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PATH withdrew IRB approval
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| Name | Class |
|---|---|
| Jawaharlal Nehru Medical College Women's and Children's Health Research Unit | UNKNOWN |
| PATH | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
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This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPH Treatment only | No Intervention | Auxilliary nurse midwives will be able to treat for PPH only, not provide Oxytocin in Uniject | |
| Oxytocin in Uniject | Experimental | Auxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery |
|
| 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 | blood loss >=500 ml after delivery of the baby, as measured through a plastic calibrated drape. | after delivery of 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 and before birth of the baby |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Stanton, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Shivaprasad Goudar, MD | JN Medical College, Belgaum, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jawaharlal Nehru Medical College Women's and Children's Health Research Unit | Belagavi | Karnataka | India |
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| pregnancy |
| neonatal death | neonatal death is defined as death of a live born infant prior to completion of 28 days | first month of life |
| need for neonatal resuscitation | 0-6 hours after birth |
| 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 |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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