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

NCT ID: NCT01487278

Last Updated: 2014-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Misoprostol

600 mcg oral misoprostol administered during the third stage of labor

Group Type EXPERIMENTAL

misprostol

Intervention Type DRUG

600 mcg misoprostol oral

UnijectTM

10 IU oxytocin delivered IM with UnijectTM during he third stage of labor

Group Type EXPERIMENTAL

UnijectTM

Intervention Type DEVICE

10 IU oxytocin delivered intramuscularly with UnijectTM

Interventions

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misprostol

600 mcg misoprostol oral

Intervention Type DRUG

UnijectTM

10 IU oxytocin delivered intramuscularly with UnijectTM

Intervention Type DEVICE

Other Intervention Names

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Cytotec

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Aga Khan Foundation

OTHER

Sponsor Role collaborator

Guttmacher Institute

OTHER

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayisha R Diop, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Laura J Frye, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Yacouba Kone, M.D

Role: PRINCIPAL_INVESTIGATOR

The Aga Khan Foundation

Locations

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Villages in Mopti

Mopti, , Mali

Site Status

Countries

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Mali

Other Identifiers

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2.4.8

Identifier Type: -

Identifier Source: org_study_id

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