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Cited by 88Maternal and fetal healthcareBlood transfusion and managementHemostasis and retained surgical items

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

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Ducloy‐Bouthors, AS, Mercier, FJ, Grouin, JM, Bayoumeu, F, Corouge, J, Le Gouez, A, Rackelboom, T, Broisin, F +6 more·2021·BJOG: An International Journal of Obstetrics & Gynaecology
DOI 10.1111/1471-0528.16699

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Abstract

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.

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Authors
Ducloy‐Bouthors, A., Mercier, F., Grouin, J., Bayoumeu, F., Corouge, J., Le Gouez, A., Rackelboom, T., Broisin, F., Vial, F., Luzi, A., Capronnier, O., Huissoud, C., Mignon, A., & the FIDEL working group
Affiliations
  • Université de Lille (FR)
  • Hôpital Antoine Béclère Assistance Publique Hôpitaux de Paris Clamart France
  • Inserm U1219, Population Health Bordeaux France
  • Hôpital Paule de Viguier (FR)
  • Centre Hospitalier Universitaire de Lille (FR)
  • Hôpital Cochin (FR)
  • Hôpital de la Croix-Rousse (FR)
  • Centre Hospitalier Régional et Universitaire de Nancy (FR)
  • CHU Sud St Pierre‐de‐la‐Réunion France
  • Euraxi Pharma (France) (FR)
  • Inserm (FR)
Corresponding author
Ducloy‐Bouthors, AS
ORCID
Venue
BJOG: An International Journal of Obstetrics & Gynaecology
Publisher
Wiley
Published
2021-04-07
Volume
128
Issue
11
Pages
1814-1823
ISSN
  • 0306-5456 (ISSN-L)
  • 1470-0328
  • 1471-0528
DOI
10.1111/1471-0528.16699
OpenAlex
W3134568807
Cited by
88
References
32
Citations by year
2026: 21 · 2025: 13 · 2024: 21 · 2023: 17 · 2022: 14 · 2021: 2
FWCI
13.34
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • BJOG An International Journal of Obstetrics & Gynaecology (publishedVersion)
  • PubMed (publishedVersion)
  • HAL (submittedVersion)
  • Oskar-Bordeaux (Universite de Bordeaux) (submittedVersion)
Topics
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Maternal and fetal healthcare
  • Health Sciences › Medicine › Biochemistry › Blood transfusion and management
  • Health Sciences › Medicine › Hematology › Hemostasis and retained surgical items
Keywords
fibrinogen concentrate, postpartum hemorrhage, vaginal delivery, fibrinogen, hypofibrinogenemia, blood transfusion, postpartum anemia, oxytocin, prostaglandins
MeSH terms
Adult, Blood Transfusion, Double-Blind Method, Female, Fibrinogen, Postpartum Hemorrhage, Hemostatics, Humans, Oxytocics, Oxytocin, Pregnancy, Prostaglandins, Vagina, Treatment Outcome, Delivery, Obstetric, Secondary Prevention

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