Fibrinogen in Haemorrhage of Delivery

Randomised, double-blind,multicenter, placebo-controlled study

Inclusion criteria

• Signed and dated informed consent form
• Vaginal delivery
• PPH requiring IV administration of prostaglandins
• At least one available result of Hb level during the third trimester of pregnancy
• 18-year-old female patients and older
• Covered by healthcare insurance in accordance with local requirements

Exclusion criteria

• Caesarean section
• Haemostatic intervention (as ligation, embolization or hysterectomy) already decided at the time of inclusion
• Known placenta praevia or accreta
• Hb level < 10g/dl during the third trimester of pregnancy
• History of venous or arterial thromboembolic event
• Known inherited bleeding or thrombotic disorders
• Treatment with low-molecular-weight heparin (LMWH) within 24 hours prior to the inclusion
• Treatment with acetylsalicylic acid within 5 days prior to the inclusion
• Treatment with vitamin K antagonists within 7 days prior to the inclusion
• Administration of fibrinogen concentrate within 48 hours prior to the inclusion
• Administration of FFP, platelets units or prohaemostatic drugs, tranexamic acid and rFVIIa or prothrombin complex concentrates (PCC) within 48 hours prior to the inclusion
• Administration of RBCs within 3 months prior to the inclusion
• Participation in another interventional clinical study within 30 days prior to the inclusion
• Previous inclusion/enrolment in the present clinical study
• Known history of hypersensitivity or other severe reaction to any component of Clottafact® or placebo
• Minors, majors under guardianship, persons staying in health or social institutes and people deprived of their freedom
• Known drug or alcohol abuse
• Patients whose use of concomitant medication may interfere with the interpretation of data
• Any other current significant medical condition that might interfere with treatment evaluation according to the investigator's judgement
• Patients who are unlikely to survive through the treatment period and evaluation
• Patients transferred from another service