Misoprostol in the Treatment of Postpartum Hemorrhage

March 17, 2009 updated by: Gynuity Health Projects

Misoprostol in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals

Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

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
      • Karachi, Pakistan
        • Aga Khan University Hospital
      • Karachi, Pakistan
        • The Aga Khan Health Services

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:

  • All women delivering vaginally with clinically diagnosed PPH requiring uterotonics

Exclusion Criteria:

  • Refusal to give consent for participation or if the woman is too distressed to give consent
  • Woman is not entitled to give informed consent (e.g. minors without a guardian)
  • Woman who had a caesarean section
  • Delivery is regarded as abortion (gestational age < 28 weeks)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol
three tablets of active misoprostol (600 mcg) given sublingually
Drug: Misoprostol
600 mcg of sublingual misoprostol
Placebo Comparator: Placebo
three tablets resembling misoprostol given sublingually
Drug: Misoprostol
600 mcg of sublingual misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood loss greater than or equal to 500 mls after enrolment
Time Frame: Blood loss measured for minimum of 1 hour or until active bleeding ceased
Blood loss measured for minimum of 1 hour or until active bleeding ceased

Secondary Outcome Measures

Outcome Measure
Time Frame
Average blood loss
Time Frame: Blood loss measured for minimum of one hour or until active bleeding ceased
Blood loss measured for minimum of one hour or until active bleeding ceased
Clinical complications (need for transfusion, hysterectomy)
Time Frame: After delivery and prior to hospital discharge
After delivery and prior to hospital discharge
Pre-delivery and post-delivery hemoglobin measures
Time Frame: Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery
Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery
Side effects
Time Frame: observed or reported following study treatment and prior to discharge
observed or reported following study treatment and prior to discharge

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

  • Principal Investigator: Nadeem F Zuberi, MD, Aga Khan University Hospital, Karachi

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

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

December 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 29, 2005

First Submitted That Met QC Criteria

June 29, 2005

First Posted (Estimate)

June 30, 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

  • 2.4.2

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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