Clinical trial NCT01108289: Effect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: hemorrhage
uterotonic
oxytocin
blood loss
community
Ghana
randomized trial
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Kintampo Health Research Centre, Ghana
name: PATH
name: Bill and Melinda Gates Foundation
First posted: 2010-04-21
Enrollment: 1586
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: postpartum hemorrhage-1
timeFrame: after delivery of baby
measure: postpartum hemorrhage-2
timeFrame: after delivery of the baby
measure: postpartum hemorrhage-3
timeFrame: after delivery of the baby
Secondary outcomes:
measure: Oxytocin use before delivery
timeFrame: labor and delivery
measure: stillbirth
timeFrame: labor/delivery
measure: neonatal death
timeFrame: first month of life
measure: need for neonatal resuscitation
timeFrame: 0-6 hours after birth
Other outcomes:
measure: Postpartum Hemorrhage >=1000ml
timeFrame: after delivery of the baby
Locations:
city: Kintampo
country: Ghana
facility: Kintampo Health Research Center
state: Brong Ahafo
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Cynthia Stanton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kintampo Health Research Center, Kintampo, Ghana
name: Sam Newton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.