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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108289
• Other study ID #: GAT.1429-07882-1
• Status: Completed
• Phase: N/A
• First received: April 2, 2010
• Last updated: July 1, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGhana: Committee on Human Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1586
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

• home delivery

• presence of Community Health Officer at time of delivery

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Other:
• Oxytocin in Uniject
10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Locations

Country	Name	City	State
Ghana	Kintampo Health Research Center	Kintampo	Brong Ahafo

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Bill and Melinda Gates Foundation, Kintampo Health Research Centre, Ghana, PATH

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postpartum Hemorrhage >=1000ml	1000ml or more blood is observed in the collection drape	after delivery of the baby	No
Primary	postpartum hemorrhage-1	blood loss >=500 ml after delivery of the baby, as measured through plastic calibrated drape	after delivery of baby	No
Primary	postpartum hemorrhage-2	blood loss >=500ml OR treatment dose of oxytocin provided	after delivery of the baby	No
Primary	postpartum hemorrhage-3	blood loss >=500ml OR treatment dose of oxytocin provided OR referral for bleeding	after delivery of the baby	No
Secondary	Oxytocin use before delivery	the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby	labor and delivery	Yes
Secondary	stillbirth	stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth	labor/delivery	Yes
Secondary	neonatal death	neonatal death is defined as death of a live born baby prior to completion of 28 days	first month of life	Yes
Secondary	need for neonatal resuscitation		0-6 hours after birth	Yes