Misoprostol for Preventing Postpartum Hemorrhage

May 26, 2008 updated by: Gynuity Health Projects
This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Ibadan, Nigeria
        • University College Hospital
  • South Africa
      • Johannesburg, South Africa
        • Tembisa Hospital
      • Nelspruit, South Africa
        • Rob Ferreira Hospital
      • Port Elizabeth, South Africa
        • Dora Nginza Hospital
  • Uganda
      • Kampala, Uganda
        • Mulago Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who have given birth to 1 or more live-born infants (para 1 or more)
  • Vaginal delivery

Exclusion Criteria:

  • Refusal or inability to give informed consent
  • Delivery regarded as abortion according to local gestational age limits
  • Inability to take misoprostol sublingually
  • Cesarean section
  • Assisted vaginal delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
placebo resembling misoprostol
Drug: placebo
placebo resembling misoprosotl
Experimental: 2
misoprostol
Drug: misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Blood loss =>500 mls within one hour after enrollment

Secondary Outcome Measures

Outcome Measure
Side effects
Blood transfusion
Blood loss =>1000 mls within one hour after enrollment
Mean blood loss after enrollment
Hemoglobin level <8 g/dL 24 hours after delivery
Maternal morbidity and mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Collaborators

University of Witwatersrand, South Africa
Effective Care Research Unit
Family Care International

Investigators

  • Study Director: Lindeka Mangesi, Effective Care Research Unit, East London Hospital Complex, South Africa
  • Principal Investigator: G. J. Hofmeyr, MD, Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

July 26, 2005

First Submitted That Met QC Criteria

July 26, 2005

First Posted (Estimate)

July 28, 2005

Study Record Updates

Last Update Posted (Estimate)

May 28, 2008

Last Update Submitted That Met QC Criteria

May 26, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.4.5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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