Effect of community-based distribution of misoprostol on facility delivery: a scoping review

Maternal mortality ratios (MMR) remain high in low-and-middle-income countries (LMICs), and reduction of MMR continues to be a priority challenge in the Sustainable Development Goals (SDG) era [1]. Accordingly, to achieve the SDG of reducing the global MMR to 70 per 100,000 live births by 2030, LMICs needs to implement innovative and high impact interventions aimed at preventing and managing the main causes of maternal deaths and providing high-quality services in the continuum of maternity care [2, 3].

A wealth of evidence shows that hemorrhage is one of the major causes of maternal mortality [4‐7]. More than two-thirds of maternal deaths due to hemorrhage occur during the postpartum period, which accounts for 20% of all maternal deaths in developing regions [5]. However, in Ethiopia, a systematic review of national evidence shows that PPH accounts for 30% of maternal deaths [8, 9].

Most maternal deaths occurring due to PPH are in poorly resourced facilities or outside of a health facility where there is no access to skilled obstetric care [10‐12]. Women who deliver at home face the highest risk of PPH, as they do not benefit from the support of skilled birth attendants and are less likely to receive timely care and medications that prevent and manage PPH [12]. Evidence shows that most PPH-associated deaths could be avoided if active management of third stage of labor (AMTSL) is implemented [13], adverse outcomes and complications are prevented or managed using safe drugs in communities and facilities, and effective referral mechanisms are implemented during delivery and in the postpartum period [14]. Intravenous or intramuscular administration of uterotonics are the most essential component of AMTSL [15] and oxytocin remains the first choice uterotonics for the prevention of PPH [14].

Misoprostol distribution at community level to women during pregnancy is one of the interventions for preventing PPH to reach women who deliver at home without skilled attendant [16‐18]. Misoprostol is a generic, inexpensive, heat-stable, and potent uterotonic that can be administered orally, sublingually, rectally, and vaginally [19] for the prevention of PPH. It has considerable advantages over other uterotonics in resource-poor settings to reach woman without access to institutional delivery. Misoprostol has been studied in different setups and is endorsed by the World Health Organization (WHO) as a solution for women who give birth in facilities without oxytocin or where there is low coverage of skilled attendance [16]. Clinical trials have verified the effectiveness and safety of community distribution of misoprostol [14, 17, 20, 21] where access to skilled birth attendance and oxytocin is limited. A pooled estimate of randomized controlled trials (RCT) comparing 600 μg of oral or sublingual misoprostol with placebo in primary care or home delivery settings show that misoprostol resulted in 24 and 41% reductions in the incidence of PPH and severe PPH compared with placebo, respectively [17].

Despite the existing evidence, community-based distribution of misoprostol is still the least prioritized intervention in the maternal survival strategies [18, 22‐25]. This is due to concerns of policymakers’ and practitioners’ [12, 17, 21, 25] that misoprostol distribution at community level might decrease facility deliveries, possibly lead to misuse of misoprostol (including taking the drug before delivery, and using the drug for the purpose of inducing abortion), and lack of technologies and expertise to diagnose multiple pregnancies before using it at community levels in resource-limited settings [20, 26]. A range of other barriers at the health system, community, and policy levels are also impeding access to misoprostol for prevention of PPH. These barriers include: 1) absence of registration of misoprostol for the management of PPH [25, 27], 2) fear and apprehensions of providers and policymakers regarding its use [25, 27], 3) lack of evidence-based guidelines and provider training [25], 4) inadequate staffing and lack of knowledge and skill of providers regarding causes of PPH, and 5) limited knowledge of the community regarding the appropriate dosage and timing of administration for PPH presentation and management [20, 27].

This scoping review was, therefore, conducted to synthesize the evidence on the effect of community-based misoprostol distribution in advance of delivery on rates of facility delivery, and to assess the frequency of mothers taking distributed misoprostol before delivery, and any harmful outcomes of such misuse.

