Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
448 participants
INTERVENTIONAL
2014-04-10
2018-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Human Fibrinogen concentrate
2 vials (200ml) / 3g intravenous
Human Fibrinogen concentrate
Injection as soon as possible and within 30 min following the start of prostaglandin infusion
Placebo
2 vials (200ml)
Placebo
As soon as possible and within 30 min following the start of prostaglandin infusion
Interventions
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Human Fibrinogen concentrate
Injection as soon as possible and within 30 min following the start of prostaglandin infusion
Placebo
As soon as possible and within 30 min following the start of prostaglandin infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Vaginal delivery
* PPH requiring IV administration of prostaglandins
* At least one available result of Hb level during the third trimester of pregnancy
* 18-year-old female patients and older
* Covered by healthcare insurance in accordance with local requirements
Exclusion Criteria
* Haemostatic intervention (as ligation, embolization or hysterectomy) already decided at the time of inclusion
* Known placenta praevia or accreta
* Hb level \< 10g/dl during the third trimester of pregnancy
* History of venous or arterial thromboembolic event
* Known inherited bleeding or thrombotic disorders
* Treatment with low-molecular-weight heparin (LMWH) within 24 hours prior to the inclusion
* Treatment with acetylsalicylic acid within 5 days prior to the inclusion
* Treatment with vitamin K antagonists within 7 days prior to the inclusion
* Administration of fibrinogen concentrate within 48 hours prior to the inclusion
* Administration of FFP, platelets units or prohaemostatic drugs, tranexamic acid and rFVIIa or prothrombin complex concentrates (PCC) within 48 hours prior to the inclusion
* Administration of RBCs within 3 months prior to the inclusion
* Participation in another interventional clinical study within 30 days prior to the inclusion
* Previous inclusion/enrolment in the present clinical study
* Known history of hypersensitivity or other severe reaction to any component of Clottafact® or placebo
* Minors, majors under guardianship, persons staying in health or social institutes and people deprived of their freedom
* Known drug or alcohol abuse
* Patients whose use of concomitant medication may interfere with the interpretation of data
* Any other current significant medical condition that might interfere with treatment evaluation according to the investigator's judgement
* Patients who are unlikely to survive through the treatment period and evaluation
* Patients transferred from another service
18 Years
FEMALE
No
Sponsors
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Laboratoire français de Fractionnement et de Biotechnologies
INDUSTRY
Responsible Party
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Principal Investigators
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Anne-Sophie DUCLOY-BOUTHORS, Dr
Role: PRINCIPAL_INVESTIGATOR
Maternité Jeanne de Flandre - 59037 LILLE
Frédéric MERCIER, Pr
Role: STUDY_CHAIR
Hôpital Antoine Béclère - 92140 CLAMART
Alexandre MIGNON, Pr
Role: STUDY_CHAIR
Hôpital Cochin - 75014 PARIS
Cyril HUISSOUD, Pr
Role: STUDY_CHAIR
Hôpital Croix Rousse - 69004 LYON
Jean-Marie GROUIN
Role: STUDY_CHAIR
Université de Rouen - 76100 ROUEN
Locations
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CH Félix Guyon
Saint-Denis, Réunion, France
Groupe Hospitalier Sud Réunion
Saint-Pierre, Réunion, France
CHU d'Angers
Angers, , France
Hôpital Privé d'Antony
Antony, , France
Centre Hospitalier Fleyriat
Bourg-en-Bresse, , France
Hôpital Femme Mère Enfant
Bron, , France
Hôpital Antoine Béclère
Clamart, , France
CHU Estaing
Clermont-Ferrand, , France
Hôpital Louis Mourier
Colombes, , France
Les Hôpitaux de Chartres (Hôpital Pasteur)
Le Coudray, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Centre Hospitalier de Lens
Lens, , France
CHU de Lille, Maternité Jeanne de Flandre
Lille, , France
CHU de Limoges
Limoges, , France
Hôpital de la Croix Rousse
Lyon, , France
Hôpital Saint-Joseph / Pôle Parents - Enfants
Marseille, , France
CHRU de Montpellier
Montpellier, , France
Maternité Régionale Universitaire de Nancy
Nancy, , France
Hôpital Necker - Enfants malades
Paris, , France
Hôpital Armand Trousseau
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Tenon
Paris, , France
CHU de Reims, Hôpital Maison Blanche
Reims, , France
CHU de Rennes - Hôpital Sud
Rennes, , France
Polyclinique de l'Atlantique
Saint-Herblain, , France
Hôpital de Hautepierre
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Hôpital Paul de Viguier - Site Purpan
Toulouse, , France
CHU de Tours
Tours, , France
CH de Valenciennes
Valenciennes, , France
CHR de Martinique
Fort-de-France, , Martinique
Countries
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References
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Ducloy-Bouthors AS, Mercier FJ, Grouin JM, Bayoumeu F, Corouge J, Le Gouez A, Rackelboom T, Broisin F, Vial F, Luzi A, Capronnier O, Huissoud C, Mignon A; FIDEL working group. Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial. BJOG. 2021 Oct;128(11):1814-1823. doi: 10.1111/1471-0528.16699. Epub 2021 Apr 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2013-002484-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FIDEL
Identifier Type: -
Identifier Source: org_study_id
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