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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Mar 9, 2020

Keywords

ClinConnect Summary

This clinical trial, titled "TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA," is studying whether a medication called tranexamic acid can help reduce blood loss in women who have placenta previa and are undergoing a cesarean delivery. Placenta previa is a condition where the placenta is positioned low in the uterus, which can lead to significant bleeding during and after delivery. The trial aims to see if giving tranexamic acid just after childbirth can help women at higher risk of bleeding, as previous studies have mostly looked at women with lower risk.

To participate in this trial, women must be at least 18 years old, diagnosed with placenta previa, and scheduled for a cesarean delivery after 32 weeks of pregnancy. They should also be able to provide informed consent and be part of a health security system. However, women with certain health conditions, such as a history of blood clots, severe heart or kidney issues, or specific bleeding disorders, cannot participate. If eligible, participants can expect to receive the study medication after their delivery and will be closely monitored for any changes in blood loss. It's important to note that this trial is currently recruiting participants and aims to provide valuable insights for improving care in high-risk pregnancies.

Gender

FEMALE

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