Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study

Recruiting

• Conditions: Marfan Syndrome or Related; Arteriovenous Malformations; Cerebrospinal; Disorder; Osler Rendu Disease; Vascular Anomaly; Lymphedema Primary

• Registration Number: NCT04194619
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

There are no prospective studies of pregnancies for the diseases studied here in (Heredity Hemorrhagic Telangiectasia, Marfan syndrome or related, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Study Start: 2020-02-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2027-02
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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.

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Exclusion Criteria

• Any person not fulfilling the inclusion criteria or refusing to take part in the study.
• Major under legal protection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of obstetrical complications among patients with rare vascular anomalies.	Every 3 months up to 21 months	The primary outcome measure is the occurrence of specific and serious obstetrical complications during the pregnancy period and and after 12 months among patients with rare vascular anomalies, obtained via phone questionnaire.

Trial Locations

Locations (36)

Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL; 🇫🇷 Bron, France

Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers; 🇫🇷 Angers, 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 de Génétique, Hôpital Femme-Mère-Enfant; 🇫🇷 Bron, France

Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL; 🇫🇷 Bron, France

Service de Médecine Vasculaire - Hôpital de la Côte de Nacre; 🇫🇷 Caen, France

CHU Dijon Bourgogne - Hôpital François Mitterrand; 🇫🇷 Dijon, France

Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing; 🇫🇷 Clermont-Ferrand, France

Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille; 🇫🇷 Lille, France

Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier; 🇫🇷 Montpellier, France

CHU de Marseille - Hôpital de la Timone; 🇫🇷 Marseille, France

Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien; 🇫🇷 Nancy, France

Service de dermatologie, CHU de Nice - Hôpital l'Archet 2; 🇫🇷 Nice, France

Service de Lymphologie - Hôpital Cognacq-Jay - Paris; 🇫🇷 Paris, France

Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière); 🇫🇷 Paris, France

Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2; 🇫🇷 Nice, France

Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou; 🇫🇷 Rennes, France

Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP; 🇫🇷 Paris, France

Service de Génétique CHU de Poitiers; 🇫🇷 Poitiers, France

Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild; 🇫🇷 Paris, France

Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC; 🇫🇷 Saint-Herblain, France

Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord; 🇫🇷 Saint-Étienne, France

Service de Neuroradiologie Interventionnelle - Hôpital Foch; 🇫🇷 Suresnes, France

Service de Cardiologie _ Hôpital des Enfants (Purpan); 🇫🇷 Toulouse, France

Unité de Génétique médicale, CHU de Rennes, Hôpital Sud; 🇫🇷 Rennes, France

Service Pneumologie, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de TOURS; 🇫🇷 Tours, France

CHU de Nancy - Hôpitaux de Brabois; 🇫🇷 Vandœuvre-lès-Nancy, France

Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux; 🇫🇷 Bordeaux, France

Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez; 🇫🇷 Lille, France

Service de Médecine Interne-Médecine Vasculaire, CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

Service de Cardiologie - Hôpital Bichat, AP-HP; 🇫🇷 Paris, France

Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Service Maladies vasculaires - HTA - NHC Pôle Médico-chirurgicale cardio-vasculaire, CHU de Strasbourg - Hôpital Civil; 🇫🇷 Strasbourg, France

CHU de Strasbourg, Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL; 🇫🇷 Toulouse, France