Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04194619

Collaborator

(none)

400

Enrollment

Locations

Anticipated Duration (Months)

12.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Anomaly Osler Rendu Disease Marfan Syndrome Lymphedema Primary Arteriovenous Malformations Cerebrospinal; Disorder	Other: Questionnaire

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Outcome Measures

Primary Outcome Measures

Occurrence of obstetrical complications among patients with rare vascular anomalies. [Maximum 21 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers	Angers	France	49933
2	Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux	Bordeaux	France	33075
3	Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré	Boulogne-Billancourt	France	92104
4	Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon	Bron	France	69677
5	Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL	Bron	France	69677
6	Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL	Bron	France	69677
7	Service de Médecine Vasculaire - Hôpital de la Côte de Nacre	Caen	France	14033
8	Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing	Clermont-Ferrand	France	63000
9	CHU Dijon Bourgogne - Hôpital François Mitterrand	Dijon	France
10	Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille	Lille	France	59037
11	Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez	Lille	France	59037
12	CHU de Marseille - Hôpital de la Timone	Marseille	France	13385
13	Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier	Montpellier	France	34295
14	Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien	Nancy	France	54035
15	Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2	Nice	France	06001
16	Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière)	Paris	France	75010
17	Service de Lymphologie - Hôpital Cognacq-Jay - Paris	Paris	France	75015
18	Service de Cardiologie - Hôpital Bichat, AP-HP	Paris	France	75018
19	Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild	Paris	France	75019
20	Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP	Paris	France
21	Service de Génétique CHU de Poitiers	Poitiers	France	86021
22	Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou	Rennes	France	35033
23	Unité de Génétique médicale, CHU de Rennes, Hôpital Sud	Rennes	France	35203
24	Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle	Rouen	France	76000
25	Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC	Saint-Herblain	France	44800
26	Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord	Saint-Étienne	France	42055
27	Service de Génétique Médicale, Hôpital de Hautepierre	Strasbourg	France	67098
28	Service de Neuroradiologie Interventionnelle - Hôpital Foch	Suresnes	France	92151
29	Service de Cardiologie _ Hôpital des Enfants (Purpan)	Toulouse	France	31026
30	Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL	Toulouse	France	31059
31	Service Pneumologie + Service de Dermatologie _ Hôpital Bretonneau Centre Hospitalier Régional Universitaire de TOURS	Tours	France
32	CHU de Nancy - Hôpitaux de Brabois	Vandœuvre-lès-Nancy	France	54511