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

NCT01710566 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-02-15

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Misoprostol

600 mcg oral misoprostol to be administered after delivery of baby and before placenta is expelled

DRUG

Oxytocin

10 IU oxytocin in Uniject will be administered after delivery of baby and before placenta is expelled

Sponsors & Collaborators

  • Aga Khan Health Services

    collaborator OTHER

  • Department of Health and Family Welfare, Government of Gujarat

    collaborator UNKNOWN

  • Gynuity Health Projects

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01710566 on ClinicalTrials.gov