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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

Corresponding Author:[email protected]

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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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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.
31 Aug 2020Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
01 Sep 2020Submission Checks Completed
01 Sep 2020Assigned to Editor
08 Sep 2020Reviewer(s) Assigned
16 Sep 2020Review(s) Completed, Editorial Evaluation Pending
05 Oct 2020Editorial Decision: Revise Major
13 Nov 20201st Revision Received
27 Nov 2020Submission Checks Completed
27 Nov 2020Assigned to Editor
03 Dec 2020Review(s) Completed, Editorial Evaluation Pending
14 Dec 2020Editorial Decision: Revise Minor
23 Dec 20202nd Revision Received
23 Dec 2020Submission Checks Completed
23 Dec 2020Assigned to Editor
03 Jan 2021Review(s) Completed, Editorial Evaluation Pending
30 Jan 2021Editorial Decision: Accept