Misoprostol for Secondary Prevention of Postpartum Hemorrhage at the Community Level in India

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study compares two community-level strategies: selective administration of 800 mcg sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for primary prevention of PPH. The study hypothesizes that at community-level births, secondary prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis provided to women for primary prevention of PPH. This cluster-design non-inferiority trial has the potential to inform service delivery programs on clinical outcomes, program feasibility, cost and acceptability of two different community models of PPH care using misoprostol.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: Jawaharlal Nehru Medical College; Sri B. M. Patil Medical College, Bijapur, Karnataka, India; University of California, San Francisco; University of Illinois at Chicago
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

1. delivering at home or sub-center with an auxilliary nurse midwife (ANM)

2. able and willing to provide informed consent

3. meeting Ministry of Health Guidelines for home or sub-center delivery

Exclusion Criteria:

1. high-risk pregnancy