TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: Female

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 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Carbetocin; Oxytocin; Tranexamic Acid

Criteria

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, ASAT>3N, 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