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Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery

NCT02302456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4079

Last updated 2017-09-06

No results posted yet for this study

Summary

The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.

Conditions

  • Immediate Postpartum Hemorrhage

Interventions

DRUG

Tranexamic Acid

Intravenous administration of a 10 mL solution containing 1g of tranexamic acid within 2 minutes of birth and routine prophylactic IV injection of oxytocin

DRUG

Placebo

Intravenous administration of 10 mL of 0.9% sodium chloride solution within 2 minutes of birth and routine prophylactic IV injection of oxytocin

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Loic SENTILHES, MD PhD · Department of Obstetrics, Angers University Hospital Center

  • Catherine DENEUX-THARAUX, MD PhD · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-01-31
Completion
2017-04-30

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT02302456 on ClinicalTrials.gov