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Clinical Trials/NCT01108289
NCT01108289
Completed
Not Applicable

The Oxytocin Initiative: Determining the Effect of Prophylactic Administration of Oxytocin in Uniject™ by a Community Health Officer on Postpartum Hemorrhage at Home Births in Four Districts in Ghana

Johns Hopkins Bloomberg School of Public Health1 site in 1 country1,586 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Hemorrhage
Sponsor
Johns Hopkins Bloomberg School of Public Health
Enrollment
1586
Locations
1
Primary Endpoint
postpartum hemorrhage-1
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
December 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

postpartum hemorrhage-1

Time Frame: after delivery of baby

blood loss \>=500 ml after delivery of the baby, as measured through plastic calibrated drape

postpartum hemorrhage-2

Time Frame: after delivery of the baby

blood loss \>=500ml OR treatment dose of oxytocin provided

postpartum hemorrhage-3

Time Frame: after delivery of the baby

blood loss \>=500ml OR treatment dose of oxytocin provided OR referral for bleeding

Secondary Outcomes

  • Oxytocin use before delivery(labor and delivery)
  • stillbirth(labor/delivery)
  • neonatal death(first month of life)
  • need for neonatal resuscitation(0-6 hours after birth)

Study Sites (1)

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