title: Fibrinogen concentrate as a treatment for postpartum haemorrhage-induced coagulopathy: A study protocol for a randomised multicentre controlled trial. The fibrinogen in haemorrhage of DELivery (FIDEL) trial.
abstract: BACKGROUND
  Postpartum haemorrhage (PPH) remains the leading cause for maternal mortality worldwide. Hypofibrinogenaemia has been identified as a major risk factor for progress towards severe PPH. The efficacy of fibrinogen concentrate supplementation in PPH has been shown in various clinical settings but the level of evidence is not sufficient to prove the benefit, evaluate the risks, and determine the value, timing and dose of fibrinogen supplementation in PPH. The FIDEL trial objective is to evaluate the impact of a therapeutic strategy based on the early administration of human fibrinogen concentrate compared to the current practice based on late administration in severe PPH patients requiring second line uterotonics.
  
  
  METHODS
  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 30minutes of oxytocin failure. The participants are assigned to receive either fibrinogen 3g or placebo infusions. The primary endpoint is a composite endpoint defined as the percentage of patients losing at least 4g/dL of Hb, and/or requiring a transfusion of at least 2 units of packed red blood cells, within the 48hours following fibrinogen administration.
  
  
  CONCLUSIONS
  The purpose of this study is to demonstrate the efficacy and safety of an early fibrinogen concentrate infusion in uncontrolled active PPH.
authors.affiliation: Academic hospital, maternité Jeanne-de-Flandre, Pôle anesthésie-réanimation, avenue Oscar-Lambret, 59037 Lille, France. Electronic address: anne-sophie.ducloy@chru-lille.fr.
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Ducloy-Bouthors
authors.affiliation: AP-HP, Maternité Cochin-Port-Royal, Pôle Anesthésie-Réanimation, 53, avenue de l'Observatoire, 75014 Paris, France. Electronic address: alexandre.mignon@me.com.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Mignon
authors.affiliation: Hospices Civils, Hôpital Croix-Rousse, Pôle Obstétrique et Gynécologie, 103, grande rue de la Croix-Rousse, 69004 Lyon, France. Electronic address: cyril.huissoud@chu-lyon.fr.
authors.forename: Cyril
authors.initials: C
authors.lastname: Huissoud
authors.affiliation: Université de Rouen, Inserm U657, 72, rue du Pré-des-Coulons, 78810 Feucherolles, France. Electronic address: jean-marie.grouin@univ-rouen.fr.
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Grouin
authors.affiliation: AP-HP, Hôpitaux Universitaires Paris-Sud, hôpital Antoine-Béclère, Département d'Anesthésie-Réanimation, 157, rue de la Porte-Trivaux, 92140 Clamart, France. Electronic address: frederic.mercier@abc.aphp.fr.
authors.forename: Frédéric J
authors.initials: FJ
authors.lastname: Mercier
mesh_terms: D000293:Adolescent; D000328:Adult; D001778:Blood Coagulation Disorders / Q000188:drug therapy*; D036861:Delivery, Obstetric; D015232:Dinoprostone / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005340:Fibrinogen / Q000009:adverse effects / Q000627:therapeutic use*; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008991:Monitoring, Physiologic; D010120:Oxytocics; D010121:Oxytocin; D061214:Patient Safety; D006473:Postpartum Hemorrhage / Q000188:drug therapy*; D011247:Pregnancy; D011446:Prospective Studies; D017211:Treatment Failure; D055815:Young Adult
chemical_list: D006490:Hemostatics; D010120:Oxytocics; D010121:Oxytocin; C016767:sulprostone; D005340:Fibrinogen; D015232:Dinoprostone
keywords: Blood transfusion; Fibrinogen concentrate; Postpartum haemorrhage