Misoprostol for Preventing Postpartum Hemorrhage

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.

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

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: Effective Care Research Unit; Effective Care Research Unit, South Africa; Family Care International; University of Witwatersrand, South Africa
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Women who have given birth to 1 or more live-born infants (para 1 or more)

• Vaginal delivery

Exclusion Criteria:

• Refusal or inability to give informed consent

• Delivery regarded as abortion according to local gestational age limits

• Inability to take misoprostol sublingually

• Cesarean section

• Assisted vaginal delivery