A Placebo-randomized Controlled Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan (Juanita Hatcher)
This is a community based randomized controlled trial of oral misoprostol versus placebo (coated to resemble misoprostol) in the prevention of post partum haemorrhage in home births in rural northern Pakistan.
The study will provide answers to the following questions:
- is there a clinically meaningful difference in postpartum hemorrhage (blood loss ? 500 ml), intermediate PPH (blood loss = 750 ml) and severe PPH(blood loss ? 1000 ml) between women given the misoprostol regimen and those given placebo?
- is there a meaningful difference in the proportion of women who have a decrease in hemoglobin (Hb) > 2 g/dl from pre to post delivery between women in the two study arms.
- is there a meaningful difference in mean blood loss between women given the misoprostol and those given placebo?
- will this intervention reduce anemia (< 9 g/dl and <11 g/dl)?
- are the side effects of misoprostol, previously shown to be clinically mild, tolerable for women?
Funder: Gynuity Health Program, USA