postpartum hemorrhage
Conditions
Interventions
Trade Name: Exacyl® 0.5g-5mL
Product Name: Acide Tranexamique
Product Code: B02AA02
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo
Sponsors
CHU d'Angers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult women in labour for a planned vaginal delivery, at a term = 35 weeks, with a singleton fetus. 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 4000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of thrombosis and epilepsy, any known cardiovascular, renal, liver disorders, age<18, severe hemorrhagic disease, multiple pregnancy, placenta praevia, abnormal placentation, abruption placentae, eclampsia, in utero foetal death, poor understanding of the French language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 15 minutes;Main Objective: To compare the effect of a low dose of TXA (1g) after vaginal delivery, within 2 minutes after delivery of the child, versus placebo on the incidence of PPH, defined by blood loss = 500 ml, measured with a graduated collector bag.;Secondary Objective: To compare the effect of a low dose of TXA (1g) after vaginal delivery versus placebo on outcome measures describing the postpartum blood loss To describe the occurrence of potential adverse effects of TXA (1g) after vaginal delivery ;Primary end point(s): incidence de l'HPP définie par des pertes sanguines = 500 ml, mesurées à l'aide d'un sac de recueil gradué en salle de travail | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) outcome measures describing the postpartum blood loss: mean measured blood loss at 15 minutes after birth (the collector bag will have to be left in place at least 15 minutes to have one measure of blood loss at the same time point in all women); mean measured total postpartum blood loss (at bag removal); incidence of severe PPH, defined by blood loss = 1000 ml; 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 Hb during last trimester of pregnancy and at D2); mean peripartum change in hematocrit (difference between Ht during last trimester of pregnancy and at D2) / 2) occurrence of potential adverse effects of TXA (1g) after vaginal delivery: Hemodynamic parameters (heart rate, blood pressure) 15, 30, 45, 60 and 120 minutes after delivery; nausea, vomiting, phosphenes, dizziness occurring during the stay of the women in the labor ward; deep vein thrombosis, pulmonary embolism, myocardial infarction, seizure, renal failure defined by the need for dialysis occurring within twelve weeks after the delivery; mean urea and creatinemia as well as prothrombin time (PT), active prothrombin time (aPTT), aspartate and alanine transaminase and total bilirubin at D2 / 3) women’s satisfaction assessed by a self administered questionnaire on day 2 postpartum.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
France
Contacts
Public ContactDirection de la Recherche
CHU d'Angers
Outcome results
None listed