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

This study has been completed.
Sponsor:
Collaborators:
Kintampo Health Research Centre, Ghana
PATH
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: July 1, 2013
Last verified: July 2013
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:

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 ]

Other Outcome Measures:
  • Postpartum Hemorrhage >=1000ml [ Time Frame: after delivery of the baby ] [ Designated as safety issue: No ]
    1000ml or more blood is observed in the collection drape
Enrollment: 1586
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 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   (Child, Adult)
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108289

Locations
Ghana
Kintampo Health Research Center
Kintampo, Brong Ahafo, Ghana
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Kintampo Health Research Centre, Ghana
PATH
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

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: July 1, 2013
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
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
 Uterine Hemorrhage
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016