Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

March 17, 2009 updated by: Gynuity Health Projects

A Placebo-Controlled Randomized Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan

This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1600

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

  • Pakistan
    • Chitral District
      • Chitral, Chitral District, Pakistan
        • Home delivery setting

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women in general good health, home delivery
  • Must live in one of 78 study villages

Exclusion Criteria:

  • Hypertension
  • Non-cephalic presentation
  • Polyhydramnios
  • Previous cesarean section
  • Suspected multiple pregnancy
  • Suspected still birth
  • Antepartum hemorrhage
  • Previous complication in 3rd trimester
  • Anemia of <8 g/dl

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postpartum hemorrhage (blood loss >or= 500 mL)
Time Frame: Measured at 1 hour postpartum or until active bleeding has stopped
Measured at 1 hour postpartum or until active bleeding has stopped
Drop in hemoglobin > 2 g/dL from pre to post-delivery
Time Frame: Hemoblobin (Hb) level measured 3-5 days after delivery
Hemoblobin (Hb) level measured 3-5 days after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL)
Time Frame: Blood loss measured at 1 hr postpartum or until active bleeding stopped
Blood loss measured at 1 hr postpartum or until active bleeding stopped
Mean blood loss
Time Frame: blood loss measured at 1 hr postpartum or until active bleeding stopped
blood loss measured at 1 hr postpartum or until active bleeding stopped
Side effects experienced among recently delivered mothers
Time Frame: Interviews conducted 1 day post-delivery
Interviews conducted 1 day post-delivery
Anemia (<9 g/dL and <11 g/dL)
Time Frame: Postpartum hemoglobin assessed 3 days post-delivery
Postpartum hemoglobin assessed 3 days post-delivery

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Collaborators

Aga Khan University
Aga Khan Health Services
The Aga Khan Foundation
Family Care International

Investigators

  • Study Director: Jennifer Blum, MPH, Gynuity Health Projects
  • Principal Investigator: Gijs Walraven, MD, Aga Khan Health Services
  • Principal Investigator: Juanita Hatcher, PhD, Aga Khan University
  • Study Director: Naushaba Mobeen, MD, Aga Khan University
  • Study Director: Zafar Ahmad, MD, Aga Khan Health Services
  • Study Director: Nadeem Zuberi, MD, Aga Khan University

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.

Helpful Links

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

July 1, 2005

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 7, 2005

First Submitted That Met QC Criteria

July 7, 2005

First Posted (Estimate)

July 15, 2005

Study Record Updates

Last Update Posted (Estimate)

March 19, 2009

Last Update Submitted That Met QC Criteria

March 17, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.4.4

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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