Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal

NCT ID: NCT01713153

Last Updated: 2016-02-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

1365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-01-31

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, 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

Misoprostol

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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Misoprostol

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 Misoclear

Eligibility Criteria

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Inclusion Criteria

* women delivering in community health centers (case de sante) with a trained study provider (matrone) 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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ChildFund International

UNKNOWN

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Health huts in the district of Thiadiaye and Kolda

Thiadiay and Kolda, Thiadiaye and Kolda, Senegal

Site Status

Countries

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Senegal

References

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Diop A, Daff B, Sow M, Blum J, Diagne M, Sloan NL, Winikoff B. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial. Lancet Glob Health. 2016 Jan;4(1):e37-44. doi: 10.1016/S2214-109X(15)00219-3.

Reference Type DERIVED
PMID: 26718808 (View on PubMed)

Other Identifiers

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2.4.9

Identifier Type: -

Identifier Source: org_study_id

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