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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborator: Aga Khan Health Services
• Treatments: Misoprostol

Criteria

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