NCT04304625 TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA
| NCT ID | NCT04304625 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Bordeaux |
| Condition | Postpartum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,380 participants |
| Start Date | 2020-08-07 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,380 participants in total. It began in 2020-08-07 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Eligibility 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, 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04304625 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Postpartum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04304625 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,380 participants.
Is NCT04304625 currently recruiting?
Yes, NCT04304625 is actively recruiting participants. Contact the research team at loic.sentilhes@chu-bordeaux.fr for enrollment information.
Where is the NCT04304625 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT04304625 clinical trial?
NCT04304625 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 1,380 participants.