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Randomized Controlled Trial
. 2021 Oct;128(11):1814-1823.
doi: 10.1111/1471-0528.16699. Epub 2021 Apr 7.

Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial

A S Ducloy-Bouthors  1   2 , F J Mercier  3 , J M Grouin  4 , F Bayoumeu  5 , J Corouge  1 , A Le Gouez  3 , T Rackelboom  6 , F Broisin  7 , F Vial  8 , A Luzi  9 , O Capronnier  10 , C Huissoud  7   11 , A Mignon  6 ; FIDEL working group
Collaborators, Affiliations
Randomized Controlled Trial

Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial

A S Ducloy-Bouthors et al. BJOG. 2021 Oct.

Abstract

Objective: To assess the benefits and safety of early human fibrinogen concentrate in postpartum haemorrhage (PPH) management.

Design: Multicentre, double-blind, randomised 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 minutes after introduction of prostaglandins, patients received either 3 g fibrinogen concentrate 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 two units of packed red blood cells within 48 hours following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures and maternal morbidity-mortality within 6 ± 2 weeks after delivery.

Results: 437 patients were included: 224 received FC and 213 placebo. At inclusion, blood loss (877 ± 346 ml) and plasma fibrinogen (4.1 ± 0.9 g/l) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively (odds ratio [OR] = 0.99) after adjustment for centre and baseline plasma fibrinogen; (95% CI 0.66-1.47; P = 0.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged in the Fibrinogen group and decreased by 0.56 g/l in the placebo group. No thromboembolic or other relevant adverse effects were reported in the Fibrinogen group versus two in the placebo group.

Conclusions: As previous placebo-controlled studies findings, early and systematic administration of 3 g fibrinogen concentrate did not reduce blood loss, transfusion needs or postpartum anaemia, but did prevent plasma fibrinogen decrease without any subsequent thromboembolic events.

Tweetable abstract: Early systematic blind 3 g fibrinogen infusion in PPH did not reduce anaemia or transfusion rate, reduced hypofibrinogenaemia and was safe.

Trial registration: ClinicalTrials.gov NCT02155725.

Keywords: Blood coagulation; erythrocyte transfusion; fibrinogen; postpartum haemorrhage.

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References

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    1. Sentilhes L, Vayssière C, Mercier FJ, Aya AG, Bayoumeu F, Bonnet MP, et al. Postpartum hemorrhage: Guidelines for clinical practice-text of the Guidelines (short text). J Gynecol Obstet Biol Reprod 2014;43:1170-9.
    1. Ring L, Landau R. Postpartum hemorrhage: anesthesia management. Semin Perinatol 2019;43:35-43.

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