Misoprostol for Treatment of Postpartum Hemorrhage at Community-level Births in Egypt
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.
Other: Misoprostol + referral
Other: Placebo + referral
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery. [ Time Frame: Before delivery (at onset of labor), after delivery (2 to 4 days after delivery) ] [ Designated as safety issue: No ]Proportion of women with a change in hemoglobin of >2 g/dL pre- to post-delivery, as measured by the HemoCue machine at both time points.
- Proportion of women transferred to higher level care [ Time Frame: Within 2 to 4 days after delivery ] [ Designated as safety issue: No ]Proportion of women transferred to higher level care will be compared. The condition of the woman at time of transfer and arrival will also be noted.
- Proportion of women receiving additional interventions to treat PPH [ Time Frame: Within 2 to 4 days after delivery ] [ Designated as safety issue: Yes ]Proportion of women who receive any additional intervention (e.g. uterotonics, manual removal of placental fragments, bimanual compression, IV fluids given, surgical procedures, blood transfusion, etc.) provided either at deliver site or upon transfer to district hospital.
- Proportion of women with side effects [ Time Frame: Within 24 hours of delivery ] [ Designated as safety issue: Yes ]Proportion of women with observed side effects (including shivering/chills, fever, nausea, diarrhea or fainting). Reported severity of side effects (classified by provider as "mild, "moderate," "severe," ), duration of side effects and proportion of of women receiving additional care to manage side effects will also be assessed.
- Cost-effectiveness [ Time Frame: Within 2 to 4 days after delivery ] [ Designated as safety issue: No ]A cost-effectiveness analysis will be done to compare the two treatment arms. The analysis will factor in the cost of materials used, procedures/interventions performed, transfers, and training of providers.
- Proportion of women for whom intervention was correctly administered [ Time Frame: Within 1 hour of PPH diagnosis ] [ Designated as safety issue: Yes ]Proportion of women for whom treatment was administered as described in protocol (referral initiated and tablets administered to woman after PPH diagnosis made)
|Study Start Date:||November 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Misoprostol
800 mcg sublingual misoprostol + referral to higher level care
Other: Misoprostol + referral
800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)
Placebo Comparator: Placebo
Placebo + referral to higher level care
Other: Placebo + referral
Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619072
|Prinary Health Units|
|Etay El Barood and Kafr El Dawar districts, El Beheira governorate, Egypt|
|Principal Investigator:||Mohamed Cherine Ramadan, MD||El Galaa Teaching Hospital|
|Principal Investigator:||Nevine Hassanein, MD||Consultant|
|Principal Investigator:||Emad Darwish, MD||Alexandria University Faculy of Medicine|
|Principal Investigator:||Emad Ezzat, MD||Ministry of Health and Population|
|Principal Investigator:||Rasha Dabash, MPH||Gynuity Health Projects|