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...
Date First Received: July 26, 2005
Last Updated: May 26, 2008
Verified by: Gynuity Health Projects, May 2008
Clinical Trial Phase: N/A | Start Date: August 2005
Overall Status: Completed
Estimated Enrollment: 1200
Brief Summary
Official Title: “Misoprostol for Preventing Postpartum Hemorrhage”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: September 2007
Intervention(s) in this Clinical Trial
- Drug: misoprostol
- Drug: placebo
- placebo resembling misoprosotl
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: 1
- placebo resembling misoprostol
- Experimental: 2
- misoprostol
Outcome Measures for this Clinical Trial
Primary Measures
- Blood loss =>500 mls within one hour after enrollment
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Gynuity Health Projects
Overall Clinical Trial Officials and Contacts
Lindeka Mangesi Study Director Effective Care Research Unit, East London Hospital Complex, South Africa
Additional Information
Information obtained from ClinicalTrials.gov on October 06, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00124540
Study ID Number: 2.4.5
ClinicalTrials.gov Identifier: NCT00124540
Health Authority: South Africa: Medicines Control Council
Clinical Trials Authorship and Review
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