Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
CHU Bordeaux
Bordeaux, France
Actively Recruiting
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
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