Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt
Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in El Beheira Governorate, Egypt
1 other identifier
interventional
2,827
1 country
2
Brief Summary
The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
August 27, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFebruary 15, 2016
February 1, 2016
1.3 years
August 25, 2014
February 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Mean drop in pre- to post-delivery hemoglobin level
Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.
Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.
Secondary Outcomes (7)
Proportion of women transferred to higher level care
Following delivery to postpartum visit (2 to 4 days after delivery)
Proportion of women diagnosed with PPH
After delivery of the baby up to 24 hours postpartum
Proportion of women receiving additional interventions for PPH
Following delivery to postpartum visit (2 to 4 days after delivery)
Proportion of women who experience side effects
From time of delivery to 2 hours postpartum
Proportion of women who find the intervention acceptable
Measured at postpartum visit (2 to 4 days after delivery)
- +2 more secondary outcomes
Study Arms (2)
Secondary prevention
EXPERIMENTALSingle sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment
Universal prophylaxis
ACTIVE COMPARATORSingle oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby
Interventions
Eligibility Criteria
You may qualify if:
- Willing and able to give informed consent
- Vaginal delivery
- Agrees to participate in follow-up interview
- Agrees to have pre- and post-hemoglobin taken
- Delivery at woman's home or at the primary health unit (PHU)
You may not qualify if:
- Too advanced into active labor to provide consent
- Known allergy to misoprostol and/or other prostaglandin
- Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynuity Health Projectslead
- Ministry of Health and Population, Egyptcollaborator
- University of Alexandriacollaborator
- El Galaa Teaching Hospitalcollaborator
Study Sites (2)
Primary Health Care Units
Damanhur, El Beheira, Egypt
Primary Health Care Units
Kafr El Dawar, El Beheira, Egypt
Related Publications (1)
Anger HA, Dabash R, Hassanein N, Darwish E, Ramadan MC, Nawar M, Charles D, Breebaart M, Winikoff B. A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt. BMC Pregnancy Childbirth. 2020 May 24;20(1):317. doi: 10.1186/s12884-020-03008-5.
PMID: 32448257DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nevine Hassanein, MD
Consultant
- PRINCIPAL INVESTIGATOR
Emad Darwish, MD
Alexandria University
- PRINCIPAL INVESTIGATOR
Mohamed Cherine, MD
El Galaa Teaching Hospital
- PRINCIPAL INVESTIGATOR
Rasha Dabash, MPH
Gynuity Health Projects
- PRINCIPAL INVESTIGATOR
Holly Anger, MPH
Gynuity Health Projects
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2014
First Posted
August 27, 2014
Study Start
October 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
February 15, 2016
Record last verified: 2016-02