Misoprostol for Preventing Postpartum Hemorrhage
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...
Brief Summary
Official Title: “Misoprostol for Preventing Postpartum Hemorrhage”
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
- 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 Investigator Information
Lead Investigator: Gynuity Health Projects Other
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00124540
