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

NCT01108302 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-01-09

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

OTHER

Oxytocin in Uniject

10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Sponsors & Collaborators

  • Jawaharlal Nehru Medical College Women's and Children's Health Research Unit

    collaborator UNKNOWN

  • PATH

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Cynthia Stanton, PhD · Johns Hopkins Bloomberg School of Public Health

  • Shivaprasad Goudar, MD · JN Medical College, Belgaum, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01108302 on ClinicalTrials.gov