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TRAnexamic Acid for Preventing blood loss following a cesarean delivery in women with placenta pREVIA: a multicenter randomised, double blind placebo controlled trial. TRAAPrevia
EU CTIS ID: 2024-515276-12-00
What this study is testing
To compare the effect of a low dose of TXA (1g) administered within 3 minutes after delivery of the child in addition to prophylactic uterotonic in women with placenta previa and cesarean delivery, versus placebo, on the incidence of red blood cell (RBC) transfusion between delivery of child and discharge from postpartum hospital stay
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombotic event
- 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
See the full eligibility 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
- History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombotic event
- 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
- 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 such as von Willebrand disease requiring desmopressin treatment during delivery, Thrombocytopenia (< 30 000 /mm3), Glanzmann disease, hypofibrinogenemia (< 1 g/L) aside from pregnancy)
- High prenatal suspicion of placenta accreta spectrum disorder according to the obstetrician in charge
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.