Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births

Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.

Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use. A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta. Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.

The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. The outcome will be compared between the two treatment groups.

Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.

Inclusion Criteria: Women must be pregnant Must be able to provide informed consent Must agree to have a community health worker present at the time of delivery Must agree to participate in a follow up interview by the study midwife Must agree to have pre and postpartum haemoglobin taken Exclusion Criteria: Women who do not meet the inclusion criteria

Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.

Abbas DF, Mirzazada S, Durocher J, Pamiri S, Byrne ME, Winikoff B. Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan. Reprod Health. 2020 Jun 5;17(1):88. doi: 10.1186/s12978-020-00933-8.