Back to resultsEffectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India
Primary Purpose
Postpartum Hemorrhage
Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Oxytocin in Uniject
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring uterotonic, oxytocin, randomized trial, India, community, hemorrhage
Eligibility 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
Sites / Locations
- Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
PPH Treatment only
Oxytocin in Uniject
Arm Description
Auxilliary nurse midwives will be able to treat for PPH only, not provide Oxytocin in Uniject
Auxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery
Outcomes
Primary Outcome Measures
postpartum hemorrhage
blood loss >=500 ml after delivery of the baby, as measured through a plastic calibrated drape.
Secondary Outcome Measures
Oxytocin use before delivery
the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby
stillbirth
stillbirth is defined as death of a fetus after 28 weeks of gestation and before birth of the baby
neonatal death
neonatal death is defined as death of a live born infant prior to completion of 28 days
need for neonatal resuscitation
Full Information
NCT ID
NCT01108302
First Posted
April 2, 2010
Last Updated
January 6, 2012
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, PATH, Bill and Melinda Gates Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01108302
Brief Title
Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Withdrawn
Why Stopped
PATH withdrew IRB approval
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, PATH, Bill and Melinda Gates Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
uterotonic, oxytocin, randomized trial, India, community, hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPH Treatment only
Arm Type
No Intervention
Arm Description
Auxilliary nurse midwives will be able to treat for PPH only, not provide Oxytocin in Uniject
Arm Title
Oxytocin in Uniject
Arm Type
Experimental
Arm Description
Auxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery
Intervention Type
Other
Intervention Name(s)
Oxytocin in Uniject
Other Intervention Name(s)
Pitocin, Syntocinon
Intervention Description
10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
Primary Outcome Measure Information:
Title
postpartum hemorrhage
Description
blood loss >=500 ml after delivery of the baby, as measured through a plastic calibrated drape.
Time Frame
after delivery of baby
Secondary Outcome Measure Information:
Title
Oxytocin use before delivery
Description
the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby
Time Frame
labor and delivery
Title
stillbirth
Description
stillbirth is defined as death of a fetus after 28 weeks of gestation and before birth of the baby
Time Frame
pregnancy
Title
neonatal death
Description
neonatal death is defined as death of a live born infant prior to completion of 28 days
Time Frame
first month of life
Title
need for neonatal resuscitation
Time Frame
0-6 hours after birth
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Stanton, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shivaprasad Goudar, MD
Organizational Affiliation
JN Medical College, Belgaum, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
City
Belgaum
State/Province
Karnataka
Country
India
12. IPD Sharing Statement
Learn more about this trial
Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India
We'll reach out to this number within 24 hrs