Postpartum hemorrhage, prevention, blood loss, transfusion MedDRA version: 20.0 Level: PT Classification code 10036417 Term: Postpartum haemorrhage System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions MedDRA version: 20.0 Level: SOC Classification code 10036585 Term: Pregnancy, puerperium and perinatal conditions System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: adult women admitted for a cesarean delivery before or during labor, at a term = 34 weeks, hemoglobin level at the last blood sample >9g/dl, blood Formula numbering within 3 days before caesarean delivery, informed signed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4524 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: previous thrombotic event or preexisting pro-thrombotic disease, epilepsy, any known cardiovascular, renal, liver disorder, severe hemorrhagic disease, autoimmune disease, sickle cell disease, placenta praevia, placenta accreta/increta/percreta, abruption placentae, eclampsia, HELLP syndrome, in utero fetal death, administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery, general anesthesia, instrumental extraction failure, multiple pregnancy with genital delivery of the first twin and caesarean delivery for the second or at third trimester
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the efficacy of a low dose of tranéxamic acid (1g) delivered within two minutes of the birth of a child by caesarean section versus placebo for the prevention of postpartum hemorrhage (PPH), defined by a Calculated blood loss of more than 1000mL (calculated blood loss = estimated blood volume x (preoperative Ht - preoperative Ht) / Ht preoperative (with estimated blood volume (in mL) = weight (in kg) x 85) A transfusion into globular concentrates before the second postpartum day (D2);Secondary Objective: - To compare the effect of a low dose of tranéxamic acid (1g) versus placebo, delivered after caesarean delivery on other markers of postpartum blood loss. - To evaluate the impact of a low dose of tranéxamic acid (1g) versus placebo, delivered after caesarean delivery, on the occurrence of potential side effects of traxenamic acid;Primary end point(s): Incidence of PPH defined by a calculated blood loss > 1,000mL [Calculated estimated blood loss = estimated blood volume × (preoperative Ht – postoperative Ht)/preoperative Ht (where estimated blood volume (mL) = booking weight (Kg) × 85)] or red blood cell transfusion before day 2 postpartum. Preoperative Ht will be the most recent Ht within one week before delivery. Postoperative Ht will be measured at D2.;Timepoint(s) of evaluation of this end point: On the day of the cesarean delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) other markers of postpartum blood loss: mean calculated blood loss > 500mL, >1000mL, and >1,500 mL; total mean calculated blood loss; mean gravimetrically estimated blood loss at the end of the cesarean delivery just before the transfer of the women to the PACU, and just before discharge from PACU, by measuring the suction volume and swab weight; proportion of women requiring supplementary uterotonic treatment including sulprostone; incidence of postpartum transfusion; incidence of arterial embolisation and emergency surgery for PPH; mean peripartum change in haemoglobin (difference between the most recent Hb within one week before delivery and at D2); mean peripartum change in hematocrit (difference between the most recent Ht within one week before delivery and at D2); 2) occurrence of potential adverse effects of TXA after cesarean delivery: Hemodynamic parameters (heart rate, blood pressure) 15, 30, 45, 60 and 120 minutes after delivery; nausea, vomiting, phosphenes, dizziness during the stay in the labor ward; mean urea and creatinemia as well as prothrombin time (PT), active prothrombin time (aPTT), aspartate and alanine transaminase, total bilirubin and fibrinogen at D2 ; deep venous thrombosis, pulmonary embolism, myocardial infarction, seizure, renal failure defined by the need for dialysis, occurring within twelve weeks after the delivery; 3) women’s satisfaction assessed by a self-administered questionnaire at day 2 and eight weeks postpartum;Timepoint(s) of evaluation of this end point: On the day of the cesaerian delivery, immediate postpartum, and at day 2, week 8 and week 12 postpartum | — |
Countries
France
Contacts
Public ContactSophie Regueme
CHU de Bordeaux
Outcome results
None listed