Fibrinogen in Haemorrhage of Delivery
FIDEL
Study on the Efficacy and Safety of a Therapeutic Strategy of PPH Comparing Early Administration of Human Fibrinogen vs Placebo in Patients Treated With IV Prostaglandins Following Vaginal Delivery
2 other identifiers
interventional
448
2 countries
31
Brief Summary
The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2014
Longer than P75 for phase_4
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2014
CompletedFirst Submitted
Initial submission to the registry
May 20, 2014
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2018
CompletedResults Posted
Study results publicly available
September 25, 2020
CompletedSeptember 25, 2020
July 1, 2020
4.3 years
May 20, 2014
June 8, 2020
September 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Failure Rate of PPH Management
The primary efficacy variable is a binary (Failure versus Success) composite endpoint. Failure is defined when a patient: * loses at least 4 g/dL of Hb compared to the reference Hb level , AND/OR * requires the transfusion of at least 2 units of packed RBCs.
Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration
Secondary Outcomes (2)
Patients With at Least Administration of 2 Units of RBCs
from H0 to Day 2
Patients With Loss of at Least 4 g/dL of Hb
From reference value to Day 2
Study Arms (2)
Human Fibrinogen concentrate
EXPERIMENTAL2 vials (200ml) / 3g intravenous
Placebo
PLACEBO COMPARATOR2 vials (200ml)
Interventions
Injection as soon as possible and within 30 min following the start of prostaglandin infusion
As soon as possible and within 30 min following the start of prostaglandin infusion
Eligibility Criteria
You may qualify if:
- Signed and dated informed consent form
- Vaginal delivery
- PPH requiring IV administration of prostaglandins
- At least one available result of Hb level during the third trimester of pregnancy
- year-old female patients and older
- Covered by healthcare insurance in accordance with local requirements
You may not qualify if:
- Caesarean section
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
CH Félix Guyon
Saint-Denis, Réunion, 97405, France
Groupe Hospitalier Sud Réunion
Saint-Pierre, Réunion, 97448, France
CHU d'Angers
Angers, 49933, France
Hôpital Privé d'Antony
Antony, 92160, France
Centre Hospitalier Fleyriat
Bourg-en-Bresse, 01012, France
Hôpital Femme Mère Enfant
Bron, 69500, France
Hôpital Antoine Béclère
Clamart, 92141, France
CHU Estaing
Clermont-Ferrand, 63000, France
Hôpital Louis Mourier
Colombes, 92701, France
Les Hôpitaux de Chartres (Hôpital Pasteur)
Le Coudray, 28630, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275, France
Centre Hospitalier de Lens
Lens, 62307, France
CHU de Lille, Maternité Jeanne de Flandre
Lille, 59037, France
CHU de Limoges
Limoges, 87042, France
Hôpital de la Croix Rousse
Lyon, 69004, France
Hôpital Saint-Joseph / Pôle Parents - Enfants
Marseille, 13008, France
CHRU de Montpellier
Montpellier, 34295, France
Maternité Régionale Universitaire de Nancy
Nancy, 54042, France
Hôpital Necker - Enfants malades
Paris, 75015, France
Hôpital Armand Trousseau
Paris, 75571, France
Hôpital Cochin
Paris, 75679, France
Hôpital Tenon
Paris, 75970, France
CHU de Reims, Hôpital Maison Blanche
Reims, 51092, France
CHU de Rennes - Hôpital Sud
Rennes, 35203, France
Polyclinique de l'Atlantique
Saint-Herblain, 44819, France
Hôpital de Hautepierre
Strasbourg, 67200, France
Hôpital Foch
Suresnes, 92151, France
Hôpital Paul de Viguier - Site Purpan
Toulouse, 31059, France
CHU de Tours
Tours, 37044, France
CH de Valenciennes
Valenciennes, 59300, France
CHR de Martinique
Fort-de-France, 97261, Martinique
Related Publications (1)
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.
PMID: 33713384DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director France
- Organization
- LFB Biomédicaments
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Sophie DUCLOY-BOUTHORS, Dr
Maternité Jeanne de Flandre - 59037 LILLE
- STUDY CHAIR
Frédéric MERCIER, Pr
Hôpital Antoine Béclère - 92140 CLAMART
- STUDY CHAIR
Alexandre MIGNON, Pr
Hôpital Cochin - 75014 PARIS
- STUDY CHAIR
Cyril HUISSOUD, Pr
Hôpital Croix Rousse - 69004 LYON
- STUDY CHAIR
Jean-Marie GROUIN
Université de Rouen - 76100 ROUEN
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2014
First Posted
June 4, 2014
Study Start
April 10, 2014
Primary Completion
August 6, 2018
Study Completion
August 6, 2018
Last Updated
September 25, 2020
Results First Posted
September 25, 2020
Record last verified: 2020-07