Misoprostol and Oxytocin in Uniject® for Postpartum Hemorrhage Prevention in Communities

• Status: Withdrawn
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This community-based cluster Randomised Control Trial will assess the feasibility, cost, risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as prophylaxis for postpartum hemorrhage (PPH) in community settings. The study will be conducted in Jamnagar district in Gujarat state in India. The hypothesis is that a program to deliver oral misoprostol and one to deliver oxytocin via Uniject® will both be effective in preventing PPH when introduced in community-based settings.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: Aga Khan Health Services; Department of Health and Family Welfare, Government of Gujarat
• Treatments: Misoprostol; Oxytocin

Criteria

Inclusion Criteria:

• Pregnant women planning vaginal delivery with a trained study provider at a PHC who are eligible to participate in research according to national guidelines and able to provide informed consent.

Exclusion Criteria:

• Women not delivering in study catchment area with a trained study provider will not be eligible to participate in the trial.

• Women with known contraindications to prostaglandins, including misoprostol will also be excluded.

• Women delivering in a facility that currently routinely administers prophylactic oxytocin to women in the third stage labor will also be excluded.