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| Sponsors and Collaborators: |
Gynuity Health Projects University of Witwatersrand, South Africa Effective Care Research Unit, South Africa Family Care International |
|---|---|
| Information provided by: | Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT00124540 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Postpartum Hemorrhage |
Drug: misoprostol Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Misoprostol for Preventing Postpartum Hemorrhage |
| Enrollment: | 1200 |
| Study Start Date: | August 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
placebo resembling misoprostol
|
Drug: placebo
placebo resembling misoprosotl
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2: Experimental
misoprostol
|
Drug: misoprostol |
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Nigeria | |
| University College Hospital | |
| Ibadan, Nigeria | |
| South Africa | |
| Dora Nginza Hospital | |
| Port Elizabeth, South Africa | |
| Tembisa Hospital | |
| Johannesburg, South Africa | |
| Rob Ferreira Hospital | |
| Nelspruit, South Africa | |
| Uganda | |
| Mulago Hospital | |
| Kampala, Uganda | |
| Study Director: | Lindeka Mangesi | Effective Care Research Unit, East London Hospital Complex, South Africa |
| Principal Investigator: | G. J. Hofmeyr, MD | Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex |
More Information
| Responsible Party: | University of Witwatersrand ( Justus Hofmyer ) |
| Study ID Numbers: | 2.4.5 |
| Study First Received: | July 26, 2005 |
| Last Updated: | May 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00124540 |
| Health Authority: | South Africa: Medicines Control Council; South Africa: National Health Research Ethics Council |
|
Misoprostol Active management Postpartum hemorrhage |
Maternal morbidity Anemia Developing countries |
|
Postpartum Hemorrhage Pregnancy Complications Uterine Hemorrhage Puerperal Disorders |
Misoprostol Obstetric Labor Complications Anemia Hemorrhage |
|
Pathologic Processes Oxytocics Therapeutic Uses Anti-Ulcer Agents Physiological Effects of Drugs |
Abortifacient Agents Gastrointestinal Agents Reproductive Control Agents Abortifacient Agents, Nonsteroidal Pharmacologic Actions |
