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

Study Overview
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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.

Official Title
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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

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Other: Oxytocin in Uniject


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: home delivery presence of Community Health Officer at time of delivery Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin in Uniject<br>Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby | Other: Oxytocin in Uniject<br>* 10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby<br>* Other names: uterotonic, pitocin;|
| No Intervention: PPH Treatment Only<br>Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhage, uterotonic, oxytocin, blood loss, community, Ghana, randomized trial