This is a prospective multicentre, randomised, double-blind, placebo-controlled trial. A total of 412 patients will be randomised if they meet the following criteria: female patients ≥ 18 years old, vaginal delivery, PPH requiring IV administration of prostaglandins (sulprostone) after 20 to 30 minutes of oxytocin failure. The participants are assigned to receive either fibrinogen 3 g or placebo infusions. The primary endpoint is a composite endpoint defined as the percentage of patients losing at least 4 g/dL of Hb, and/or requiring a transfusion of at least 2 units of packed red blood cells, within the 48 hours following fibrinogen administration.
The purpose of this study is to demonstrate the efficacy and safety of an early fibrinogen concentrate infusion in uncontrolled active PPH.