Misoprostol for Preventing Postpartum Hemorrhage
- Registration Number
- NCT00124540
- Lead Sponsor
- Gynuity Health Projects
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo placebo resembling misoprostol 2 misoprostol misoprostol
- Primary Outcome Measures
Name Time Method Blood loss =>500 mls within one hour after enrollment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
Mulago Hospital
🇺🇬Kampala, Uganda
Rob Ferreira Hospital
🇿🇦Nelspruit, South Africa
Dora Nginza Hospital
🇿🇦Port Elizabeth, South Africa
Tembisa Hospital
🇿🇦Johannesburg, South Africa
University College Hospital
🇳🇬Ibadan, Nigeria