drugset / Trial / NCT02226588

Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt

NCT02226588

RandomizedParallel-groupOpen-labelPrevention

Summary

The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.

Timeline

Start
2014-10
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 600 ug Subcutaneous
Subject Misoprostol Other / unclassified 800 ug Subcutaneous

Indications

No indication recorded.