Trial | NCT01619072  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    82
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.
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.
Study Started
Nov 30
2012
Primary Completion
Oct 31
2013
Study Completion
Oct 31
2013
Last Update
Nov 25
2013
Estimate

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)

Misoprostol Active Comparator

800 mcg sublingual misoprostol + referral to higher level care

Placebo Placebo Comparator

Placebo + referral to higher level care

Criteria 

Inclusion Criteria:

women delivering with provider from participating primary health unit (PHU)
willing and able to give informed consent
vaginal delivery

Exclusion Criteria:

women too advanced into active labor to provide informed consent
known allergy to misoprostol and/or other prostaglandin
women presenting with pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, antepartum hemorrhage, previous complication in the third trimester (should be referred to higher level care for delivery)
No Results Posted