 67% of women who delivered at home without a skilled provider used misoprostol and the delivery mat (the interventions). Women who delivered at home and had a trained TBA present had 2.72 (95% confidence interval, 2.15-3.43) times the odds of using the interventions compared to those who had a lay person present. With each additional ANC visit (maximum of 4) a woman attended, the odds of using the interventions increased 2.76 times (95% confidence interval, 2.71-2.81). Other sociodemographic variables positively associated with use of the interventions were age, secondary or higher education, and having had a previous birth., Conclusion: Findings indicate that trained TBAs can have a significant impact on utilization of interventions to prevent PPH in home births. ANC visits can be an important point of contact for knowledge transfer and message reinforcement about PPH prevention.

The wide gap in maternal mortality ratios worldwide indicates major inequities in the levels of risk women face during pregnancy. Two priority strategies have emerged among safe motherhood advocates: increasing the quality of emergency obstetric care facilities and deploying skilled birth attendants. The training of traditional birth attendants, a strategy employed in the 1970s and 1980s, is no longer considered a best practice. However, inadequate access to emergency obstetric care and skilled birth attendants means women living in remote areas continue to die in large numbers from preventable maternal causes. This paper outlines an intervention to address the leading direct cause of maternal mortality, postpartum haemorrhage. The potential for saving maternal lives might increase if community-based birth attendants, women themselves, or other community members could be trained to use misoprostol to prevent postpartum haemorrhage. The growing body of evidence regarding the safety and efficacy of misoprostol for this indication raises the question: if achievement of the fifth Millennium Development Goal is truly a priority, why can policy makers and women's health advocates not see that misoprostol distribution at the community level might have life-saving benefits that outweigh risks?

Background: Hemorrhage continues to be a leading cause of maternal death in developing countries. The 2012 World Health Organization guidelines for the prevention and management of postpartum hemorrhage (PPH) recommend oral administration of misoprostol by community health workers (CHWs). However, there are several outstanding questions about distribution of misoprostol for PPH prevention at home births., Methods: We conducted an integrative review of published research studies and evaluation reports from programs that distributed misoprostol at the community level for prevention of PPH at home births. We reviewed methods and cadres involved in education of end-users, drug administration, distribution, and coverage, correct and incorrect usage, and serious adverse events., Results: Eighteen programs were identified; only seven reported all data of interest. Programs utilized a range of strategies and timings for distributing misoprostol. Distribution rates were higher when misoprostol was distributed at a home visit during late pregnancy (54.5-96.9%) or at birth (22.5-83.6%), compared to antenatal care (ANC) distribution at any ANC visit (22.5-49.1%) or late ANC visit (21.0-26.7%). Coverage rates were highest when CHWs and traditional birth attendants distributed misoprostol and lower when health workers/ANC providers distributed the medication. The highest distribution and coverage rates were achieved by programs that allowed self-administration. Seven women took misoprostol prior to delivery out of more than 12,000 women who were followed-up. Facility birth rates increased in the three programs for which this information was available. Fifty-one (51) maternal deaths were reported among 86,732 women taking misoprostol: 24 were attributed to perceived PPH; none were directly attributed to use of misoprostol. Even if all deaths were attributable to PPH, the equivalent ratio (59 maternal deaths/100,000 live births) is substantially lower than the reported maternal mortality ratio in any of these countries., Conclusions: Community-based programs for prevention of PPH at home birth using misoprostol can achieve high distribution and use of the medication, using diverse program strategies. Coverage was greatest when misoprostol was distributed by community health agents at home visits. Programs appear to be safe, with an extremely low rate of ante- or intrapartum administration of the medication.

