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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,600
600 mcg oral misoprostol administered during third stage of labor
Home delivery setting
Chitral, Chitral District, Pakistan
Postpartum hemorrhage (blood loss >or= 500 mL)
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
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
Mean blood loss
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
Anemia (<9 g/dL and <11 g/dL)
Time frame: Postpartum hemoglobin assessed 3 days post-delivery
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