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Early and Systematic Administration of Fibrinogen Concentrate in Postpartum Haemorrhage Following Vaginal Delivery: The FIDEL Randomized Controlled Trial

Pole anesthésie réanimation, maternité Jeanne de Flandre, CHRU Lille, France. ULR 7365 Université Lille, France. Hôpital Antoine Béclère, Assistance Publique Hôpitaux de Paris, Clamart, France. Inserm U1219, Population Health, Bordeaux, France. Hôpital Paule de Viguier, CHU Toulouse, Toulouse, France. Hôpital Cochin, Assistance Publique Hôpitaux de Paris, Paris, France. Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France. Maternité Adolphe Pinard, CHU de Nancy, Nancy, France. CHU Sud. St Pierre-de-la-Réunion, France. Euraxi Pharma, France. INSERM U846, Stem Cell and Brain Research Institute, Bron, France.

BJOG : an international journal of obstetrics and gynaecology. 2021
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PICO Summary

Population

Patients with persistent post-partum haemorrhage after vaginal delivery enrolled in the FIDEL trial (n= 437).

Intervention

Fibrinogen concentrate (n= 224).

Comparison

Placebo (n = 213).

Outcome

At inclusion, blood loss (877 ± 346mL) and plasma fibrinogen (4.1 ± 0.9g/L) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively after adjustment for centre and baseline plasma fibrinogen. No significant differences in secondary efficacy outcomes were observed. The mean plasma fibrinogen 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.
Abstract
OBJECTIVE To assess the benefits and safety of early human fibrinogen concentrate 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 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 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 437 patients were included : 224 received FC and 213 placebo. At inclusion, blood loss (877 ± 346mL) and plasma fibrinogen (4.1 ± 0.9g/L) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the Fibrinogen and placebo groups, respectively (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, and postpartum anaemia, but prevented plasma fibrinogen decrease without any subsequent thromboembolic events.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine