Back to resultsEffect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Oxytocin in Uniject
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring hemorrhage, uterotonic, oxytocin, blood loss, community, Ghana, randomized trial
Eligibility Criteria
Inclusion Criteria:
- home delivery
- presence of Community Health Officer at time of delivery
Exclusion Criteria:
- None
Sites / Locations
- Kintampo Health Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oxytocin in Uniject
PPH Treatment Only
Arm Description
Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby
Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject
Outcomes
Primary Outcome Measures
postpartum hemorrhage-1
blood loss >=500 ml after delivery of the baby, as measured through plastic calibrated drape
postpartum hemorrhage-2
blood loss >=500ml OR treatment dose of oxytocin provided
postpartum hemorrhage-3
blood loss >=500ml OR treatment dose of oxytocin provided OR referral for bleeding
Secondary Outcome Measures
Oxytocin use before delivery
the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby
stillbirth
stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth
neonatal death
neonatal death is defined as death of a live born baby prior to completion of 28 days
need for neonatal resuscitation
Full Information
NCT ID
NCT01108289
First Posted
April 2, 2010
Last Updated
July 1, 2013
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Kintampo Health Research Centre, Ghana, PATH, Bill and Melinda Gates Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01108289
Brief Title
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
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Kintampo Health Research Centre, Ghana, PATH, Bill and Melinda Gates Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
hemorrhage, uterotonic, oxytocin, blood loss, community, Ghana, randomized trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1586 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin in Uniject
Arm Type
Experimental
Arm Description
Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby
Arm Title
PPH Treatment Only
Arm Type
No Intervention
Arm Description
Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject
Intervention Type
Other
Intervention Name(s)
Oxytocin in Uniject
Other Intervention Name(s)
uterotonic, pitocin
Intervention Description
10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
Primary Outcome Measure Information:
Title
postpartum hemorrhage-1
Description
blood loss >=500 ml after delivery of the baby, as measured through plastic calibrated drape
Time Frame
after delivery of baby
Title
postpartum hemorrhage-2
Description
blood loss >=500ml OR treatment dose of oxytocin provided
Time Frame
after delivery of the baby
Title
postpartum hemorrhage-3
Description
blood loss >=500ml OR treatment dose of oxytocin provided OR referral for bleeding
Time Frame
after delivery of the baby
Secondary Outcome Measure Information:
Title
Oxytocin use before delivery
Description
the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby
Time Frame
labor and delivery
Title
stillbirth
Description
stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth
Time Frame
labor/delivery
Title
neonatal death
Description
neonatal death is defined as death of a live born baby prior to completion of 28 days
Time Frame
first month of life
Title
need for neonatal resuscitation
Time Frame
0-6 hours after birth
Other Pre-specified Outcome Measures:
Title
Postpartum Hemorrhage >=1000ml
Description
1000ml or more blood is observed in the collection drape
Time Frame
after delivery of the baby
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
home delivery
presence of Community Health Officer at time of delivery
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Stanton, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sam Newton, MD, PhD
Organizational Affiliation
Kintampo Health Research Center, Kintampo, Ghana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kintampo Health Research Center
City
Kintampo
State/Province
Brong Ahafo
Country
Ghana
12. IPD Sharing Statement
Citations:
PubMed Identifier
24130463
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.
Results Reference
derived
PubMed Identifier
22676921
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.
Results Reference
derived
Learn more about this trial
Effect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana
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