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

A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.

A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level. The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.

women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)

4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth

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.

number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided

serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.

Inclusion Criteria: Women who deliver at home with a study TBA present. Women must be willing and able to provide informed consent Women must agree to participate in a follow up interview Women must agree to have pre and post-partum haemoglobin taken Exclusion Criteria: If the woman does not meet any of the above outlined 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, Jehan N, Diop A, Durocher J, Byrne ME, Zuberi N, Ahmed Z, Walraven G, Winikoff B. Using misoprostol to treat postpartum hemorrhage in home deliveries attended by traditional birth attendants. Int J Gynaecol Obstet. 2019 Mar;144(3):290-296. doi: 10.1002/ijgo.12756. Epub 2019 Jan 24.