Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01710566
Recruitment Status : Withdrawn
First Posted : October 19, 2012
Last Update Posted : February 15, 2016
Aga Khan Health Services
Department of Health and Family Welfare, Government of Gujarat
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
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 or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Misoprostol Drug: Oxytocin Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in Uniject®
Study Start Date : July 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Mean change in Pre- and post-delivery Haemoglobin [ Time Frame: 18 months ]
    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 :
  1. Safety [ Time Frame: 18 months ]
    Occurrence and management of side effects, timing of drug administration and serious adverse outcomes

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

  3. Programmatic feasibility [ Time Frame: 18 months ]
    Acceptability among women and providers,drug accountability, disposal and management, any problems to report, refusals or complaints by women or their families

  4. Cost-effectiveness [ Time Frame: 18 months ]
    Costs of supplies, wastage, refresher trainings, storage and transportation, referrals and management of side effects will be assessed.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Layout table for additonal information
Responsible Party: Gynuity Health Projects Identifier: NCT01710566     History of Changes
Other Study ID Numbers: 1.3.4
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016

Keywords provided by Gynuity Health Projects:
Postpartum hemorrhage

Additional relevant MeSH terms:
Layout table for MeSH terms
Postpartum Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents