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Evaluation of different models of access to misoprostol at the community level to improve maternal health outcomes in Ethiopia, Ghana, and Nigeria

2016; Elsevier BV; Volume: 133; Issue: 3 Linguagem: Inglês

10.1016/j.ijgo.2016.04.002

1879-3479

Elisa Wells, Francine Coeytaux, Esther Azasi, Sada Danmusa, Takele Geressu, Tarra McNally, Jennifer Potts, Ejiro J. Otive-Igbuzor, Senait Tibebu,

Maternal and Perinatal Health Interventions

Postpartum hemorrhage is the leading cause of maternal mortality in low-income countries, accounting for more than 30% of maternal deaths [1,2], and it is arguably the most preventable [3]. The risk of hemorrhage at birth is highest for women who deliver at home because they do not benefit from the support of skilled birth attendants and are less likely to receive care and medications that prevent postpartum hemorrhage. One promising approach to the prevention of postpartum hemorrhage among these women is to provide misoprostol—an inexpensive pill that, when taken immediately after delivery, can reduce the risk of postpartum hemorrhage by 24%–47% [4–7]. Because misoprostol is easy to administer, heat stable with a long shelf life, and inexpensive, it is an invaluable tool for both the prevention and treatment of postpartum hemorrhage in under-resourced healthcare systems [8]. It is also an important alternative to oxytocin—the recommended uterotonic—in cases of stockouts or when potency has been compromised by heat exposure. In 2011, WHO added misoprostol to its List of Essential Medicines and in 2012, endorsed its use for prevention of postpartum hemorrhage by community health workers. However, it stopped short of recommending it for advanced distribution to women, citing insufficient evidence [3,9]. Since then, several studies have been conducted that provide convincing evidence of the safety of advance distribution of misoprostol [10–13], and it is anticipated that WHO will soon update its endorsement to include advance provision of misoprostol. The evidence, combined with the global focus on improving maternal health indicators to meet the 2015 Millennium Development Goals, sparked the interest of national governments and international funders in the scaling up of cost-effective community-based distribution models [7,14]. In Ethiopia, Ghana, and Nigeria, the incidence of maternal mortality due to postpartum hemorrhage is high, and many women still deliver at home (Table 1). Recognizing the potential that misoprostol could have for reducing maternal mortality in these countries, in 2004, the MacArthur Foundation began investing in a package of grants designed to explore ways to use misoprostol at the community level to prevent postpartum hemorrhage. The focus of the grants was on achieving sustainable solutions that could be scaled up nationwide. In 2014, the Foundation commissioned the Public Health Institute to do a process evaluation of these grants and document the models and approaches used to scale up the respective models in the three countries. In the present report, the models and approaches used in the three countries are described, evaluated as to their potential for achieving scale-up in the future, and compared between countries, with a highlight on the lessons learned to inform other governments committed to reducing postpartum hemorrhage and meeting the new Sustainable Development Goals. Between June and November 2014, the evaluation team reviewed grantee reports, proposals, and the literature; interviewed key informants and global, national, and local stakeholders; conducted focus group discussions with local stakeholders; and made observations during site-visits in each country. The Public Health Institute's Institutional Review Board (IRB) and each country's review board or ethics committee approved the focus group research protocols before the research was undertaken (IRB # I14-012). Overall, 100 key informants and 216 focus group participants contributed information to the evaluations. A case study report was produced for each country and the findings of the three reports were synthesized. Several models of community-based distribution of misoprostol have emerged since 2004, including advanced distribution to women through prenatal care visits or by a community agent, administration to women at birth by community health workers or traditional birth attendants, and hybrid models that include both advanced distribution directly to women before birth and distribution at birth by skilled birth attendants. The models and approaches supported by the MacArthur Foundation in Ethiopia, Ghana, and Nigeria varied across the countries. Although they had numerous elements in common, they also differed in significant ways (Table 2). Increase in uterotonic coverage of home births; Increased facility delivery Mentors and CHEWs could not always reach women with misoprostol during home births; Program viewed as inconsistent with government emphasis on facility delivery; Concern about misuse Limited resources for expansion of model to other rural areas; Concern about misuse Community structures difficult to sustain; Difficulty ensuring consistent supply of misoprostol; Concern about misuse The Ethiopia project, funded in 2008, focused on the use of lay workers to expand and support the government's health extension program by bringing misoprostol to women giving birth at home. Youth mentors, hired as part of a collaboration between the Population Council and the Ministry of Youth and Sports (now the Women, Children, and Youth Bureau), worked closely with community health extension workers from the Amhara Regional Health Bureau to expand outreach into rural communities where great distances and transportation difficulties often prevented women from delivering at health facilities. The project covered 10 Woredas (districts) and 100 rural Kebeles (wards) in the West Gojjam and North Gondar Administrative Zones of Amhara. The youth mentors went from house to house in their communities, registering pregnant women, noting their expected delivery dates, and educating them, their family members, and community leaders about postpartum hemorrhage and misoprostol. Pregnant women were instructed to call the mentors and health extension workers when labor began. The mentors were responsible for bringing the misoprostol to the birth, when either they or the health extension worker administered it a few minutes after delivery. The premise on which the Ethiopia model hinges—that lay youth mentors could help to reach women who might not otherwise be served—was proven true. The project successfully provided information about misoprostol to about half of the 5119 pregnant women living in the project areas. Additionally, there