This review shows that community-based distribution of misoprostol programs have demonstrated increase of facility delivery coverage after the intervention in observational studies and no significant difference of facility delivery coverage in experimental and quasi-experimental studies among the misoprostol and control groups. The studies reviewed also found very few instances of administration of misoprostol before delivery, and no adverse outcomes because of misuse. While some studies have illustrated a concern held by policymakers and provider about misoprostol misuse, diversion of facility birth, and adverse effects of its misuse [12, 22, 26]; this scoping review showed that, so far, community-based distribution of misoprostol has not negatively impacted facility birth rates (in fact some studies show an increase in facility delivery) and has not resulted in misuse of the medication for uses other than PPH prevention. Accordingly, there is no evidence that substantiates the fear of misoprostol misuse, diversion of facility birth, and other adverse effects of its misuse. As is evident from a qualitative study in Ethiopia [26], these misconceptions arise from the health providers’ perceptions rather than the actual behavior of women using community-distributed misoprostol.

In addition, evidence shows that misoprostol is safe and effective for preventing and treating PPH in remote settings where both oxytocin and timely transfer to higher-level care are not available [21, 25, 47]. Previous studies also report that community health workers or other lower-level workers are able to safely administer misoprostol [16, 42]. Women were found to have no major problem of misusing the drug and it was found to be acceptable by them [16]. Another rapid review of the literature showed that distribution of misoprostol in advance of delivery by lay health workers for self-administration was feasible and acceptable at all levels—end-user, health system, community, and policy [20, 25].

Concerns by policymakers about misoprostol distribution at community level, often unsupported by available evidence [25], impedes the strategy being translated into effective policies, programs, and practice. Concerns primarily include fear of women using misoprostol for inducing abortion or labor, and diversion of facility birth to home deliveries [25, 39, 48]. In addition to policymaker resistance, there is a range of other barriers that impede access to a uterotonic for prevention of PPH for every woman. Barriers include service delivery challenges, supply and procurement, financial, national and global policy environments, and factors more closely connected to the end-user [49]. These implementation barriers represent important threats to any community-based misoprostol distribution program, and most of these barriers are common health system weaknesses in many LMICs [20].

Community-based distribution of misoprostol is a compelling strategy to be implemented parallel to strengthening healthcare facilities to increase safe institutional deliveries [22, 25] and ensuring universal access to uterotonics for every woman. A review by Hobday et al. recommends simultaneously promoting facility delivery and strengthening health systems to avail misoprostol at the community level [16]. Community distribution of misoprostol is thus a complementary strategy for increasing the availability of misoprostol and actively promoting facility births through increasing contact with pregnant women. Increasing interaction with pregnant women also offers the opportunity to promote early care-seeking and referral during pregnancy [20]. As such, community-based distribution of misoprostol programs should include the promotion of facility-based birth [4, 35, 42] as a critical intervention. Successful implementation of misoprostol distribution can be facilitated by creating an enabling environment through supportive policies, designing a formal plan for supplies, task shifting strategies, and appropriate use of guidelines and protocols [27]. Moreover, strong leadership and political commitment, training, and community mobilization were identified as critical success factors [20].

This study provides critical documentation of evidence to support policymakers and program managers to develop national policies and strategies for the implementation of community-based distribution of misoprostol to prevent PPH and reduce maternal mortality. It also highlights that rates of administration of misoprostol before delivery and adverse outcomes of such misuse are very low, especially when compared to the grave risks women can encounter without access to uterotonics. As such, community-based distribution of misoprostol is an appropriate strategy to be implemented while working towards achieving facility delivery as the norm.

National guidance and evidence-based policies on misoprostol distribution initiated by higher levels of the health system can facilitate reassuring reluctant policymakers and providers who hold persistent, but unfounded, fears of misuse and negative consequences. Creating opportunities for reflective discussions or policy dialogue is thus important for virtuous public health practice.

This review has some limitations. First, there may be possibility of missing some relevant studies due to the inclusion of only published studies and exclusion of studies published in a language other than English. Second, we found a small number of articles meeting the inclusion criteria and few rigorous studies directly investigated the negative effect of community availability of misoprostol on institutional delivery, misuse and adverse effects from misuse as a primary outcome. Accordingly, we could not be able to combine all the results in a meta-analysis and show pooled estimates.

Community-based distribution of misoprostol programs have been associated with an increase in coverage of facility-based births. This review found very few instances of administration of misoprostol before delivery, and no adverse outcomes of misuse in any of the studies reviewed.

Fears of misuse of misoprostol and increased adverse pregnancy outcomes if distributed at community level are not supported by evidence. Therefore, community-based distribution of misoprostol can be an appropriate strategy for reducing maternal deaths caused by postpartum hemorrhages, especially in resource-limited settings where many deliveries take place outside of health facilities.