A 50-fold disparity in maternal mortality exists between high- and low-income countries, and in most contexts, the single most common cause of maternal death is postpartum hemorrhage (PPH). In Bangladesh, as in many other low-income countries, the majority of deliveries are conducted at home by traditional birth attendants (TBAs) or family members. In the absence of skilled birth attendants, training TBAs in the use of misoprostol and an absorbent delivery mat to measure postpartum blood loss may strengthen the ability of TBAs to manage PPH. These complementary interventions were tested in operations research among 77,337 home births in rural Bangladesh. The purpose of this study was to evaluate TBAs' knowledge acquisition, knowledge retention, and changes in attitudes and practices related to PPH management in home births after undergoing training on the use of misoprostol and the blood collection delivery mat. We conclude that the training was highly effective and that the two interventions were safely and correctly used by TBAs at home births. Data on TBA practices indicate adherence to protocol, and 18 months after the interventions were implemented, TBA knowledge retention remained high. This program strengthens the case for community-based use of misoprostol and warrants consideration of this intervention as a potential model for scale-up in settings where complete coverage of skilled birth attendants (SBAs) remains a distant goal., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

The purpose of this study is to demonstrate the importance of community mobilization in the uptake of a health intervention, namely, community-based distribution of misoprostol to prevent postpartum hemorrhage. Community mobilization to increase access to misoprostol for postpartum hemorrhage prevention was implemented in northwestern Nigeria in 2009. Theories of community participation and the current near-epidemic maternal mortality conditions underpin an approach using modest levels of community involvement. The study was undertaken in five communities around Zaria, Nigeria. Community leaders and selected community members participated in a series of dialogs. Additionally, community education, information and dramas sessions were held. Twenty nine community oriented resource persons (CORPs), 27 drug keepers and 41 traditional birth attendants (TBAs) were involved in the intervention. Postpartum interviews were used to assess the impact of community mobilization efforts and to track use of misoprostol. Multiple logistic regression was used to examine the association between correct use and receiving information regarding misoprostol from TBAs or CORPs. A total of 1875 women were enrolled in the study in 2009. Most women delivered at home (95%) and skilled attendance at delivery was low (7%). Community mobilization efforts reached most women with information about postpartum hemorrhage and misoprostol (88%), resulting in high comprehension of intervention messages. Women identified TBAs and CORPs as the single most important source of information about misoprostol 41% and 31% of the time, respectively. Availability of misoprostol at the community level gave 79% of enrolled women some protection against postpartum hemorrhage which they otherwise would not have had. Although high level community participation in health care interventions is the ideal, this study suggests that even in circumstances where only modest levels of participation can realistically be achieved, community mobilization can have a significant impact on the successful distribution and uptake of a potentially life-saving health intervention, in turn helping promote policy change., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Background: Knowledge on how well we can predict primary postpartum hemorrhage (PPH) can help policy makers and health providers design current delivery protocols and PPH case management. The purpose of this paper is to identify risk factors and determine predictive probabilities of those risk factors for primary PPH among women expecting singleton vaginal deliveries in Egypt., Methods: From a prospective cohort study, 2510 pregnant women were recruited over a six-month period in Egypt in 2004. PPH was defined as blood loss ≥ 500 ml. Measures of blood loss were made every 20 minutes for the first 4 hours after delivery using a calibrated under the buttocks drape. Using all variables available in the patients' charts, we divided them in ante-partum and intra-partum factors. We employed logistic regression to analyze socio-demographic, medical and past obstetric history, and labor and delivery outcomes as potential PPH risk factors. Post-model predicted probabilities were estimated using the identified risk factors., Results: We found a total of 93 cases of primary PPH. In multivariate models, ante-partum hemoglobin, history of previous PPH, labor augmentation and prolonged labor were significantly associated with PPH. Post model probability estimates showed that even among women with three or more risk factors, PPH could only be predicted in 10% of the cases., Conclusions: The predictive probability of ante-partum and intra-partum risk factors for PPH is very low. Prevention of PPH to all women is highly recommended.

This paper evaluates the safety and acceptability of long-term community-based use of misoprostol for management of postpartum hemorrhage (PPH) in home-births, by comparing deliveries with and without misoprostol use in communities of Kigoma, Tanzania. We administered a standardized survey instrument to women who delivered between August 2004 and May 2007. 940 women completed questionnaires, corresponding to 950 deliveries. Findings showed that the majority of TBAs administered misoprostol at the correct time (76%). Receipt of three or five tablets was most commonly reported (47% and 43% respectively). Misoprostol users were significantly more likely to experience shivering, high temperature, nausea, and vomiting after delivery; adjustment for gynecological history and delivery characteristics revealed no significant differences in experience of symptoms. Misoprostol was highly acceptable to all women surveyed. Misoprostol at the community level is a safe intervention.

