Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India

Study Overview
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Brief Summary
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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.

Official Title
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Assessing the Effectiveness, Safety and Feasibility of Expanding Use of Oxytocin in Uniject™ by Auxiliary Nurse Midwives to Prevent Postpartum Hemorrhage: A Community-based Cluster Randomized Trial in Bagalkot, India

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Other: Oxytocin in Uniject


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gestational age >=28 wks at enrollment anticipate spontaneous vaginal delivery hemoglobin >=8 gm/dl delivery at home, sub-center, or primary health center delivery attended by Auxilliary Nurse Midwife Exclusion Criteria: previous caesarean-section scheduled for caesarean-section antepartum bleeding during current pregnancy blood pressure >140mm of Hg systolic and >90mm of Hg diastolic in active labor at time of recruitment high risk medical conditions (diabetes, cardiac ailments, seizures, placenta previa, anticipated breech delivery
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: PPH Treatment only<br>Auxilliary nurse midwives will be able to treat for PPH only, not provide Oxytocin in Uniject | |
| Experimental: Oxytocin in Uniject<br>Auxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery | Other: Oxytocin in Uniject<br>* 10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby<br>* Other names: Pitocin, Syntocinon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uterotonic, oxytocin, randomized trial, India, community, hemorrhage