were no serious adverse events reported among women given misoprostol. However, misoprostol was administered to only 351 of the 1251 women who delivered during the 5-month project period because logistical challenges (long distances, road washouts, and unpredictable deliveries) prevented mentors and health extension workers from reaching women in labor in a timely manner. Given that no uterotonics were previously available for home births in the project area, this represented a significant increase in uterotonic coverage. Ultimately, the Ethiopia project was discontinued, primarily because of concerns about the reliance on non-health workers to distribute misoprostol and its potential use for inducing abortion. Since the project ended, the Ethiopian Government has made a major policy shift to focus on promoting institutional delivery; this will have a significant impact on future efforts to scale up community-based misoprostol distribution given the perception that the two efforts are incompatible. In 2008, the Earth Institute at Columbia University (New York, NY, USA), in partnership with the University of Illinois (IL, USA), launched a pilot project entitled the "Continuum of Care for the Prevention of Postpartum Hemorrhage," which included advance distribution of misoprostol to pregnant women. The project was implemented in the Bonsaaso Millennium Village, located in Ghana's Amansie West district in Ashanti Region. The project operated through seven primary health clinics serving a population of 30 000. In the Ghana model, health extension workers visited women in the community to educate them about prenatal care and safe delivery measures, including misoprostol. Women were encouraged to seek prenatal care, including during the third trimester when they could receive misoprostol (96% of pregnant women in Ghana attend at least one prenatal clinic [17]). During the 7-month prenatal visit, midwives educated women about safe delivery, including both the recommendation for facility delivery and how to use misoprostol for postpartum hemorrhage, and provided them with a dose of misoprostol to take home. Women who could not make it to a facility for delivery were encouraged to summon a health extension worker or traditional birth attendant to assist with home birth. Misoprostol was distributed to 654 women during the first phase of the project, 529 (80.9%) of whom delivered at a facility and did not use the pills they had been given in advance. The misoprostol was used at home by 96 (14.7%) women, all but one of whom used it correctly; no maternal death was recorded during implementation of the project [20]. The Ghana model's three key elements—integration with the health system's continuum of care; use of community health workers and traditional birth attendants for outreach, education, and delivery assistance; and advance distribution of tablets—were instrumental to its success in helping women to have safe births, whether in a facility or at home. In particular, the evaluation found that community stakeholders and policy makers had a high level of acceptance of the model; they believed that distributing misoprostol to women in advance through the healthcare system was an effective strategy for increasing uterotonic coverage at birth, both because it provided uterotonic coverage for home births when none had been previously available and also because it encouraged women to present at facilities for delivery. In 2014, a follow-on grant was approved to expand the reach of the pilot project to the entire Amansie West district and replicate it in three districts in the Savanna Accelerated Development Authority zone of Northern Ghana. Ghana is now well poised to expand community-based misoprostol services to women in other rural communities, where access to prenatal care is high but facility delivery is still limited. In 2009, Ahmadu Bello University in Zaria, and Venture Strategies Innovations conducted a pilot study in Zaria, Nigeria, using a hybrid model of distribution in which women could access misoprostol through community agents in advance of delivery or at the time of a home birth. The pilot study demonstrated that misoprostol can safely and effectively be used by women delivering at home and that its use can reduce postpartum hemorrhage during home deliveries—the pilot increased uterotonic coverage at birth, resulting in a 50% reduction in postpartum hemorrhage [21]. In 2010, the MacArthur Foundation made a strategic grant to Ahmadu Bello University to expand this model in 11 communities in Kaduna State and two in Sokoto State, anticipating that a successful replication in other states would encourage scale-up of the intervention throughout the country. The model employed the same two approaches that had been used in Zaria: community engagement designed to gain support and create demand, and community-based distribution of misoprostol directly to women in advance and at delivery. The project employed three cadres of community-based workers: traditional birth attendants to counsel pregnant women and bring them the misoprostol either before they delivered or during the delivery (in the form of clean delivery kits containing misoprostol); community oriented resource persons to counsel and support pregnant women, and help to raise community awareness of the importance of misoprostol in saving a woman's life; and drug keepers, nominated by members of the community, to stock and dispense the misoprostol to pregnant women, members of their families, and traditional birth attendants. Like the Zaria pilot, the Kaduna and Sokoto projects were perceived by key stakeholders to have been effective in preventing postpartum hemorrhage. However, the model has yet to be scaled up nationally. This is partly because it created new structures (community oriented resource persons and drug keepers) rather than integrating the approach within existing community structures (the healthcare system, social marketing programs, Ward Development Committees). As a result, it is difficult to establish and sustain in new areas. The biggest challenge the Nigeria model faces for national scale-up is a national policy that limits the distribution of misoprostol to trained community agents; as long as the Federal Ministry of Health rules that community health extension workers and traditional birth attendants are not considered "trained community agents," the Zaria model will be difficult to replicate because it revolves around the distribution of misoprostol by these community-based workers. Nevertheless, the model has served as inspiration for other initiatives, the most notable being the USAID Targeted States High Impact Project, which has adapted several aspects of the model in its efforts to take