Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject⢠to Prevent Postpartum Hemorrhage in India
Information source: Johns Hopkins Bloomberg School of Public Health
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postpartum Hemorrhage
Intervention: Oxytocin in Uniject (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Johns Hopkins Bloomberg School of Public Health Official(s) and/or principal investigator(s):
Cynthia Stanton, PhD, Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health
Shivaprasad Goudar, MD, Principal Investigator, Affiliation: JN Medical College, Belgaum, India
Overall contact:
Cynthia Stanton, PhD, Phone: 301-741-5871, Email: cstanton@jhsph.edu
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: postpartum hemorrhage
Secondary outcome: Oxytocin use before deliverystillbirth neonatal death need for neonatal resuscitation
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Cynthia Stanton, PhD, Phone: 301-741-5871, Email: cstanton@jhsph.edu
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, Belgaum, Karnataka, India
Additional Information
Starting date: September 2010
Last updated: April 20, 2010
|
