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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Other: Oxytocin in Uniject

Study type: Interventional

Funder types: Other

Identifiers

NCT01108289

GAT.1429-07882-1

Details and patient eligibility

About

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.

Enrollment: 1,586 patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,586 participants in 2 patient groups

Oxytocin in Uniject

Experimental group

Description:

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

Treatment:

Other: Oxytocin in Uniject

PPH Treatment Only

No Intervention group

Description:

Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject