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

Postpartum Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01108302
• Other study ID #: GAT.1429-07882-2
• Status: Withdrawn
• Phase: N/A
• First received: April 2, 2010
• Last updated: January 6, 2012
• Start date: September 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2011
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Other:
• Oxytocin in Uniject
10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Locations

Country	Name	City	State
India	Jawaharlal Nehru Medical College Women's and Children's Health Research Unit	Belgaum	Karnataka

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Bill and Melinda Gates Foundation, Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, PATH

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postpartum hemorrhage	blood loss >=500 ml after delivery of the baby, as measured through a plastic calibrated drape.	after delivery of baby	No
Secondary	Oxytocin use before delivery	the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby	labor and delivery	Yes
Secondary	stillbirth	stillbirth is defined as death of a fetus after 28 weeks of gestation and before birth of the baby	pregnancy	Yes
Secondary	neonatal death	neonatal death is defined as death of a live born infant prior to completion of 28 days	first month of life	Yes
Secondary	need for neonatal resuscitation		0-6 hours after birth	Yes