TRANEXAMIC ACID for Placenta previa | Postpartum hemorrhage

Inclusion criteria

• {"criterion_text":"-Age≥ 18 years"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Cesarean delivery before or during labor"}
• {"criterion_text":"-Gestational age at delivery ≥ 32 weeks + 0"}
• {"criterion_text":"-Affiliated or beneficiary to a health security system"}
• {"criterion_text":"-Signed informed consent"}

Exclusion criteria

• {"criterion_text":"-History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombotic event"}
• {"criterion_text":"-Placenta praevia diagnosed during delivery"}
• {"criterion_text":"-Abruptio placentae"}
• {"criterion_text":"-Significant bleeding (estimated blood loss > 500ml) within 12 hours before cesarean delivery"}
• {"criterion_text":"-Eclampsia / HELLP syndrome"}
• {"criterion_text":"-In utero fetal death"}
• {"criterion_text":"-Administration of low-molecular-weight heparin or antiplatelet agents during the 7 days before delivery"}
• {"criterion_text":"-Tranexamic acid contraindication"}
• {"criterion_text":"-Sodium chloride contraindication"}
• {"criterion_text":"-Women under legal protection"}
• {"criterion_text":"-Poor understanding of the French language"}
• {"criterion_text":"-History of epilepsy or seizure"}
• {"criterion_text":"-Chronic or acute cardiovascular disease (including foramen oval, mitral stenosis, aortic stenosis, heart transplant, pulmonary hypertension)"}
• {"criterion_text":"-Chronic or acute renal disease (including chronic or acute kidney failure with glomerular filtration rate <90 mL/min, renal transplantation)"}
• {"criterion_text":"-Chronic active, or acute, liver disorder with hemorrhagic or thrombotic risk (including cirrhosis, portal hypertension, Budd-Chiari syndrome)"}
• {"criterion_text":"-Active autoimmune disease with thromboembolic risk (including lupus, antiphospholipid syndrome, Crohn’s disease)"}
• {"criterion_text":"-Sickle cell disease (homozygous)"}
• {"criterion_text":"-Severe hemostasis disorder \tProthrombotic (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), \tProhemorragic such as von Willebrand disease requiring desmopressin treatment during delivery, Thrombocytopenia (< 30 000 /mm3), Glanzmann disease, hypofibrinogenemia (< 1 g/L) aside from pregnancy)"}
• {"criterion_text":"-High prenatal suspicion of placenta accreta spectrum disorder according to the obstetrician in charge"}

Primary endpoints

• {"endpoint_text":"-Incidence of red blood cell transfusion between delivery of child and discharge from postpartum hospital stay.","definition_or_measurement_approach":"Incidence of red blood cell transfusion between delivery of child and discharge from postpartum hospital stay."}

