Misoprostol and Oxytocin in Uniject® for Postpartum Hemorrhage Prevention in Communities
Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in Uniject®
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
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Started Jul 2013
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 15, 2016
February 1, 2016
1.4 years
May 8, 2012
February 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in Pre- and post-delivery Haemoglobin
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.
18 months
Secondary Outcomes (4)
Safety
18 months
Clinical effectiveness
18 months
Programmatic feasibility
18 months
Cost-effectiveness
18 months
Study Arms (2)
Group 1
EXPERIMENTAL600 mcg oral misoprostol
Group 2
EXPERIMENTAL10 IU oxytocin in Uniject
Interventions
600 mcg oral misoprostol to be administered after delivery of baby and before placenta is expelled
10 IU oxytocin in Uniject will be administered after delivery of baby and before placenta is expelled
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynuity Health Projectslead
- Aga Khan Health Servicescollaborator
- Department of Health and Family Welfare, Government of Gujaratcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2012
First Posted
October 19, 2012
Study Start
July 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 15, 2016
Record last verified: 2016-02