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

This study is currently recruiting participants.
Verified December 2011 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborators:
Kintampo Health Research Centre, Ghana
Program for Appropriate Technology in Health
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01108289
First received: April 2, 2010
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
 Other: Oxytocin in Uniject

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

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care
Drug Information available for: Oxytocin
U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • postpartum hemorrhage-1 [ Time Frame: after delivery of baby ] [ Designated as safety issue: No ]
    blood loss >=500 ml after delivery of the baby, as measured through plastic calibrated drape

  • postpartum hemorrhage-2 [ Time Frame: after delivery of the baby ] [ Designated as safety issue: No ]
    blood loss >=500ml OR treatment dose of oxytocin provided

  • postpartum hemorrhage-3 [ Time Frame: after delivery of the baby ] [ Designated as safety issue: No ]
    blood loss >=500ml OR treatment dose of oxytocin provided OR referral for bleeding


Secondary Outcome Measures:
  • Oxytocin use before delivery [ Time Frame: labor and delivery ] [ Designated as safety issue: Yes ]
    the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby

  • stillbirth [ Time Frame: labor/delivery ] [ Designated as safety issue: Yes ]
    stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth

  • neonatal death [ Time Frame: first month of life ] [ Designated as safety issue: Yes ]
    neonatal death is defined as death of a live born baby prior to completion of 28 days

  • need for neonatal resuscitation [ Time Frame: 0-6 hours after birth ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
Study Start Date: April 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: uterotonic, pitocin
No Intervention: PPH Treatment Only
Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108289

Contacts
Contact: Cynthia Stanton, PhD 301 741 5871 cstanton@jhsph.edu
Contact: Luke C Mullany, PhD 410-502-2626 lmullany@jhsph.edu

Locations
Ghana
Kintampo Health Research Center Recruiting
Kintampo, Brong Ahafo, Ghana
Contact: Sam Newton, MD, PhD         sam.newton@kintampo-hrc.org    
Contact: Cynthia Stanton, PhD     301 741 5871     cstanton@jhsph.edu    
Principal Investigator: Sam Newton, MD, PhD            
Principal Investigator: Cynthia Stanton, PhD            
Sub-Investigator: Luke C Mullany, PhD, MHS            
Sub-Investigator: Seth Owusu-Agyei, PhD            
Sub-Investigator: Patience Cofie, MSc            
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Kintampo Health Research Centre, Ghana
Program for Appropriate Technology in Health
Bill and Melinda Gates Foundation
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
  More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01108289     History of Changes
Other Study ID Numbers: GAT.1429-07882-1
Study First Received: April 2, 2010
Last Updated: December 16, 2011
Health Authority: United States: Institutional Review Board
Ghana: Committee on Human Research

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
hemorrhage
uterotonic
oxytocin
blood loss
 community
Ghana
randomized trial

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
 Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013