community-based distribution of misoprostol to scale in Bauchi and Sokoto States. Scaling up interventions from small pilot projects and integrating them into existing healthcare systems is difficult for any government, no matter how successful the pilot [22]. Pilot projects that incorporate recognized elements of successful scale-up from the outset—such as those that address a compelling need, are evidence-based, are endorsed by credible sources, are observable so that potential users can see the results in practice, and are compatible with the system's established values, norms, and facilities—stand the best chance of success [23]. Although all three models successfully addressed key elements necessary for scale-up—they legitimized misoprostol by generating evidence, built constituencies and gained political and community support, and modified organizational structures, successfully shifting responsibilities of health workers to increase access—none of the pilot projects has achieved full scale. The challenges inherent in scaling up misoprostol for prevention of postpartum hemorrhage are not unique to these projects; experience from around the globe suggests that efforts to scale up misoprostol for postpartum hemorrhage will require time, champions, and sustained resources [24,25]. Each country faces unique challenges but all encountered three obstacles in common: concern that community-level distribution of misoprostol would undermine efforts to increase facility deliveries; reluctance of healthcare providers and policy makers to give misoprostol to women in advance of their delivery and to trust them to use it correctly, including concerns about possible "misuse" (for induced abortion) of misoprostol by women and lay workers; and difficulties ensuring a consistent supply of misoprostol. Those that were most successful at increasing uterotonic coverage at birth incorporated the service into existing healthcare structures, which helped to ensure sustainability and will be helpful for scale-up. The collective experience of these three models of community-based distribution of misoprostol, combined with evidence from projects in other countries, provides important lessons learned and recommendations for these and other countries as they develop and scale up approaches to prevent postpartum hemorrhage. Misoprostol can save lives in countries where women still deliver at home Ensuring access to misoprostol at the community level, particularly in countries where a substantial proportion of women deliver at home, can greatly assist governments in meeting their goals to reduce maternal mortality while they continue their efforts to strengthen healthcare facilities and increase facility deliveries [4–8]. But in some places (such as in the project area in Ethiopia), the distribution of misoprostol at the community level has been curtailed because of the perception that helping women to safely deliver at home undermines the government's goal of increasing institutional deliveries. This belief—that community-based distribution competes with or even undermines women's use of health facilities—is not supported by the evidence [26–29]; in the Ghana project, working in the communities and positioning misoprostol as part of a continuum of care appears to have increased women's use of facilities (from 30% to 69% over the course of the project [unpublished data]). Advance distribution is the most successful approach, but mistrust is stalling progress The global evidence in support of advanced distribution of misoprostol to women to prevent postpartum hemorrhage is clear and incontrovertible; there is no further need for pilot studies to demonstrate the feasibility or effectiveness of this approach [7,30,31]. Nonetheless, the present evaluation found that a pervasive lack of trust in women's capabilities to use misoprostol correctly and the widely held belief that women might "misuse" the pills (for abortion) persist, despite a lack of evidence. Additionally, fears that providers (doctors, midwives, and traditional birth attendants) will inappropriately use misoprostol for labor induction and/or abortion are behind the numerous restrictions regarding who can deliver the drug to women. These restrictions pose the biggest obstacle for distribution models that depend on lay workers, who are often those most able to reach women in very rural areas. Product issues can hinder scale-up In all three countries, product issues that will have to be resolved as models scale up include packaging a single-dose misoprostol product for advanced provision to prevent postpartum hemorrhage (already available in 6 countries, including Nigeria), challenges inherent in assuring a steady supply of the drug at all levels of the delivery system, and the variable quality of available misoprostol products [32]. Distribution through existing systems has more scale-up potential In the models evaluated, the most sustainable and scalable programs embraced existing structures and access points to women. The Ghana program capitalized on the high attendance rate for prenatal care, distributing misoprostol to women who attended in their seventh month of pregnancy. Safe birth kits are another prenatal service that is being used in some places as a distribution mechanism for misoprostol. Additionally, task shifting to community health workers, traditional birth attendants, and other lay workers was successfully used in all three countries to expand the reach to more rural areas. Although not utilized in any of these three projects, all three countries have strong pharmacy and medicine vendor networks, as well as established social marketing programs. These private-sector resources are well situated to partner with the public sector to increase access to misoprostol at the community level. Providing misoprostol at the community level—although not a replacement for facility-based efforts to promote safe delivery and prevent postpartum hemorrhage—can help to save lives among women in rural areas who do not yet have access to these services. Misoprostol has the potential to be a "game changer" when it comes to maternal health, but making good on its promise to reduce postpartum hemorrhage among women who deliver at home will require moving away from the "provider" frame and addressing pervasive biases regarding women's capability to help themselves. These and other projects have shown that it can be done. The challenge now is to do it on the national scale and ensure that all women who could benefit from this simple yet effective technology have access to it. A drug as important as miso should be accessible by all and not just in specific communities. We want scale up now because the drug saves lives. The authors have no conflicts of interest.