Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial.
Adult
Blood Transfusion
/ statistics & numerical data
Delivery, Obstetric
/ adverse effects
Double-Blind Method
Female
Fibrinogen
/ administration & dosage
Hemostatics
/ administration & dosage
Humans
Oxytocics
/ administration & dosage
Oxytocin
/ administration & dosage
Postpartum Hemorrhage
/ drug therapy
Pregnancy
Prostaglandins
/ administration & dosage
Secondary Prevention
Treatment Outcome
Vagina
Blood coagulation
erythrocyte transfusion
fibrinogen
postpartum haemorrhage
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
10 2021
10 2021
Historique:
received:
31
08
2020
accepted:
30
01
2021
pubmed:
14
3
2021
medline:
29
9
2021
entrez:
13
3
2021
Statut:
ppublish
Résumé
To assess the benefits and safety of early human fibrinogen concentrate in postpartum haemorrhage (PPH) management. Multicentre, double-blind, randomised placebo-controlled trial. 30 French hospitals. Patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins. Within 30 minutes after introduction of prostaglandins, patients received either 3 g fibrinogen concentrate or placebo. 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. 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. 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. Early systematic blind 3 g fibrinogen infusion in PPH did not reduce anaemia or transfusion rate, reduced hypofibrinogenaemia and was safe.
Identifiants
pubmed: 33713384
doi: 10.1111/1471-0528.16699
doi:
Substances chimiques
Hemostatics
0
Oxytocics
0
Prostaglandins
0
Oxytocin
50-56-6
Fibrinogen
9001-32-5
Banques de données
ClinicalTrials.gov
['NCT02155725']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1814-1823Subventions
Organisme : Laboratoire Fractionnement Biotechnologies
Investigateurs
Annie Amar-Millet
(A)
Catherine Barre-Drouard
(C)
Francis Bonnet
(F)
Martine Bonnin
(M)
Gilles Boulesteix
(G)
Adeline Castel
(A)
Mathilde Cattenoz
(M)
Dominique Chassard
(D)
Laurent Chonow
(L)
Catherine Copin-Eliat
(C)
Pierre-Auguste Diemunsch
(PA)
Marc Fischler
(M)
Max Gonzalez-Estevez
(M)
Hawa Keita-Meyer
(H)
Sigismond Lasocki
(S)
Agnès Lecinq
(A)
Jean-Marc Malinovsky
(JM)
Jihad Mallat
(J)
Jean-Christophe Mangin
(JC)
Estelle Morau
(E)
Nathalie Nathan
(N)
Agnès Rigouzzo
(A)
Sandrine Roger-Christoph
(S)
Lucie Sabau
(L)
Patrick Sinda
(P)
Mickael Soued
(M)
Nadia Steer
(N)
Stéphanie Tissier
(S)
Jean Tourres
(J)
Charlotte Vermersch
(C)
Informations de copyright
© 2021 John Wiley & Sons Ltd.
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