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

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Other: Misoprostol + referral; Other: Placebo + referral

• Registration Number: NCT01619072
• Lead Sponsor: Gynuity Health Projects

Brief 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.

Study Timeline

• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-14
• Study Start: 2012-11
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol + referral	800 mcg sublingual misoprostol + referral to higher level care
Placebo	Placebo + referral	Placebo + referral to higher level care

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery.	Before delivery (at onset of labor), after delivery (2 to 4 days after delivery)	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of women transferred to higher level care	Within 2 to 4 days after delivery	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 for whom intervention was correctly administered	Within 1 hour of PPH diagnosis	Proportion of women for whom treatment was administered as described in protocol (referral initiated and tablets administered to woman after PPH diagnosis made)
Cost-effectiveness	Within 2 to 4 days after delivery	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 receiving additional interventions to treat PPH	Within 2 to 4 days after delivery	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	Within 24 hours of delivery	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.

Trial Locations

Locations (1)

Prinary Health Units; 🇪🇬 Etay El Barood and Kafr El Dawar districts, El Beheira governorate, Egypt