Misoprostol and Oxytocin in Uniject® for Postpartum Hemorrhage Prevention in Communities

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2012 by Gynuity Health Projects
Sponsor:
Collaborators:
Aga Khan Health Services
Department of Health and Family Welfare, Government of Gujarat
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01710566
First received: May 8, 2012
Last updated: October 17, 2012
Last verified: May 2012
  Purpose

This community-based cluster Randomised Control Trial will assess the feasibility, cost, risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as prophylaxis for postpartum hemorrhage (PPH) in community settings. The study will be conducted in Jamnagar district in Gujarat state in India. The hypothesis is that a program to deliver oral misoprostol and one to deliver oxytocin via Uniject® will both be effective in preventing PPH when introduced in community-based settings.


Condition Intervention Phase
Postpartum Hemorrhage
Drug: Misoprostol
Drug: Oxytocin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in Uniject®

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Mean change in Pre- and post-delivery Haemoglobin [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    To establish the comparable effectiveness of two programmatic strategies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.


Secondary Outcome Measures:
  • Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Occurrence and management of side effects, timing of drug administration and serious adverse outcomes

  • Clinical effectiveness [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Change in hemoglobin ≥ 2 g/dL, prolonged third stage of labor, any additional interventions carried out.

  • Programmatic feasibility [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Acceptability among women and providers,drug accountability, disposal and management, any problems to report, refusals or complaints by women or their families

  • Cost-effectiveness [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Costs of supplies, wastage, refresher trainings, storage and transportation, referrals and management of side effects will be assessed.


Estimated Enrollment: 1500
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
600 mcg oral misoprostol
Drug: Misoprostol
600 mcg oral misoprostol to be administered after delivery of baby and before placenta is expelled
Other Name: Misoprost
Experimental: Group 2
10 IU oxytocin in Uniject
Drug: Oxytocin
10 IU oxytocin in Uniject will be administered after delivery of baby and before placenta is expelled
Other Name: Oxytocin in Uniject

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women planning vaginal delivery with a trained study provider at a PHC who are eligible to participate in research according to national guidelines and able to provide informed consent.

Exclusion Criteria:

  • Women not delivering in study catchment area with a trained study provider will not be eligible to participate in the trial.
  • Women with known contraindications to prostaglandins, including misoprostol will also be excluded.
  • Women delivering in a facility that currently routinely administers prophylactic oxytocin to women in the third stage labor will also be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01710566     History of Changes
Other Study ID Numbers: 1.3.4
Study First Received: May 8, 2012
Last Updated: October 17, 2012
Health Authority: India: Indian Council of Medical Research
India: Drugs Controller General of India

Keywords provided by Gynuity Health Projects:
Postpartum hemorrhage
prevention
oxytocin
misoprostol
Uniject
community

Additional relevant MeSH terms:
Postpartum Hemorrhage
Puerperal Disorders
Hemorrhage
Obstetric Labor Complications
Pathologic Processes
Pregnancy Complications
Uterine Hemorrhage
Misoprostol
Oxytocin
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014