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

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ClinicalTrials.gov Identifier: NCT01108289
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : July 2, 2013
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Other: Oxytocin in Uniject Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1586 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Oxytocin

Arms and Interventions
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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 Name: uterotonic, pitocin
No Intervention: PPH Treatment Only
Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject


Outcome Measures
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Primary Outcome Measures :
  1. postpartum hemorrhage-1 [ Time Frame: after delivery of baby ]
    blood loss >=500 ml after delivery of the baby, as measured through plastic calibrated drape

  2. postpartum hemorrhage-2 [ Time Frame: after delivery of the baby ]
    blood loss >=500ml OR treatment dose of oxytocin provided

  3. postpartum hemorrhage-3 [ Time Frame: after delivery of the baby ]
    blood loss >=500ml OR treatment dose of oxytocin provided OR referral for bleeding


Secondary Outcome Measures :
  1. Oxytocin use before delivery [ Time Frame: labor and delivery ]
    the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby

  2. stillbirth [ Time Frame: labor/delivery ]
    stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth

  3. neonatal death [ Time Frame: first month of life ]
    neonatal death is defined as death of a live born baby prior to completion of 28 days

  4. need for neonatal resuscitation [ Time Frame: 0-6 hours after birth ]

Other Outcome Measures:
  1. Postpartum Hemorrhage >=1000ml [ Time Frame: after delivery of the baby ]
    1000ml or more blood is observed in the collection drape


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108289


Locations
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01108289    
Other Study ID Numbers: GAT.1429-07882-1
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
hemorrhage
uterotonic
oxytocin
blood loss
 community
Ghana
randomized trial
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
 Uterine Hemorrhage
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs