Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial.
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.
['Ducloy-Bouthors|A S|AS|0000-0001-6478-1115', 'Mercier|F J|FJ|', 'Grouin|J M|JM|', 'Bayoumeu|F|F|', 'Corouge|J|J|', 'Le Gouez|A|A|', 'Rackelboom|T|T|', 'Broisin|F|F|', 'Vial|F|F|', 'Luzi|A|A|', 'Capronnier|O|O|', 'Huissoud|C|C|', 'Mignon|A|A|', '|||']
D000328:Adult D001803:Blood Transfusion D036861:Delivery, Obstetric D004311:Double-Blind Method D005260:Female D005340:Fibrinogen D006490:Hemostatics D006801:Humans D010120:Oxytocics D010121:Oxytocin D006473:Postpartum Hemorrhage D011247:Pregnancy D011453:Prostaglandins D055502:Secondary Prevention D016896:Treatment Outcome D014621:Vagina
fibrinogen postpartum haemorrhage Blood coagulation erythrocyte transfusion