NCT01619072

Misoprostol for Treatment of Postpartum Hemorrhage at Community-level Births in Egypt

A Randomized Controlled Community Study of the Effectiveness of Misoprostol for PPH Treatment at the Community Level (Home Births Attended by Primary Care Unit Staff) in Etay El Barood and Kafr El Dawar Districts (El Beheira Governorate), Egypt

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled community-based trial will assess the effectiveness of administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with standard of care for postpartum hemorrhage treatment at the community level, primarily home births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this setting is referral to a higher level health facility.

Detailed description

Hospital-based clinical trials have demonstrated misoprostol to be a safe and effective treatment option for postpartum hemorrhage (PPH). Additional research is needed to demonstrate how these findings translate into program effectiveness at lower levels of the health care system, including community home births, where access to skilled providers and treatment options are limited and misoprostol could potentially have the greatest impact on maternal health outcomes. This randomized controlled community treatment trial will assess the effectiveness of misoprostol with standard of care (i.e., referral to higher level care) vs. placebo with standard of care for PPH treatment at the community level, primarily home births attended by primary health care unit staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. This research will help guide decisions on how to introduce misoprostol into PPH care programs in different contexts such as primary care settings, including community-based home births.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
OTHER	Misoprostol + referral	800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)
OTHER	Placebo + referral	Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-06-14
• Last updated: 2013-11-25

Locations

1 site across 1 country: Egypt