Clinical trial NCT04194619: Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study
Official title: A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Anomaly
Osler Rendu Disease
Marfan Syndrome or Related
Lymphedema Primary
Arteriovenous Malformations
Cerebrospinal; Disorder
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study describes severe and specific obstetrical complications during and after pregnancy (until 12 months postpartum) for the following pathologies: heredity hemorrhagic telangiectasia, marfan syndrome or related, primary lower limb lymphedema, superficial arteriovenous malformations or even cerebro-spinal arteriovenous malformations.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of obstetrical complications among patients with rare vascular anomalies.
timeFrame: Every 3 months up to 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers
city: Bordeaux
country: France
facility: Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux
city: Boulogne-Billancourt
country: France
facility: Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré
city: Bron
country: France
facility: Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon
city: Bron
country: France
facility: Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL
city: Bron
country: France
facility: Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL
city: Bron
country: France
facility: Service de Génétique, Hôpital Femme-Mère-Enfant
city: Caen
country: France
facility: Service de Médecine Vasculaire - Hôpital de la Côte de Nacre
city: Clermont-Ferrand
country: France
facility: Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing
city: Dijon
country: France
facility: CHU Dijon Bourgogne - Hôpital François Mitterrand
city: Lille
country: France
facility: Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille
city: Lille
country: France
facility: Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez
city: Marseille
country: France
facility: CHU de Marseille - Hôpital de la Timone
city: Montpellier
country: France
facility: Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier
city: Nancy
country: France
facility: Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien
city: Nantes
country: France
facility: Service de Médecine Interne-Médecine Vasculaire, CHU de Nantes - Hôtel Dieu
city: Nice
country: France
facility: Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2
city: Nice
country: France
facility: Service de dermatologie, CHU de Nice - Hôpital l'Archet 2
city: Paris
country: France
facility: Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière)
city: Paris
country: France
facility: Service de Lymphologie - Hôpital Cognacq-Jay - Paris
city: Paris
country: France
facility: Service de Cardiologie - Hôpital Bichat, AP-HP
city: Paris
country: France
facility: Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild
city: Paris
country: France
facility: Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP
city: Poitiers
country: France
facility: Service de Génétique CHU de Poitiers
city: Rennes
country: France
facility: Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou
city: Rennes
country: France
facility: Unité de Génétique médicale, CHU de Rennes, Hôpital Sud
city: Rouen
country: France
facility: Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle
city: Saint-Herblain
country: France
facility: Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC
city: Saint-Étienne
country: France
facility: Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: Service Maladies vasculaires - HTA - NHC Pôle Médico-chirurgicale cardio-vasculaire, CHU de Strasbourg - Hôpital Civil
city: Strasbourg
country: France
facility: CHU de Strasbourg, Hôpital de Hautepierre
city: Suresnes
country: France
facility: Service de Neuroradiologie Interventionnelle - Hôpital Foch
city: Toulouse
country: France
facility: Service de Cardiologie _ Hôpital des Enfants (Purpan)
city: Toulouse
country: France
facility: Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL
city: Tours
country: France
facility: Service Pneumologie, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de TOURS
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy - Hôpitaux de Brabois
Study officials:
affiliation: Service de Génétique - Hôpital Femme-Mère-Enfant - HCL
name: Sophie DUPUIS-GIROD, MD
role: PRINCIPAL_INVESTIGATOR
References: