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

This study has been withdrawn prior to enrollment.
(PATH withdrew IRB approval)
Sponsor:
Collaborators:
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
PATH
Bill and Melinda Gates Foundation
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01108302
First received: April 2, 2010
Last updated: January 6, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Other: Oxytocin in Uniject

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • postpartum hemorrhage [ Time Frame: after delivery of baby ] [ Designated as safety issue: No ]
    blood loss >=500 ml after delivery of the baby, as measured through a plastic calibrated drape.


Secondary Outcome Measures:
  • Oxytocin use before delivery [ Time Frame: labor and delivery ] [ Designated as safety issue: Yes ]
    the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby

  • stillbirth [ Time Frame: pregnancy ] [ Designated as safety issue: Yes ]
    stillbirth is defined as death of a fetus after 28 weeks of gestation and before birth of the baby

  • neonatal death [ Time Frame: first month of life ] [ Designated as safety issue: Yes ]
    neonatal death is defined as death of a live born infant prior to completion of 28 days

  • need for neonatal resuscitation [ Time Frame: 0-6 hours after birth ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Pitocin, Syntocinon

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108302

Locations
India
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
Belgaum, Karnataka, India
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
PATH
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Cynthia Stanton, PhD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Shivaprasad Goudar, MD JN Medical College, Belgaum, India
  More Information

No publications provided

Responsible Party: Cynthia Stanton, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01108302     History of Changes
Other Study ID Numbers: GAT.1429-07882-2
Study First Received: April 2, 2010
Last Updated: January 6, 2012
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
uterotonic
oxytocin
randomized trial
India
community
hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014