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| Name | Class |
|---|---|
| Kintampo Health Research Centre, Ghana | OTHER |
| PATH | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin in Uniject | Experimental | Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby |
|
| PPH Treatment Only | No Intervention | Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin in Uniject | Other | 10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby |
|
| Measure | Description | Time Frame |
|---|---|---|
| postpartum hemorrhage-1 | blood loss >=500 ml after delivery of the baby, as measured through plastic calibrated drape | after delivery of baby |
| postpartum hemorrhage-2 | blood loss >=500ml OR treatment dose of oxytocin provided | after delivery of the baby |
| postpartum hemorrhage-3 | blood loss >=500ml OR treatment dose of oxytocin provided OR referral for bleeding | after delivery of the baby |
| Measure | Description | Time Frame |
|---|---|---|
| Oxytocin use before delivery | the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby | labor and delivery |
| stillbirth | stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum Hemorrhage >=1000ml | 1000ml or more blood is observed in the collection drape | after delivery of the baby |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Stanton, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Sam Newton, MD, PhD | Kintampo Health Research Center, Kintampo, Ghana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kintampo Health Research Center | Kintampo | Brong Ahafo | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24130463 | Derived | Stanton CK, Newton S, Mullany LC, Cofie P, Tawiah Agyemang C, Adiibokah E, Amenga-Etego S, Darcy N, Khan S, Armbruster D, Gyapong J, Owusu-Agyei S. Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial. PLoS Med. 2013 Oct;10(10):e1001524. doi: 10.1371/journal.pmed.1001524. Epub 2013 Oct 1. | |
| 22676921 |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| labor/delivery |
| neonatal death | neonatal death is defined as death of a live born baby prior to completion of 28 days | first month of life |
| need for neonatal resuscitation | 0-6 hours after birth |
| Derived |
| Stanton CK, Newton S, Mullany LC, Cofie P, Agyemang CT, Adiibokah E, Darcy N, Khan S, Levisay A, Gyapong J, Armbruster D, Owusu-Agyei S. Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject by peripheral health care providers at home births: design of a community-based cluster-randomized trial. BMC Pregnancy Childbirth. 2012 Jun 7;12:42. doi: 10.1186/1471-2393-12-42. |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |