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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04194619
Other study ID # 69HCL19_0380
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2020
Est. completion date September 2026

Study information

Verified date December 2019
Source Hospices Civils de Lyon
Contact Sophie DUPUIS-GIROD, Dr
Phone 04 27 85 65 25
Email sophie.dupuis-girod@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Questionnaire
Interview of women with a rare vascular disease through a phone questionnaire about severe and specific obstetrical complications during and after pregnancy.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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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