This paper sought to determine the safety and feasibility of home-based prophylaxis of postpartum hemorrhage (PPH) with misoprostol, including assessment of the need for referrals and additional interventions. In rural Tigray, Ethiopia, traditional birth attendants (TBAs) in intervention areas were trained to administer 600mcg of oral misoprostol. In non-intervention areas women were referred to the nearest health facility. Of the 966 vaginal deliveries attended by TBAs, only 8.9% of those who took misoprostol prophylactically (n = 485) needed additional intervention due to excessive bleeding compared to 18.9% of those who did not take misoprostol (n = 481).The experience of symptoms among those who used misoprostol can be considered of minor relevance and self-contained. This study found that prophylactic use of misoprostol in home births is a safe and feasible intervention. Community health care workers trained in its use can correctly and effectively administer misoprostol and be a champion in reducing PPH morbidity and mortality.

The current paper examines the realities of women delivering in resource-poor settings, and recommends cost-effective, scalable strategies for making these deliveries safer. Ninety-five percent of maternal deaths occur in poor settings, and the largest proportion of these deaths are women who deliver at home, far away from health care facilities, and without financial access to skilled providers. This situation will improve only when policymakers and programme planners refocus their attention on service delivery and financing interventions, with the potential to reach the largest portion of women living in places where mortality is the highest. We suggest three feasible interventions that can potentially minimise both demand and supply side problems of safe delivery: (1) misoprostol to treat postpartum haemorrhage, an easy to use and heat stable technology to reduce the leading cause of maternal deaths; (2) alternative providers, such as clinical officers, trained to offer emergency obstetric care services; (3) financing safe delivery through vouchers or other mechanisms that can be implemented in poor settings and made attractive to the donor community through output-based assistance (OBA).

Objective: To test the cost-effectiveness of training traditional birth attendants (TBAs) to recognize postpartum hemorrhage (PPH) and administer a rectal dose of misoprostol in areas with low access to modern delivery facilities., Method: A cost-effectiveness analysis, modeling two hypothetical cohorts of 10,000 women each giving birth with TBAs: one under standard treatment (TBA referral to hospital after blood loss >or=500 ml), and one attended by TBAs trained to recognize PPH and to administer 1000 microg of misoprostol at blood loss >or=500 ml., Result: The misoprostol strategy could prevent 1647 cases of severe PPH (range: 810-2920) and save $115,335 in costs of referral, IV therapy and transfusions (range: $13,991-$1,563,593) per 10,000 births. By preventing severe disease and saving money, it dominates the standard approach., Conclusion: Training TBAs to administer misoprostol to treat PPH has the potential to both save money and improve the health of mothers in low-resource settings.

Objective: To compare current practices for the active management of the third stage of labor (AMTSL) with the use of 600 mug of oral misoprostol., Methods: An operations research study was designed to compare blood loss with current AMTSL practices and misoprostol use., Results: Women in the misoprostol group were less likely to bleed 500 ml or more (adjusted odds ratio, 0.30; 95% confidence interval, 0.16-0.56) compared with those in the current practices group. In the current practices group 73% women required interventions because of postpartum hemorrhage, compared with 11% in the misoprostol group., Conclusion: In situations where oxytocin and or ergometrine are not consistently and appropriately used during third stage of labor, misoprostol should be considered for inclusion in the AMTSL protocol.

Objectives: Determine safety of household management of postpartum hemorrhage (PPH) with 1000 microg of rectal misoprostol, and assess possible reduction in referrals and the need for additional interventions., Methods: Traditional birth attendants (TBAs) in Kigoma, Tanzania were trained to recognize PPH (500 ml of blood loss). Blood loss measurement was standardized by using a local garment, the "kanga". TBAs in the intervention area gave 1000 microg of misoprostol rectally when PPH occurred. Those in the non-intervention area referred the women to the nearest facility., Results: 454 women in the intervention and 395 in the non-intervention areas were eligible. 111 in the intervention area and 73 in the non-intervention had PPH. Fewer than 2% of the PPH women in the intervention area were referred, compared with 19% in the non-intervention., Conclusion: Misoprostol is a low cost, easy to use technology that can control PPH even without a medically trained attendant.