Actively Recruiting

Phase 3
Age: 18Years - 65Years
FEMALE
ID04304625

Tranexamic Acid for Preventing Blood Loss Following Cesarean Delivery in Women With Placenta Previa: A Multicenter Randomised, Double Blind Placebo Controlled Trial

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

1380

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of tranexamic acid (TXA) to prevent blood loss after cesarean delivery in women with placenta previa, a condition that increases the risk of postpartum hemorrhage (PPH). Previous smaller trials have shown that TXA can reduce blood loss in general cesarean deliveries, but none have focused on women at higher risk like those with placenta previa. This large multicenter trial aims to provide clearer evidence on TXA's impact in this specific group. Participants will receive standard uterotonic treatment (either oxytocin or carbetocin) as part of usual care after childbirth. Within three minutes after birth and once the umbilical cord is clamped, they will be given an intravenous dose of either 1 gram of tranexamic acid or a placebo. The administration is slow, lasting 30 to 60 seconds. The study is randomized, double-blind, and placebo-controlled to compare TXA's effectiveness against a placebo. During the study, researchers will monitor various outcomes, including the need for red blood cell transfusions, the amount of blood loss measured by weight, incidence of severe bleeding, and other health events up to 12 weeks after delivery. They will also assess maternal satisfaction and psychological status eight and twelve weeks postpartum. Participants will be followed from delivery until hospital discharge and through postpartum assessments to evaluate safety and treatment effects.

CONDITIONS

Brief 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 within 20mm of the internal cervical opening confirmed by recent ultrasound
  • Scheduled for cesarean delivery before or during labor
  • Gestational age at delivery of 32 weeks or more
  • Covered by a health security system
  • Provided signed informed consent
Not Eligible

You will not qualify if you...

  • History of venous or arterial blood clots (deep vein thrombosis, pulmonary embolism, angina, heart attack, stroke)
  • History of epilepsy or seizures
  • Chronic or acute heart or kidney disease, including heart transplant or pulmonary hypertension
  • Active autoimmune diseases with clotting risk
  • Homozygous sickle cell disease
  • Severe bleeding or clotting disorders aside from pregnancy
  • High suspicion of placenta accreta spectrum disorder
  • Placenta previa diagnosed during delivery
  • Abruptio placentae
  • Significant bleeding over 500ml within 12 hours before cesarean
  • Eclampsia or HELLP syndrome
  • Fetal death in the womb
  • Use of blood thinners within 7 days before delivery
  • Contraindications to tranexamic acid or sodium chloride
  • Under legal protection
  • Poor understanding of French language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single dose administered immediately after delivery

Participants receive a single intravenous dose of the study drug (tranexamic acid or placebo) within 3 minutes after cesarean delivery once the umbilical cord has been clamped, following routine prophylactic uterotonic administration.

1 baseline visit (cesarean delivery)

Follow-up

Duration - Up to 12 weeks after delivery

Participants are monitored during their postpartum hospital stay and up to 12 weeks after delivery for safety and outcomes including blood loss, transfusions, adverse reactions, and psychological status.

Multiple visits including assessments at 15, 30, 45, 60, and 120 minutes after birth, day 2, and follow-up visits at Week 8 and Week 12

Trial Site Locations

Total: 1 location

1

CHU Bordeaux

Bordeaux, France

Actively Recruiting

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Research Team

L

Loic Sentilhes, MD, PhD

A

Aurélie Darmaillacq

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Study protocol. TRAAPREVIA-TRAnexamic acid for preventing blood loss following a cesarean delivery in women with a placenta pREVIA or low-lying placenta: a multicenter randomized, double blind, placebo controlled trial.

Loïc Sentilhes, Hugo Madar, Amélie Ifrah...

https://pubmed.ncbi.nlm.nih.gov/40448004