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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,586
- Locations
- 1
- Primary Endpoint
- postpartum hemorrhage-1
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •home delivery
- •presence of Community Health Officer at time of delivery
Exclusion Criteria
- Not provided
Arms & Interventions
Oxytocin in Uniject
Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby
Intervention: Oxytocin in Uniject (Other)
PPH Treatment Only
Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject
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)