impact de l'injection d'acide tranexamique en prévention de l'hémorragie du post partum après un accouchement par voie basse
Phase 1
- Conditions
- postpartum hemorrhageTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2014-001748-39-FR
- Lead Sponsor
- CHU d'Angers
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>To describe the occurrence of potential adverse effects of TXA (1g) after vaginal delivery<br>;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 Outcome Measures
Name Time Method