Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India
NCT ID: NCT01108302
Last Updated: 2012-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-09-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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PPH Treatment only
Auxilliary nurse midwives will be able to treat for PPH only, not provide Oxytocin in Uniject
No interventions assigned to this group
Oxytocin in Uniject
Auxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery
Oxytocin in Uniject
10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
Interventions
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Oxytocin in Uniject
10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
Yes
Sponsors
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Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
UNKNOWN
PATH
OTHER
Bill and Melinda Gates Foundation
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Johns Hopkins Bloomberg School of Public Health
Principal Investigators
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Cynthia Stanton, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Shivaprasad Goudar, MD
Role: PRINCIPAL_INVESTIGATOR
JN Medical College, Belgaum, India
Locations
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Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
Belagavi, Karnataka, India
Countries
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Other Identifiers
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GAT.1429-07882-2
Identifier Type: -
Identifier Source: org_study_id
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