Actively Recruiting

Phase 3
Age: 18Years - 65Years
FEMALE
NCT04304625

TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA

Led by University Hospital, Bordeaux · Updated on 2025-02-10

1380

Participants Needed

1

Research Sites

368 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Several randomized, controlled trials, mostly involving women undergoing cesarean delivery, have shown that the prophylactic intravenous administration of 1 g of tranexamic acid after childbirth reduced blood loss. Most were small, single-centre trials with considerable methodologic limitations. It is important to emphasize that none of these RCTs has included women at increased risk of PPH such as placenta previa, a context in which the prevalence of moderate and severe blood loss is significantly higher and where the magnitude of the effect of TXA may highly differ compared to low risk women

CONDITIONS

Official Title

TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Placenta previa with placental edge less than 20mm from the internal cervical opening confirmed by recent ultrasound
  • Cesarean delivery planned before or during labor
  • Gestational age at delivery 32 weeks or more
  • Affiliated with or beneficiary of a health security system
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • History of venous or arterial blood clots such as deep vein thrombosis, pulmonary embolism, angina, heart attack, or stroke
  • History of epilepsy or seizures
  • Chronic or acute heart or kidney disease, including heart transplant or kidney failure with low filtration rate
  • Chronic or acute liver disease with bleeding or clotting risks
  • Active autoimmune diseases with clotting risk like lupus or Crohn's disease
  • Sickle cell disease (homozygous)
  • Severe blood clotting or bleeding disorders excluding pregnancy-related changes
  • High suspicion of placenta accreta spectrum disorder
  • Placenta previa diagnosed during delivery
  • Abruptio placentae
  • Significant bleeding over 500ml within 12 hours before cesarean
  • Conditions like eclampsia or HELLP syndrome
  • Fetal death before birth
  • Use of blood thinners or antiplatelet drugs within 7 days before delivery
  • Contraindications to tranexamic acid or sodium chloride
  • Women under legal protection
  • Poor understanding of the French language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

CHU Bordeaux

Bordeaux, France

Actively Recruiting

Loading map...

Research Team

L

Loic Sentilhes, MD, PhD

CONTACT

A

Aurélie Darmaillacq

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here