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

dc.rights.licenseopenen_US
dc.contributor.authorDUCLOY-BOUTHORS, Anne-Sophie
dc.contributor.authorMERCIER, Frederic J.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorGROUIN, Jean-Marie
dc.contributor.authorBAYOUMEU, Francoise
dc.contributor.authorCOROUGE, Julien
dc.contributor.authorLE GOUEZ, Agnes
dc.contributor.authorRACKELBOOM, Thibaut
dc.contributor.authorBROISIN, Francoise
dc.contributor.authorVIAL, Florence
dc.contributor.authorLUZI, Aymeric
dc.contributor.authorCAPRONNIER, Odile
dc.contributor.authorHUISSOUD, Cyril
dc.contributor.authorMIGNON, Alexandre
dc.contributor.authorGROUP, Fidel Working
dc.date.accessioned2021-05-10T13:43:39Z
dc.date.available2021-05-10T13:43:39Z
dc.date.issued2021-03-13
dc.identifier.issn1471-0528 (Electronic) 1470-0328 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/27233
dc.description.abstractEnObjective: 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.isoENen_US
dc.subject.enBlood coagulation
dc.subject.enErythrocyte transfusion
dc.subject.enFibrinogen
dc.subject.enPostpartum haemorrhage
dc.title.enEarly and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial
dc.typeArticle de revueen_US
dc.identifier.doi10.1111/1471-0528.16699en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed33713384en_US
bordeaux.journalBJOG: An International Journal of Obstetrics and Gynaecologyen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03222996
hal.version1
hal.date.transferred2021-05-10T13:43:43Z
hal.exporttrue
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