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

NCT01108302 | Withdrawn DMC

• 1 other identifier: GAT.1429-07882-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Keywords

uterotonic; oxytocin; randomized trial; India; community; hemorrhage

Outcome Measures

Primary Outcomes (1)

• postpartum hemorrhage

  blood loss \>=500 ml after delivery of the baby, as measured through a plastic calibrated drape.

  after delivery of baby

Secondary Outcomes (4)

• Oxytocin use before delivery

  labor and delivery

• stillbirth

  pregnancy

• neonatal death

  first month of life

• need for neonatal resuscitation

  0-6 hours after birth

Study Arms (2)

PPH Treatment only

NO INTERVENTION

Auxilliary nurse midwives will be able to treat for PPH only, not provide Oxytocin in Uniject

Oxytocin in Uniject

EXPERIMENTAL

Auxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery

Other: Oxytocin in Uniject

Interventions

Oxytocin in Uniject OTHER

10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Also known as: Pitocin, Syntocinon

Oxytocin in Uniject

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Jawaharlal Nehru Medical College Women's and Children's Health Research Unit: collaborator
• PATH: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Jawaharlal Nehru Medical College Women's and Children's Health Research Unit

Belagavi, Karnataka, India

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Cynthia Stanton, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Shivaprasad Goudar, MD

  JN Medical College, Belgaum, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 21, 2010
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 9, 2012

Record last verified: 2011-12

Locations

IN (1)