Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan
This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated...
Brief Summary
Official Title: “A Placebo-Controlled Randomized Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan”
This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.
- 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: July 2008
Intervention(s) in this Clinical Trial
- Drug: Misoprostol
- 600 mcg oral misoprostol administered during third stage of labor
Outcome Measures for this Clinical Trial
Primary Measures
- Postpartum hemorrhage (blood loss >or= 500 mL)
- Time Frame: Measured at 1 hour postpartum or until active bleeding has stopped
Safety Issue?: Yes
- Time Frame: Measured at 1 hour postpartum or until active bleeding has stopped
- Drop in hemoglobin > 2 g/dL from pre to post-delivery
- Time Frame: Hemoblobin (Hb) level measured 3-5 days after delivery
Safety Issue?: Yes
- Time Frame: Hemoblobin (Hb) level measured 3-5 days after delivery
Secondary Measures
- Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL)
- Time Frame: Blood loss measured at 1 hr postpartum or until active bleeding stopped
Safety Issue?: Yes
- Time Frame: Blood loss measured at 1 hr postpartum or until active bleeding stopped
- Mean blood loss
- Time Frame: blood loss measured at 1 hr postpartum or until active bleeding stopped
Safety Issue?: Yes
- Time Frame: blood loss measured at 1 hr postpartum or until active bleeding stopped
- Side effects experienced among recently delivered mothers
- Time Frame: Interviews conducted 1 day post-delivery
Safety Issue?: Yes
- Time Frame: Interviews conducted 1 day post-delivery
- Anemia (<9 g/dL and <11 g/dL)
- Time Frame: Postpartum hemoglobin assessed 3 days post-delivery
Safety Issue?: Yes
- Time Frame: Postpartum hemoglobin assessed 3 days post-delivery
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Pregnant women in general good health, home delivery
- Must live in one of 78 study villages
Exclusion Criteria:
- Hypertension
- Non-cephalic presentation
- Polyhydramnios
- Previous cesarean section
- Suspected multiple pregnancy
- Suspected still birth
- Antepartum hemorrhage
- Previous complication in 3rd trimester
- Anemia of <8 g/dl
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
Gijs Walraven, MD Principal Investigator Aga Khan University
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00120237
Study ID Number: 2.4.4
ClinicalTrials.gov Identifier: NCT00120237
Health Authority: Pakistan: Research Ethics Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00120237
