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RECRUITING

NCT04304625

PHASE3

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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

Official title: TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA: a Multicenter Randomised, Double Blind Placebo Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

1380

Start Date

2020-08-07

Completion Date

2027-09

Last Updated

2025-02-10

Healthy Volunteers

Conditions

Postpartum Hemorrhage

Interventions

DRUG

Tranexamic Acid / Sodium chloride

After the routine prophylactic IV or IM injection of the uterotonic used in the hospital protocol's -either oxytocin or carbetocin - (as recommended by the 2014 guidelines for prevention and management of postpartum hemorrhage from the CNGOF), the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the patient within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped

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

Locations (1)

CHU Bordeaux

Bordeaux, France