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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01108302

Enrollment

Registered

2010-04-21

Start date

2011-09-30

Completion date

2013-06-30

Last updated

2012-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Keywords

uterotonic, oxytocin, randomized trial, India, community, hemorrhage

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.

Interventions

OTHEROxytocin in Uniject

10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026