Marfan Syndrome Clinical Trial
— COGRare5Official title:
A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study
There are no prospective studies of pregnancies for the diseases studied here in (Heredity
Hemorrhagic Telangiectasia, Marfan syndrome, primary lower limb lymphedema, superficial
arteriovenous malformations, and cerebro-spinal arteriovenous malformations) although
complications of these can present life-threatening health problems for the mother and her
baby.
The purpose of this National prospective study is to obtain greater insight into obstetrical
complications associated with rare maternal vascular genetic disorders in order to improve
prevention and to reduce risk of death.
In this context, experts and patient associations consider that there is a need to make real
progress in the formulation of recommendations based on scientific data.
| Status | Not yet recruiting |
| Enrollment | 400 |
| Est. completion date | September 2026 |
| Est. primary completion date | September 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Women aged = 18 years and =45 years at the time of inclusion - Pregnant and/or having given birth less than 1 month (= 30 days) - Clinically and/or radiological and/or molecular biology diagnosis of a rare vascular disease before or during pregnancy or one month after delivery. - Having been informed of all pertinent aspects of the study and provided oral non-opposition. Exclusion Criteria: - Any person not fulfilling the inclusion criteria or refusing to take part in the study. - Major under legal protection |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers | Angers | |
| France | Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux | Bordeaux | |
| France | Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré | Boulogne-Billancourt | |
| France | Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon | Bron | |
| France | Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL | Bron | |
| France | Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL | Bron | |
| France | Service de Médecine Vasculaire - Hôpital de la Côte de Nacre | Caen | |
| France | Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing | Clermont-Ferrand | |
| France | CHU Dijon Bourgogne - Hôpital François Mitterrand | Dijon | |
| France | Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille | Lille | |
| France | Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez | Lille | |
| France | CHU de Marseille - Hôpital de la Timone | Marseille | |
| France | Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier | Montpellier | |
| France | Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien | Nancy | |
| France | Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2 | Nice | |
| France | Service de Cardiologie - Hôpital Bichat, AP-HP | Paris | |
| France | Service de Lymphologie - Hôpital Cognacq-Jay - Paris | Paris | |
| France | Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière) | Paris | |
| France | Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild | Paris | |
| France | Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP | Paris | |
| France | Service de Génétique CHU de Poitiers | Poitiers | |
| France | Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou | Rennes | |
| France | Unité de Génétique médicale, CHU de Rennes, Hôpital Sud | Rennes | |
| France | Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle | Rouen | |
| France | Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord | Saint-Étienne | |
| France | Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC | Saint-Herblain | |
| France | Service de Génétique Médicale, Hôpital de Hautepierre | Strasbourg | |
| France | Service de Neuroradiologie Interventionnelle - Hôpital Foch | Suresnes | |
| France | Service de Cardiologie _ Hôpital des Enfants (Purpan) | Toulouse | |
| France | Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL | Toulouse | |
| France | Service Pneumologie + Service de Dermatologie _ Hôpital Bretonneau Centre Hospitalier Régional Universitaire de TOURS | Tours | |
| France | CHU de Nancy - Hôpitaux de Brabois | Vandœuvre-lès-Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurrence of obstetrical complications among patients with rare vascular anomalies. | The primary effectiveness endpoint is the occurrence of specific and serious obstetrical complications during and after the pregnancy period among patients with rare vascular anomalies. The questionnaire consists in collecting obstetric complications (interview time is about 15 minutes) every 3 months during and after pregnancy. |
Maximum 21 months |
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