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

NCT01619072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2013-11-25

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

OTHER

Misoprostol + referral

800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)

OTHER

Placebo + referral

Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)

Sponsors & Collaborators

  • Ministry of Health and Population, Egypt

    collaborator OTHER_GOV

  • El Galaa Teaching Hospital

    collaborator OTHER

  • Alexandria University

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Mohamed Cherine Ramadan, MD · El Galaa Teaching Hospital

  • Nevine Hassanein, MD · Consultant

  • Emad Darwish, MD · Alexandria University Faculy of Medicine

  • Emad Ezzat, MD · Ministry of health and population

  • Rasha Dabash, MPH · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Egypt

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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 NCT01619072 on ClinicalTrials.gov