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Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial.
Ducloy-Bouthors, A S *,1,2; Mercier, F J 3,+; Grouin, J M 4; Bayoumeu, F 5; Corouge, J 1; Le Gouez, A 3; Rackelboom, T 6; Broisin, F 7; Vial, F 8; Luzi, A 9; Capronnier, O 10; Huissoud, C 7,11,+; Mignon, A 6,+; the FIDEL working group
[Miscellaneous] BJOG: An International Journal of Obstetrics & Gynaecology.

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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.