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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:
Johns Hopkins Bloomberg School of Public Health
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
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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 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:
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 ]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 ]blood loss >=500ml OR treatment dose of oxytocin provided
- 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:
- 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
- stillbirth [ Time Frame: labor/delivery ]stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth
- 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
- need for neonatal resuscitation [ Time Frame: 0-6 hours after birth ]
Other Outcome Measures:
- Postpartum Hemorrhage >=1000ml [ Time Frame: after delivery of the baby ]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) |
| 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:
Contacts and Locations
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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
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 |
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 June 22, 2017