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Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study

NCT ID: NCT04194619

Last Updated: 2024-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-06

Study Completion Date

2028-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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.

* Major under legal protection
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie DUPUIS-GIROD, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Génétique - Hôpital Femme-Mère-Enfant - HCL

Locations

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Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers

Angers, , France

Site Status RECRUITING

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

Bordeaux, , France

Site Status RECRUITING

Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Site Status RECRUITING

Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon

Bron, , France

Site Status RECRUITING

Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL

Bron, , France

Site Status RECRUITING

Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL

Bron, , France

Site Status RECRUITING

Service de Génétique, Hôpital Femme-Mère-Enfant

Bron, , France

Site Status RECRUITING

Service de Médecine Vasculaire - Hôpital de la Côte de Nacre

Caen, , France

Site Status RECRUITING

Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing

Clermont-Ferrand, , France

Site Status RECRUITING

CHU Dijon Bourgogne - Hôpital François Mitterrand

Dijon, , France

Site Status RECRUITING

Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille

Lille, , France

Site Status RECRUITING

Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez

Lille, , France

Site Status RECRUITING

CHU de Marseille - Hôpital de la Timone

Marseille, , France

Site Status RECRUITING

Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier

Montpellier, , France

Site Status RECRUITING

Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien

Nancy, , France

Site Status RECRUITING

Service de Médecine Interne-Médecine Vasculaire, CHU de Nantes - Hôtel Dieu

Nantes, , France

Site Status RECRUITING

Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2

Nice, , France

Site Status RECRUITING

Service de dermatologie, CHU de Nice - Hôpital l'Archet 2

Nice, , France

Site Status RECRUITING

Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière)

Paris, , France

Site Status RECRUITING

Service de Lymphologie - Hôpital Cognacq-Jay - Paris

Paris, , France

Site Status RECRUITING

Service de Cardiologie - Hôpital Bichat, AP-HP

Paris, , France

Site Status RECRUITING

Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild

Paris, , France

Site Status RECRUITING

Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP

Paris, , France

Site Status RECRUITING

Service de Génétique CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou

Rennes, , France

Site Status RECRUITING

Unité de Génétique médicale, CHU de Rennes, Hôpital Sud

Rennes, , France

Site Status RECRUITING

Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle

Rouen, , France

Site Status RECRUITING

Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord

Saint-Etienne, , France

Site Status RECRUITING

Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC

Saint-Herblain, , France

Site Status RECRUITING

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

Strasbourg, , France

Site Status RECRUITING

CHU de Strasbourg, Hôpital de Hautepierre

Strasbourg, , France

Site Status RECRUITING

Service de Neuroradiologie Interventionnelle - Hôpital Foch

Suresnes, , France

Site Status RECRUITING

Service de Cardiologie _ Hôpital des Enfants (Purpan)

Toulouse, , France

Site Status RECRUITING

Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL

Toulouse, , France

Site Status RECRUITING

Service Pneumologie, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de TOURS

Tours, , France

Site Status RECRUITING

CHU de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie DUPUIS-GIROD, MD

Role: CONTACT

[email protected]
04 27 85 65 25 ext. +33

Amal AYADI ROBERT

Role: CONTACT

[email protected]
04 27 85 66 03 ext. +33

Facility Contacts

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Christian LAVIGNE, Dr

Role: primary

[email protected]
02 41 35 77 00 ext. +33

Matthieu DELION, Dr

Role: backup

[email protected]
02 41 35 48 21 ext. +33

Anne CONTIS, MD

Role: primary

05 56 79 58 28 ext. +33

Sandra BLIVET, MD

Role: primary

[email protected]
01 49 09 44 32 ext. +33

Sophie DUPUIS-GIROD

Role: primary

[email protected]
04 27 85 65 25 ext. +33

Amal AYADI ROBERT

Role: backup

[email protected]
04 27 85 66 03 ext. +33

Omer EKER, Dr

Role: primary

[email protected]
04 72 11 93 73 ext. +33

Laurent GUIBAUD, Pr

Role: primary

[email protected]
04 27 85 57 72 ext. +33

Alexandre GUILHEM, MD

Role: primary

[email protected]
04 27 85 65 25 ext. +33

Laurent CHAUSSAVOINE, MD

Role: primary

[email protected]
02 31 06 53 27 ext. +33

Vincent GROBOST, MD

Role: primary

[email protected]
04 73 75 00 85 ext. +33

Vanessa LEGUY-SEGUIN, MD

Role: primary

[email protected]
03 80 29 34 32 ext. +33

Pascal DELSART, MD

Role: primary

[email protected]
03 20 44 43 65 ext. +33

Hélène MAILLARD, MD

Role: primary

[email protected]
03 20 44 50 48 ext. +33

Baptiste ANDRE, MD

Role: primary

[email protected]
04 91 38 89 90 ext. +33

Sophie RIVIERE, MD

Role: primary

[email protected]
04 67 33 73 32 ext. +33

Serge BRACARD, MD-PhD

Role: primary

[email protected]
03 83 85 17 73 ext. +33

Olivier ESPITIA, MD

Role: primary

[email protected]
02 40 08 33 55 ext. +33

Jacques SEDAT, MD

Role: primary

[email protected]
04.92.03.38.07 ext. +33

Christine CHIAVERINI, MD

Role: primary

[email protected]
04.92.03.92.11 ext. +33

Annouk BISDORFF-BRESSON, MD

Role: primary

[email protected]
01 49 95 83 59 ext. +33

Stéphane VIGNES, MD

Role: primary

[email protected]
01 45 30 81 83 ext. +33

Guillaume JONDEAU, MD-PhD

Role: primary

[email protected]
01 40 25 68 11 ext. +33

Stanislas SMAJDA, MD

Role: primary

[email protected]
01 48 03 65 65 ext. +33

Antoine PARROT, MD

Role: primary

[email protected]
01 56 01 76 29 ext. +33

Xavier LE GUILLOU-HORN, MD

Role: primary

[email protected]
05 49 44 39 22 ext. +33

Mallorie KERJOUAN, MD

Role: primary

[email protected]
02 99 28 37 38 ext. +33

Sylvie ODENT, MD-PhD

Role: primary

[email protected]
02 99 26 67 44 ext. +33

Ygal BENHAMOU, MD

Role: primary

[email protected]

Claire LE HELLO, MD-PhD

Role: primary

[email protected]
04.77.82.94.24 ext. +33

Laurianne LE GLOAN, MD

Role: primary

[email protected]
02 40 08 33 33 ext. +33

Dominique STEPHAN, MD-PhD

Role: primary

[email protected]
03 69 55 05 36 ext. +33

Murielle RONDEAU-LUTZ, MD

Role: primary

[email protected]
03 88 12 81 25 ext. +33

Georges RODESCH, MD

Role: primary

[email protected]
01 46 25 26 60 ext. +33

Yves DULAC, MD

Role: primary

[email protected]
05 34 55 85 96 ext. +33

Laurent ALRIC, MD-PhD

Role: primary

[email protected]
05 61 32 35 95 ext. +33

Alessandra BURA-RIVIERE, Pr

Role: backup

[email protected]
05 61 32 24 38 ext. +33

Pascal MAGRO, MD

Role: primary

[email protected]
02 47 47 37 87 ext. +33

Shirine MOHAMED, MD

Role: primary

[email protected]
03 83 15 41 43 ext. +33

Other Identifiers

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69HCL19_0380

Identifier Type: -

Identifier Source: org_study_id

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