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

Not Applicable

Withdrawn

• Conditions: Postpartum Hemorrhage
• Interventions: Other: Oxytocin in Uniject

• Registration Number: NCT01108302
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-02
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Study Start: 2011-09
• Status Verified: 2011-12
• Last Update Submitted: 2012-01-06
• Last Update Posted: 2012-01-09
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin in Uniject	Oxytocin in Uniject	Auxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery

Primary Outcome Measures

Name	Time	Method
postpartum hemorrhage	after delivery of baby	blood loss \>=500 ml after delivery of the baby, as measured through a plastic calibrated drape.

Secondary Outcome Measures

Name	Time	Method
Oxytocin use before delivery	labor and delivery	the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby
stillbirth	pregnancy	stillbirth is defined as death of a fetus after 28 weeks of gestation and before birth of the baby
neonatal death	first month of life	neonatal death is defined as death of a live born infant prior to completion of 28 days
need for neonatal resuscitation	0-6 hours after birth

Trial Locations

Locations (1)

Jawaharlal Nehru Medical College Women's and Children's Health Research Unit; 🇮🇳 Belgaum, Karnataka, India