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

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Other: Oxytocin in Uniject

• Registration Number: NCT01108289
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-02
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Study Start: 2011-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1586

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
postpartum hemorrhage-1	after delivery of baby	blood loss \>=500 ml after delivery of the baby, as measured through plastic calibrated drape
postpartum hemorrhage-2	after delivery of the baby	blood loss \>=500ml OR treatment dose of oxytocin provided
postpartum hemorrhage-3	after delivery of the baby	blood loss \>=500ml OR treatment dose of oxytocin provided OR referral for bleeding

Secondary Outcome Measures

Name	Time	Method
Oxytocin use before delivery	labor and delivery	the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby
stillbirth	labor/delivery	stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth
neonatal death	first month of life	neonatal death is defined as death of a live born baby prior to completion of 28 days
need for neonatal resuscitation	0-6 hours after birth

Trial Locations

Locations (1)

Kintampo Health Research Center; 🇬🇭 Kintampo, Brong Ahafo, Ghana