Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial
dc.rights.license | open | en_US |
dc.contributor.author | DUCLOY-BOUTHORS, Anne-Sophie | |
dc.contributor.author | MERCIER, Frederic J. | |
hal.structure.identifier | Bordeaux population health [BPH] | |
dc.contributor.author | GROUIN, Jean-Marie | |
dc.contributor.author | BAYOUMEU, Francoise | |
dc.contributor.author | COROUGE, Julien | |
dc.contributor.author | LE GOUEZ, Agnes | |
dc.contributor.author | RACKELBOOM, Thibaut | |
dc.contributor.author | BROISIN, Francoise | |
dc.contributor.author | VIAL, Florence | |
dc.contributor.author | LUZI, Aymeric | |
dc.contributor.author | CAPRONNIER, Odile | |
dc.contributor.author | HUISSOUD, Cyril | |
dc.contributor.author | MIGNON, Alexandre | |
dc.contributor.author | GROUP, Fidel Working | |
dc.date.accessioned | 2021-05-10T13:43:39Z | |
dc.date.available | 2021-05-10T13:43:39Z | |
dc.date.issued | 2021-03-13 | |
dc.identifier.issn | 1471-0528 (Electronic) 1470-0328 (Linking) | en_US |
dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/27233 | |
dc.description.abstractEn | 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. | |
dc.language.iso | EN | en_US |
dc.subject.en | Blood coagulation | |
dc.subject.en | Erythrocyte transfusion | |
dc.subject.en | Fibrinogen | |
dc.subject.en | Postpartum haemorrhage | |
dc.title.en | Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial | |
dc.type | Article de revue | en_US |
dc.identifier.doi | 10.1111/1471-0528.16699 | en_US |
dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
dc.identifier.pubmed | 33713384 | en_US |
bordeaux.journal | BJOG: An International Journal of Obstetrics and Gynaecology | en_US |
bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - U1219 | en_US |
bordeaux.institution | Université de Bordeaux | en_US |
bordeaux.institution | INSERM | en_US |
bordeaux.team | PharmacoEpi-Drugs | en_US |
bordeaux.peerReviewed | oui | en_US |
bordeaux.inpress | non | en_US |
hal.identifier | hal-03222996 | |
hal.version | 1 | |
hal.date.transferred | 2021-05-10T13:43:43Z | |
hal.export | true | |
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