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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: El Galaa Teaching Hospital; Faculty of Medicine, Alexandria University; Ministry of Health and Population, Egypt; University of Alexandria
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Willing and able to give informed consent

• Vaginal delivery

• Agrees to participate in follow-up interview

• Agrees to have pre- and post-hemoglobin taken

• Delivery at woman's home or at the primary health unit (PHU)

Exclusion Criteria:

• Too advanced into active labor to provide consent

• Known allergy to misoprostol and/or other prostaglandin

• Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester