Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

January 8, 2014 updated by: Gynuity Health Projects

Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in UnijectTM in Mali

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

Study Type

Interventional

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

  • Mali
      • Mopti, Mali
        • Villages in Mopti

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:

  • women delivering at home with a trained study provider who are able to provide informed consent

Exclusion Criteria:

  • women with known contraindications to prostaglandins

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol
600 mcg oral misoprostol administered during the third stage of labor
Drug: misprostol
600 mcg misoprostol oral
Other Names:
  • Cytotec
Experimental: UnijectTM
10 IU oxytocin delivered IM with UnijectTM during he third stage of labor
Device: UnijectTM
10 IU oxytocin delivered intramuscularly with UnijectTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in hemoglobin
Time Frame: during 3rd trimester and 1-3 days postpartum
To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.
during 3rd trimester and 1-3 days postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence and management of side effects
Time Frame: 1 hour postpartum
nausea, vomiting, diarrhea, shivering, fever
1 hour postpartum
correct timing of drug administration
Time Frame: collected immediately following birth, verified 1-3 days postpartum
administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta
collected immediately following birth, verified 1-3 days postpartum
change in hemoglobin ≥ 2 g/dL
Time Frame: during third trimester and 1-3 days postpartum
during third trimester and 1-3 days postpartum
additional interventions
Time Frame: during birth and 1-3 days postpartum
use of additional uterotonics, manual removal of placental fragments, etc
during birth and 1-3 days postpartum
referrals
Time Frame: 1-3 days postpartum
referral requested, transfers carried out, reasons for incomplete referrals/transfers
1-3 days postpartum
acceptability
Time Frame: 1-3 days postpartum
acceptability according to woman of study medication, care received, side effects experienced
1-3 days postpartum

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Collaborators

The Aga Khan Foundation
Guttmacher Institute

Investigators

  • Principal Investigator: Ayisha R Diop, MPH, Gynuity Health Projects
  • Principal Investigator: Laura J Frye, MPH, Gynuity Health Projects
  • Principal Investigator: Yacouba Kone, M.D, The Aga Khan Foundation

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 Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.4.8

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.

Clinical Trials on Postpartum Hemorrhage

Clinical Trials on misprostol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe