Fibrinogen in Haemorrhage of Delivery
Condition: Post-Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Intervention: Human Fibrinogen concentrate; Placebo
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 448.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PPH; fibrinogen; vaginal delivery

Summary:

      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.
    

Eligibility criteria:

        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