The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.
Randomised, double-blind,multicenter, placebo-controlled study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
448
Injection as soon as possible and within 30 min following the start of prostaglandin infusion
As soon as possible and within 30 min following the start of prostaglandin infusion
CH Félix Guyon
Failure Rate of PPH Management
The primary efficacy variable is a binary (Failure versus Success) composite endpoint. Failure is defined when a patient: * loses at least 4 g/dL of Hb compared to the reference Hb level , AND/OR * requires the transfusion of at least 2 units of packed RBCs.
Time frame: Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration
Patients With at Least Administration of 2 Units of RBCs
Considering failure as the fact of requiring at least 2 units of RBCs.
Time frame: from H0 to Day 2
Patients With Loss of at Least 4 g/dL of Hb
Considering failure as the fact of having lost at least 4 g/dL of Hb.
Time frame: From reference value to Day 2
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Saint-Denis, Réunion, France
Groupe Hospitalier Sud Réunion
Saint-Pierre, Réunion, France
CHU d'Angers
Angers, France
Hôpital Privé d'Antony
Antony, France
Centre Hospitalier Fleyriat
Bourg-en-Bresse, France
Hôpital Femme Mère Enfant
Bron, France
Hôpital Antoine Béclère
Clamart, France
CHU Estaing
Clermont-Ferrand, France
Hôpital Louis Mourier
Colombes, France
Les Hôpitaux de Chartres (Hôpital Pasteur)
Le Coudray, France
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