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

Arm | Intervention/treatment |
---|---|
Experimental: Oxytocin in Uniject
Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby
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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
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- 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
- 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 ]
- Postpartum Hemorrhage >=1000ml [ Time Frame: after delivery of the baby ]1000ml or more blood is observed in the collection drape

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Ages Eligible for Study: | 15 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- home delivery
- presence of Community Health Officer at time of delivery
Exclusion Criteria:
- None

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
Ghana | |
Kintampo Health Research Center | |
Kintampo, Brong Ahafo, Ghana |
Principal Investigator: | Cynthia Stanton, PhD | Johns Hopkins Bloomberg School of Public Health | |
Principal Investigator: | Sam Newton, MD, PhD | Kintampo Health Research Center, Kintampo, Ghana |
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 |
hemorrhage uterotonic oxytocin blood loss |
community Ghana randomized trial |
Postpartum Hemorrhage Hemorrhage Pathologic Processes Obstetric Labor Complications Pregnancy Complications Puerperal Disorders |
Uterine Hemorrhage Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |