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Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

NCT03364491 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11000

Last updated 2023-02-21

Study results available
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Summary

A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.

Conditions

  • Obstetrical Complications
  • Hemorrhage
  • Labor and Delivery

Interventions

DRUG

Tranexamic Acid

A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

DRUG

Placebo

50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Rebecca Clifton, Ph.D. · The George Washington University Biostatistics Center

  • Monica Longo, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Louis Pacheco, MD · UTMB

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2021-07-24
Completion
2021-10-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT03364491 on ClinicalTrials.gov