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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Other: Misoprostol + referral; Other: Placebo + referral

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Beheira governorate
    • Etay El Barood and Kafr El Dawar districts, El Beheira governorate, Egypt
      • Prinary Health Units

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Alexandria University; Ministry of Health and Population, Egypt; El Galaa Teaching Hospital
• Investigators: Principal Investigator: Emad Darwish, MD, Alexandria University Faculy of Medicine; Principal Investigator: Emad Ezzat, MD, Ministry of health and population

Publications and helpful links

General Publications

• Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (ESTIMATE): June 14, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 21, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: treatment; postpartum hemorrhage; misoprostol; home births
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 3001