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

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ClinicalTrials.gov Identifier: NCT01710566
Recruitment Status : Withdrawn
First Posted : October 19, 2012
Last Update Posted : February 15, 2016
Sponsor:
Collaborators:
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

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

U.S. FDA Resources

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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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.

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov 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
prevention
oxytocin
misoprostol
Uniject
community

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