Using tranexamic acid to reduce blood loss after cesarean delivery in women with placenta previa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of tranexamic acid (TXA) in preventing postpartum hemorrhage (PPH) in women diagnosed with placenta previa undergoing cesarean delivery. The study aims to administer 1 g of TXA intravenously after childbirth to assess its impact on blood loss, particularly in a high-risk population where traditional studies have not focused. By addressing the limitations of previous trials, this research seeks to provide robust evidence on the use of TXA in this specific context, potentially influencing clinical guidelines for managing cesarean deliveries in women with placenta previa.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age≥ 18 years
* Placenta previa defined by a placental edge below 20mm from internal cervical os diagnosed at the most recent transvaginal ultrasound examination before delivery, as per French guidelines
* Cesarean delivery before or during labor
* Gestational age at delivery ≥ 32 weeks + 0
* Affiliated or beneficiary to a health security system
* Signed informed consent

Exclusion Criteria:

* History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombotic event
* History of epilepsy or seizure
* Chronic or acute cardiovascular disease (including foramen oval, mitral stenosis, aortic stenosis, heart transplant, pulmonary hypertension); chronic or acute renal disease (including chronic or acute kidney failure with glomerular filtration rate \<90 mL/min, renal transplantation), chronic active or acute liver disorder with hemorrhagic or thrombotic risk (including cirrhosis, portal hypertension, Budd-Chiari syndrome)
* Active autoimmune disease with thromboembolic risk (including lupus, antiphospholipid syndrome, Crohn's disease)
* Sickle cell disease (homozygous)
* Severe hemostasis disorder prothrombotic (Factor V Leiden mutation - homo or heterozygous; Activated protein C (APC) resistance, Protein C deficiency, Protein S deficiency - aside from pregnancy, Homocysteinemia, , Factor 2 mutation - homo or heterozygous, Deficiency in antithrombin 3), prohemorragic (von Willebrand disease requiring desmopressin treatment during delivery, thrombocytopenia (\<30000/mm3), Glanzmann disease, hypofibrinogenemia (\<1g/L) -aside from pregnancy)
* High prenatal suspicion of placenta accreta spectrum disorder according to the obstetrician in charge
* Placenta praevia diagnosed during delivery
* Abruptio placentae
* Significant bleeding (estimated blood loss\>500ml) within 12 hours before cesarean delivery
* Eclampsia / HELLP syndrome
* In utero fetal death
* Administration of low-molecular-weight heparin or antiplatelet agents during the 7 days before delivery
* Tranexamic acid contraindication
* Sodium chloride contraindication
* Women under legal protection
* Poor understanding of the French language

Where it's running

• CHU Bordeaux
  Bordeaux, France Recruiting

Study contacts

• Study coordinator: Loic Sentilhes, MD, PhD
• Email: loic.sentilhes@chu-bordeaux.fr
• Phone: +335 56 79 55 79

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.