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Early and Systematic Administration of Fibrinogen Concentrate in Postpartum Haemorrhage Following Vaginal Delivery: The FIDEL Randomized Controlled Trial.
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  • Ducloy-Bouthors Ducloy-Bouthors,
  • Frederic Mercier,
  • Jean-Marie Grouin,
  • Francoise Bayoumeu,
  • Julien Corouge,
  • Agnes Le Gouez,
  • Thibaut Rackelboom,
  • Francoise Broisin,
  • Florence Vial,
  • Aymeric Luzi,
  • FIDEL Working group,
  • Cyril Huissoud,
  • Alexandre Mignon
Ducloy-Bouthors Ducloy-Bouthors
Centre Hospitalier Regional Universitaire de Lille
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Frederic Mercier
Hopital Antoine-Beclere
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Jean-Marie Grouin
Inserm U1219, Population Health. Bordeaux, France
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Francoise Bayoumeu
Centre Hospitalier Universitaire de Toulouse
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Julien Corouge
Centre Hospitalier Regional Universitaire de Lille
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Agnes Le Gouez
Hospital Antoine-Beclere
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Thibaut Rackelboom
Hospital Cochin
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Francoise Broisin
Hopital de la Croix-Rousse
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Florence Vial
Centre Hospitalier Universitaire de Nancy
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Aymeric Luzi
Centre Hospitalier Universitaire de la Reunion
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FIDEL Working group
Centre Hospitalier Universitaire de Lille
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Cyril Huissoud
Centre hospitalo universitaire de Lyon Croix-Rousse
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Alexandre Mignon
Hopital Cochin
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Abstract

Objective: To assess the benefits and safety of early human fibrinogen concentrate (FC) in postpartum haemorrhage (PPH) management. Design: Multicentre, double-blind, randomized placebo-controlled trial. Setting:30 French hospitals. Population: patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins. Methods: Within 30 min after introduction of prostaglandins, patients received either 3 g FC or placebo. Main outcome measures: Failure as composite primary efficacy endpoint: at least 4 g/dL of haemoglobin decrease and/or transfusion of at least 2 units of packed red blood cells within 48h following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures, and maternal morbidity-mortality within 6±2 weeks after delivery. Results: the intention-to-treat analysis included 437 patients of which 224 received FC and 213 placebo. At inclusion, blood loss (877 ± 346mL) and plasma fibrinogen (FG) (4.1 ± 0.9g/L) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the FC and placebo groups, respectively (OR=0.99) after adjustment on centre and baseline FG; (95%CI: [0.66;1.47]; p=0.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged after 2 hours in the FC group and decreased by 0.56 g/L in the placebo group. No thromboembolic or other relevant adverse effects were reported in the FC group, versus two in the placebo group. Conclusions: Early and systematic administration of 3 g fibrinogen concentrate did not reduce blood loss, transfusion needs, and postpartum anaemia, but prevented plasma fibrinogen decrease without any subsequent thromboembolic events.

Peer review status:UNDER REVIEW

31 Aug 2020Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
01 Sep 2020Assigned to Editor
01 Sep 2020Submission Checks Completed
08 Sep 2020Reviewer(s) Assigned
16 Sep 2020Review(s) Completed, Editorial Evaluation Pending