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

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

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 Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Other: Oxytocin in Uniject

• Study Type: Interventional
• Enrollment (Actual): 1586
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Brong Ahafo
    • Kintampo, Brong Ahafo, Ghana
      • Kintampo Health Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum Hemorrhage >=1000ml	1000ml or more blood is observed in the collection drape	after delivery of the baby

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Bill and Melinda Gates Foundation; PATH; Kintampo Health Research Centre, Ghana
• Investigators: Principal Investigator: Cynthia Stanton, PhD, Johns Hopkins Bloomberg School of Public Health; Principal Investigator: Sam Newton, MD, PhD, Kintampo Health Research Center, Kintampo, Ghana

Publications and helpful links

General Publications

• Stanton CK, Newton S, Mullany LC, Cofie P, Tawiah Agyemang C, Adiibokah E, Amenga-Etego S, Darcy N, Khan S, Armbruster D, Gyapong J, Owusu-Agyei S. Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial. PLoS Med. 2013 Oct;10(10):e1001524. doi: 10.1371/journal.pmed.1001524. Epub 2013 Oct 1.
• Stanton CK, Newton S, Mullany LC, Cofie P, Agyemang CT, Adiibokah E, Darcy N, Khan S, Levisay A, Gyapong J, Armbruster D, Owusu-Agyei S. Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject by peripheral health care providers at home births: design of a community-based cluster-randomized trial. BMC Pregnancy Childbirth. 2012 Jun 7;12:42. doi: 10.1186/1471-2393-12-42.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 2, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 21, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2013
• Last Update Submitted That Met QC Criteria: July 1, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: randomized trial; blood loss; oxytocin; hemorrhage; community; Ghana; uterotonic
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: GAT.1429-07882-1