Clinical Trial: Misoprostol for Preventing Postpartum Hemorrhage

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Misoprostol for Preventing Postpartum Hemorrhage

Brief 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.

Detailed Summary:
Sponsor: Gynuity Health Projects

Current Primary Outcome: Blood loss =>500 mls within one hour after enrollment

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood loss =>1000 mls within one hour after enrollment
  • Mean blood loss after enrollment
  • Blood transfusion
  • Hemoglobin level <8 g/dL 24 hours after delivery
  • Maternal morbidity and mortality
  • Side effects


Original Secondary Outcome: Same as current

Information By: Gynuity Health Projects

Dates:
Date Received: July 26, 2005
Date Started: August 2005
Date Completion:
Last Updated: May 26, 2008
Last Verified: May 2008