RCT of Misoprostol for Postpartum Hemorrhage in India

July 29, 2014 updated by: NICHD Global Network for Women's and Children's Health
Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite existing knowledge of ways to effectively treat postpartum hemorrhage (PPH), lack of resources in rural India has impeded improvement in rates of maternal mortality and morbidity. Most births take place at home, and local auxiliary nurse midwives are not trained or certified to administer injectable uterotonics. Reduction in postpartum hemorrhage may decrease other adverse maternal outcomes such as the need for additional uterotonic agents, blood transfusion, surgical intervention or death. The main hypothesis of the study is that misoprostol administered orally during the third stage of labor will significantly reduce the incidence of acute postpartum hemorrhage. The advantages of misoprostol are: that it is relatively inexpensive, is an oral preparation of 600 mcg with a long shelf life, and does not require refrigeration. One thousand six hundred women giving birth in selected sites in Belgaum District, Karnataka, India will be randomly assigned to misoprostol or placebo. The primary outcome is the incidence of acute postpartum hemorrhage; secondary outcomes include incidence of delayed postpartum hemorrhage and secondary infection; transport to higher-level facility; use of uterotonic agents; blood transfusion; and maternal mortality for 42 days. A nested case-control analysis of women who experience acute severe postpartum hemorrhage, compared to women who do not, will identify socioeconomic, behavioral, cultural, and systems factors associated with postpartum hemorrhage. For purposes of this study, acute PPH is defined as blood loss equal to or greater than 500 ml within 2 hours of delivery and acute severe PPH as blood loss equal to or greater than 1000 ml within 2 hours of delivery.

The sample size was based on a decrease of 50% PPH in the treated versus the control group; 20% rate of non-compliance, power of 96%, and a two-tailed type I error of 0.05

Study Type

Interventional

Enrollment (Anticipated)

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

  • India
    • Karnataka
      • Belgaum, Karnataka, India, 590 010
        • KLE Society's Jawaharlal Nehru Medical College

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:

  • Gestational age equal to or greater than 28 weeks pregnant
  • Planning to deliver at home or at a sub-center in the Belgaum District, Karnataka India
  • Anticipating a spontaneous vaginal delivery
  • Ability and willingness to provide informed consent

Exclusion Criteria:

  • Previous caesarian section
  • Scheduled for caesarian section
  • Hemoglobin level less than 8 Gms%
  • Episodes of antepartum bleeding during the current pregnancy
  • Blood pressure more than 140 mm of Hg systolic and 90 mm of Hg diastolic
  • In active labor and not previously screened, recruited, and consented
  • Absence of fetal heart sounds
  • Multiple pregnancy
  • Known history of bronchial asthma
  • Prior enrollment in this study during a previous pregnancy
  • History of complications (ante/postpartum hemorrhage/retained placenta/ acute inversion of uterus) during a previous pregnancy
  • High risk conditions including: diabetes, cardiac ailments, seizures, placenta previa or anticipated breech delivery.
  • Receiving injectable medicine at time of 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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery

Secondary Outcome Measures

Outcome Measure
Blood transfusion
Incidence of delayed postpartum hemorrhage and secondary infection (lower abdominal pain, fever and foul discharge)
Transport to higher-level medical facility
Use of uterotonic agents
Surgical intervention including curettage, vacuum aspiration for retained placental tissue or hysterectomy
Maternal mortality for 42 days

Collaborators and Investigators

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

Sponsor

NICHD Global Network for Women's and Children's Health

Collaborators

National Cancer Institute (NCI)
University of Missouri-Columbia
National Institute of Dental and Craniofacial Research (NIDCR)
Bill and Melinda Gates Foundation
National Center for Complementary and Integrative Health (NCCIH)
Fogarty International Center of the National Institute of Health
RTI International
Jawaharlal Nehru Medical College
Global Network for Women's and Children's Health Research

Investigators

  • Principal Investigator: Richard J Derman, M.D., University of Missouri-Columbia

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

September 1, 2002

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

November 17, 2004

First Submitted That Met QC Criteria

November 17, 2004

First Posted (Estimate)

November 18, 2004

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN 08
  • U01HD042372 (U.S. NIH Grant/Contract)

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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