Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study
COGRare5
A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study
1 other identifier
observational
400
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 11, 2019
CompletedStudy Start
First participant enrolled
February 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
March 11, 2026
March 1, 2026
7 years
December 9, 2019
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of obstetrical complications among patients with rare vascular anomalies.
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.
Every 3 months up to 21 months
Interventions
Interview of women with a rare vascular disease through a phone questionnaire about severe and specific obstetrical complications during and after pregnancy.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Major under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers
Angers, 49933, France
Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux
Bordeaux, 33075, France
Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré
Boulogne-Billancourt, 92104, France
Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon
Bron, 69677, France
Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL
Bron, 69677, France
Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL
Bron, 69677, France
Service de Génétique, Hôpital Femme-Mère-Enfant
Bron, 69677, France
Service de Médecine Vasculaire - Hôpital de la Côte de Nacre
Caen, 14033, France
Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing
Clermont-Ferrand, 63000, France
CHU Dijon Bourgogne - Hôpital François Mitterrand
Dijon, France
Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille
Lille, 59037, France
Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez
Lille, 59037, France
CHU de Marseille - Hôpital de la Timone
Marseille, 13385, France
Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier
Montpellier, 34295, France
Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien
Nancy, 54035, France
Service de Médecine Interne-Médecine Vasculaire, CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2
Nice, 06001, France
Service de dermatologie, CHU de Nice - Hôpital l'Archet 2
Nice, 06202, France
Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière)
Paris, 75010, France
Service de Lymphologie - Hôpital Cognacq-Jay - Paris
Paris, 75015, France
Service de Cardiologie - Hôpital Bichat, AP-HP
Paris, 75018, France
Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild
Paris, 75019, France
Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP
Paris, France
Service de Génétique CHU de Poitiers
Poitiers, 86021, France
Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
Unité de Génétique médicale, CHU de Rennes, Hôpital Sud
Rennes, 35203, France
Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle
Rouen, 76000, France
Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord
Saint-Etienne, 42055, France
Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC
Saint-Herblain, 44800, France
Service Maladies vasculaires - HTA - NHC Pôle Médico-chirurgicale cardio-vasculaire, CHU de Strasbourg - Hôpital Civil
Strasbourg, 67091, France
CHU de Strasbourg, Hôpital de Hautepierre
Strasbourg, 67200, France
Service de Neuroradiologie Interventionnelle - Hôpital Foch
Suresnes, 92151, France
Service de Cardiologie _ Hôpital des Enfants (Purpan)
Toulouse, 31026, France
Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL
Toulouse, 31059, France
Service Pneumologie, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de TOURS
Tours, 37044, France
CHU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie DUPUIS-GIROD, MD
Service de Génétique - Hôpital Femme-Mère-Enfant - HCL
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2019
First Posted
December 11, 2019
Study Start
February 6, 2020
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
November 1, 2028
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share