Clinical Trials Directory

Trials / Completed

CompletedNCT00124540

Misoprostol for Preventing Postpartum Hemorrhage

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,200 (actual)
Sponsor
Gynuity Health Projects · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGmisoprostol
DRUGplaceboplacebo resembling misoprosotl

Timeline

Start date
2005-08-01
Primary completion
2007-09-01
Completion
2007-10-01
First posted
2005-07-28
Last updated
2008-05-28

Locations

5 sites across 3 countries: Nigeria, South Africa, Uganda

Source: ClinicalTrials.gov record NCT00124540. Inclusion in this directory is not an endorsement.