Status:
RECRUITING
TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
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 reduc...
Detailed Description
TXA is a promising candidate drug, inexpensive and easy to administer, that can be easily added to the delivery management of women worldwide. Strong evidence that TXA reduces blood transfusion in ele...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
1380 Patients enrolled
Trial Details
Trial ID
NCT04304625
Start Date
August 7 2020
End Date
September 1 2027
Last Update
February 10 2025
Active Locations (1)
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1
CHU Bordeaux
Bordeaux, France