Effect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana

NCT ID: NCT01108289

Last Updated: 2013-07-02

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

1586 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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This study is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO) at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.

Detailed Description

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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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Oxytocin in Uniject

Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby

Group Type EXPERIMENTAL

Oxytocin in Uniject

Intervention Type OTHER

10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

PPH Treatment Only

Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oxytocin in Uniject

10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Intervention Type OTHER

Other Intervention Names

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uterotonic, pitocin

Eligibility Criteria

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Inclusion Criteria

* home delivery
* presence of Community Health Officer at time of delivery

Exclusion Criteria

* None
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kintampo Health Research Centre, Ghana

OTHER

Sponsor Role collaborator

PATH

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia Stanton, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Sam Newton, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kintampo Health Research Center, Kintampo, Ghana

Locations

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Kintampo Health Research Center

Kintampo, Brong Ahafo, Ghana

Site Status

Countries

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Ghana

References

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Stanton CK, Newton S, Mullany LC, Cofie P, Tawiah Agyemang C, Adiibokah E, Amenga-Etego S, Darcy N, Khan S, Armbruster D, Gyapong J, Owusu-Agyei S. Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial. PLoS Med. 2013 Oct;10(10):e1001524. doi: 10.1371/journal.pmed.1001524. Epub 2013 Oct 1.

Reference Type DERIVED
PMID: 24130463 (View on PubMed)

Stanton CK, Newton S, Mullany LC, Cofie P, Agyemang CT, Adiibokah E, Darcy N, Khan S, Levisay A, Gyapong J, Armbruster D, Owusu-Agyei S. Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject by peripheral health care providers at home births: design of a community-based cluster-randomized trial. BMC Pregnancy Childbirth. 2012 Jun 7;12:42. doi: 10.1186/1471-2393-12-42.

Reference Type DERIVED
PMID: 22676921 (View on PubMed)

Other Identifiers

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GAT.1429-07882-1

Identifier Type: -

Identifier Source: org_study_id

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