Abstract
BackgroundPostpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. In Afghanistan, where most births take place at home without the assistance of a skilled birth attendant, there is a need for options to manage PPH in community-based settings. Misoprostol, a uterotonic that has been used as prophylaxis at the household level and has also been proven to be effective in treating PPH in hospital settings, is one possible option.MethodsA double-blind, randomized placebo-controlled trial was conducted in six districts in Badakhshan Province, Afghanistan to test the effectiveness and safety of administering 800mcg sublingual misoprostol to women after a home birth for treatment of excessive blood loss. Consenting women were enrolled prior to delivery and given 600mcg misoprostol to self-administer orally as prophylaxis. Community health workers (CHW) were trained to observe for signs of PPH after delivery and if PPH was diagnosed, administer the study medication (misoprostol or placebo) and immediately refer the woman. A hemoglobin (Hb) decline of 2 g/dL or greater, measured pre- and post-delivery, served as the primary outcome; side effects, additional interventions, and transfer rates were also analyzed.ResultsAmong the 1884 women who delivered at home, nearly all (98.7%) reported self-use of misoprostol for PPH prevention. A small fraction was diagnosed with PPH (4.4%, 82/1884) and was administered treatment. Hb outcomes, including the proportion of women with a Hb drop of 2 g/dL or greater, were similar between the study groups (misoprostol: 56.4% (22/39), placebo: 60.6% (20/33), p = 0.45). Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03). Other side effects were similar between study groups and none required treatment, including among the subset of 39 women, who received misoprostol for both of its PPH indications.ConclusionsWhile the study did not document a clinical benefit associated with misoprostol for treatment of PPH, study findings suggest that use of misoprostol for both prevention and treatment in the same birth as well as its use by lay level providers in home births does not result in any safety concerns.Trial registrationThis trial was registered with ClinicalTrials.gov, number NCT01508429 Registered on December 1, 2011.
Highlights
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide
While the study did not document a clinical benefit associated with misoprostol for treatment of postpartum hemorrhage (PPH), study findings suggest that use of misoprostol for both prevention and treatment in the same birth as well as its use by lay level providers in home births does not result in any safety concerns
Building on the national PPH strategy in Afghanistan, this study aimed to test the programmatic feasibility of equipping women with 600mcg oral misoprostol for self-use for PPH prevention after homebirth, in addition to training and supplying Community health workers (CHW) to offer a treatment dose of misoprostol (800mcg sublingually) when PPH is observed in the home
Summary
In Afghanistan, where most births take place at home without the assistance of a skilled birth attendant, there is a need for options to manage PPH in community-based settings. Misoprostol, an E-1 prostaglandin, is known for its efficacy in managing postpartum hemorrhage (PPH) [1,2,3]. Both international and country guidelines have incorporated misoprostol into clinical protocols and recommendations for prevention and treatment of PPH [4,5,6]. Misoprostol’s oral formulation and heat stable characteristic make it a versatile option to use at all levels of the health system, and evidence supports its use for both indications [7, 8]. Despite more than a decade of community research on the use of this medicine, there remains a gap in evidence on the use of misoprostol for both indications in the same delivery as part of a continuum of care, service delivery model at the community level
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