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Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt

NCT02226588 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2827

Last updated 2016-02-15

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Misoprostol

Sponsors & Collaborators

  • Ministry of Health and Population, Egypt

    collaborator OTHER_GOV

  • University of Alexandria

    collaborator OTHER

  • El Galaa Teaching Hospital

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Nevine Hassanein, MD · Consultant

  • Emad Darwish, MD · Alexandria University

  • Mohamed Cherine, MD · El Galaa Teaching Hospital

  • Rasha Dabash, MPH · Gynuity Health Projects

  • Holly Anger, MPH · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02226588 on ClinicalTrials.gov