NCT01485562

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Postpartum Haemorrhage

Interventions

Type	Name	Description
DRUG	Misoprostol	4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth
OTHER	placebo	4 tablets, administered sublingually if the woman experiences a PPH

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-12-05
• Last updated: 2016-03-10

Locations

1 site across 1 country: Pakistan