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

NCT01108289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1586

Last updated 2013-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Postpartum Hemorrhage

Interventions

OTHER

Oxytocin in Uniject

10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Sponsors & Collaborators

  • Kintampo Health Research Centre, Ghana

    collaborator OTHER

  • PATH

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Cynthia Stanton, PhD · Johns Hopkins Bloomberg School of Public Health

  • Sam Newton, MD, PhD · Kintampo Health Research Center, Kintampo, Ghana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Ghana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01108289 on ClinicalTrials.gov