NCT01508429

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Postpartum Hemorrhage (PPH)

Interventions

Type	Name	Description
OTHER	placebo	4 placebo tablets (resembling misoprostol) administered sublingually
DRUG	Misoprostol	800mcg misoprostol (4 200mcg tablets administered sublingually)

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-01-12
• Last updated: 2016-07-11

Locations

1 site across 1 country: Afghanistan