Secondary endpoints

• {"endpoint_text":"-Mean gravimetrically estimated blood loss, by measuring the suction volume and swab weight according to Gai et al (estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/1.05 + volume included in the suction container)","definition_or_measurement_approach":"Estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/1.05 + volume in suction container (gravimetric method)."}
• {"endpoint_text":"-Calculated blood loss > 1000 mL. Calculated blood loss = estimated blood volume × (preoperative Ht -postoperative Ht)/preoperative Ht (where estimated blood volume = weight (kg) × 85)\"","definition_or_measurement_approach":"Calculated blood loss = estimated blood volume × (preoperative Ht - postoperative Ht)/preoperative Ht, with estimated blood volume (mL) = weight (kg) × 85. Preoperative Ht = most recent Ht within 7 days before delivery; postoperative Ht measured at day 2 postpartum."}
• {"endpoint_text":"-Calculated blood loss > 1500 ml","definition_or_measurement_approach":"Calculated blood loss as defined above; threshold >1500 mL."}
• {"endpoint_text":"-Mean calculated blood loss","definition_or_measurement_approach":"Mean of calculated blood loss using the formula described for calculated blood loss (estimated blood volume × (preoperative Ht - postoperative Ht)/preoperative Ht)."}
• {"endpoint_text":"-Mean shock index, defined by the ratio of heart rate to systolic blood pressure, measured at 15, 30, 45, 60 and 120 minutes after birth, or if PPH occurs","definition_or_measurement_approach":"Shock Index = heart rate / systolic blood pressure; measured at 15, 30, 45, 60 and 120 minutes after birth, or at PPH occurrence."}
• {"endpoint_text":"-Supplementary uterotonic treatment","definition_or_measurement_approach":"Proportion of women receiving additional uterotonic treatment after prophylactic uterotonic."}
• {"endpoint_text":"-Iron sucrose perfusion until discharge","definition_or_measurement_approach":"Proportion of women receiving iron sucrose infusion during hospital stay until discharge."}
• {"endpoint_text":"-Number of red blood cell units transfused between delivery of child and discharge from postpartum hospital stay.","definition_or_measurement_approach":"Mean or total number of red blood cell units transfused between delivery and hospital discharge."}
• {"endpoint_text":"-Proportion of women transfused between delivery of child and 24 hours postpartum","definition_or_measurement_approach":"Proportion of women receiving at least one RBC transfusion between delivery and 24 hours postpartum."}
• {"endpoint_text":"-Arterial embolisation or emergency surgery for PPH","definition_or_measurement_approach":"Proportion of women requiring arterial embolisation or emergency haemostatic surgery for postpartum haemorrhage."}
• {"endpoint_text":"-Maternal postpartum transfer to a higher level of care","definition_or_measurement_approach":"Proportion of women transferred to intensive care, high-dependency unit, or to a maternity with higher level of care postpartum."}
• {"endpoint_text":"-Proportion of breastfeeding at hospital discharge","definition_or_measurement_approach":"Proportion of women breastfeeding at hospital discharge."}
• {"endpoint_text":"-Maternal death for any cause","definition_or_measurement_approach":"All-cause maternal mortality assessed during the follow-up period."}
• {"endpoint_text":"-Mean change in peripartum hemoglobin (difference between the most recent Hb within 7 days before delivery and at day 2 postpartum)","definition_or_measurement_approach":"Mean difference between preoperative Hb (most recent within 7 days before delivery) and Hb measured at day 2 postpartum."}
• {"endpoint_text":"-Mean change in peripartum hematocrit (difference between the most recent Ht within 7 days before delivery and at day 2 postpartum).","definition_or_measurement_approach":"Mean difference between preoperative Ht (most recent within 7 days before delivery) and Ht at day 2 postpartum."}
• {"endpoint_text":"-Occurrence of potential mild adverse reactions of TXA for women : nausea, vomiting, phosphenes, dizziness (these events will be identified in the theatre room as well as during the postpartum stay in hospital);","definition_or_measurement_approach":"Incidence of specified mild adverse reactions (nausea, vomiting, phosphenes, dizziness) identified from delivery room through hospital stay."}
• {"endpoint_text":"-Occurrence of thromboembolic events and other severe unexpected adverse reactions (i.e. incidence of deep vein thrombosis confirmed by radiological exams, pulmonary embolism confirmed by radiological exams, myocardial infarction, seizure, renal failure necessitating dialysis ) - (these events will be assessed up to 12 weeks after the delivery, telephone interview at 12 weeks postpartum)","definition_or_measurement_approach":"Incidence of major thromboembolic events and other severe unexpected adverse reactions confirmed by appropriate diagnostics; assessed up to 12 weeks postpartum including telephone interview at 12 weeks."}
• {"endpoint_text":"-Occurrence of neonatal outcomes: transfer to neonatal ICU.","definition_or_measurement_approach":"Proportion of neonates transferred to neonatal intensive care unit."}
• {"endpoint_text":"-Self-administered questionnaire at day 2 postpartum assessing women’s satisfaction regarding their delivery and their psychological status","definition_or_measurement_approach":"Patient-reported satisfaction and psychological status using a self-administered questionnaire at day 2 postpartum."}
• {"endpoint_text":"-Self-administered questionnaire sent by mail at 8 weeks of postpartum, assessing their psychological status","definition_or_measurement_approach":"Patient-reported psychological status assessed via mailed self-administered questionnaire at 8 weeks postpartum."}

France

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

17-09-2024

Processing Time Days

5

Number Of Sites

32

Number Of Participants

1380

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France