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

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.

Conditions

• Postpartum Hemorrhage

Interventions

DRUG

Misoprostol

Selective administration of 800 mcg sublingual misoprostol to women with at least 350 mL blood loss within 1 hour following delivery

DRUG

Misoprostol

Universal administration of 600 mcg oral misoprostol given to all women within 5 minutes of delivery of the baby

Sponsors & Collaborators

• Sri B. M. Patil Medical College, Bijapur, Karnataka, India

  collaborator UNKNOWN

• Jawaharlal Nehru Medical College

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Gynuity Health Projects

  lead OTHER

Principal Investigators

• Beverly Winikoff, MD, MPH · Gynuity Health Projects

• Sheila Raghavan, MSc · Gynuity Health Projects

• Stacie Gellar, PhD · University of Illinois at Chicago

• Suellen Miller, PhD, CNM · University of California, San Francisco

• Shivaprasad S Goudar, MD, MHPE · Jawaharlal Nehru Medical College

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• India

Study Locations