Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan
Not Applicable
Completed
- Conditions
- Postpartum HemorrhageAnemia
- Registration Number
- NCT00120237
- Lead Sponsor
- Gynuity Health Projects
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1600
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postpartum hemorrhage (blood loss >or= 500 mL) Measured at 1 hour postpartum or until active bleeding has stopped Drop in hemoglobin > 2 g/dL from pre to post-delivery Hemoblobin (Hb) level measured 3-5 days after delivery
- Secondary Outcome Measures
Name Time Method Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL) Blood loss measured at 1 hr postpartum or until active bleeding stopped Mean blood loss blood loss measured at 1 hr postpartum or until active bleeding stopped Side effects experienced among recently delivered mothers Interviews conducted 1 day post-delivery Anemia (<9 g/dL and <11 g/dL) Postpartum hemoglobin assessed 3 days post-delivery
Trial Locations
- Locations (1)
Home delivery setting
🇵🇰Chitral, Chitral District, Pakistan