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

January 6, 2012 updated by: Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Bill and Melinda Gates Foundation
PATH
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit

Investigators

  • Principal Investigator: Cynthia Stanton, PhD, Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Shivaprasad Goudar, MD, JN Medical College, Belgaum, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

April 2, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

January 9, 2012

Last Update Submitted That Met QC Criteria

January 6, 2012

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAT.1429-07882-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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