Vascular AnomalyCOGRare5NCT04194619
Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study
An observational study of Vascular Anomaly and Osler Rendu Disease, run by Hospices Civils de Lyon at 37 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vascular Anomaly, Osler Rendu Disease, Marfan Syndrome or Related
- What is being tested?
- Questionnaire
- How many people
- 400 participants
- Where
- 37 sitesFrance
- Study dates
- 6 Feb 2020to Nov 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Any person not fulfilling the inclusion criteria or refusing to take part in the study.
- Major under legal protection
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
France37 sites, 32 recruiting
- Recruiting
Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers
Angers, 49933
Christian LAVIGNE, Dr, 02 41 35 77 00 ext. +33, chlavigne@chu-angers.fr
Matthieu DELION, Dr, 02 41 35 48 21 ext. +33, madelion@chu-angers.fr
- Withdrawn
Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux
Bordeaux, 33075
- Not yet recruiting
CHU de Bordeaux - Groupe Hospitalier Pellegrin Service de Radiologie et de neuro-imagerie
Bordeaux, 33076
Xavier BARREAU, Dr, 05 40 45 12 00 ext. +33, xavier.barreau@chu-bordeaux.fr
Xavier BARREAU, Dr
- Recruiting
Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré
Boulogne-Billancourt, 92104
Sandra BLIVET, MD, 01 49 09 44 32 ext. +33, Sandra.blivet@aphp.fr
Sandra BLIVET, MD
- Recruiting
Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon
Bron, 69677
Sophie DUPUIS-GIROD, 04 27 85 65 25 ext. +33, sophie.dupuis-girod@chu-lyon.fr
Amal AYADI ROBERT, 04 27 85 66 03 ext. +33, amal.ayadi@chu-lyon.fr
- Withdrawn
Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL
Bron, 69677
- Recruiting
Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL
Bron, 69677
Laurent GUIBAUD, Pr, 04 27 85 57 72 ext. +33, laurent.guibaud@chu-lyon.fr
- Recruiting
Service de Génétique, Hôpital Femme-Mère-Enfant
Bron, 69677
Alexandre GUILHEM, MD, 04 27 85 65 25 ext. +33, alexandre.guilhem@chu-lyon.fr
Alexandre GUILHEM
- Recruiting
Service de Médecine Vasculaire - Hôpital de la Côte de Nacre
Caen, 14033
Laurent CHAUSSAVOINE, MD, 02 31 06 53 27 ext. +33, chaussavoine-l@chu-caen.fr
Damien LANEELLE, MD
- Recruiting
Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing
Clermont-Ferrand, 63000
Vincent GROBOST, MD, 04 73 75 00 85 ext. +33, vgrobost@chu-clermontferrand.fr
Vincent GROBOST, MD
- Recruiting
CHU Dijon Bourgogne - Hôpital François Mitterrand
Dijon
Vanessa LEGUY-SEGUIN, MD, 03 80 29 34 32 ext. +33, alexandre.guilhem@chu-dijon.fr
Laurence OLIVIER-FAIVRE, MD-PhD
- Recruiting
Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille
Lille, 59037
Pascal DELSART, MD, 03 20 44 43 65 ext. +33, Pascal.DELSART@CHRU-LILLE.FR
Pascal DELSART, MD
- Recruiting
Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez
Lille, 59037
Hélène MAILLARD, MD, 03 20 44 50 48 ext. +33, Helene.MAILLARD@CHRU-LILLE.FR
Marc LAMBERT, MD
- Recruiting
CHU de Marseille - Hôpital de la Timone
Marseille, 13385
Baptiste ANDRE, MD, 04 91 38 89 90 ext. +33, baptiste.andre@aphm.fr
Anthony REYRE, MD-PhD
- Recruiting
Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier
Montpellier, 34295
Sophie RIVIERE, MD, 04 67 33 73 32 ext. +33, s-riviere@chu-montpellier.fr
Sophie RIVIERE, MD
- Withdrawn
Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien
Nancy, 54035
- Recruiting
Service de Médecine Interne-Médecine Vasculaire, CHU de Nantes - Hôtel Dieu
Nantes, 44093
Olivier ESPITIA, MD, 02 40 08 33 55 ext. +33, olivier.espitia@chu-nantes.fr
Olivier ESPITIA, MD
- Recruiting
Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2
Nice, 06001
Jacques SEDAT, MD, 04.92.03.38.07 ext. +33, nri@chu-nice.fr
Jacques SEDAT, MD
- Recruiting
Service de dermatologie, CHU de Nice - Hôpital l'Archet 2
Nice, 06202
Christine CHIAVERINI, MD, 04.92.03.92.11 ext. +33, chiaverini.c@chu-nice.fr
Christine CHIAVERINI, MD
- Recruiting
Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière)
Paris, 75010
Annouk BISDORFF-BRESSON, MD, 01 49 95 83 59 ext. +33, annouk.bisdorff@aphp.fr
Annouk BISDORFF-BRESSON, MD
- Recruiting
Service de Lymphologie - Hôpital Cognacq-Jay - Paris
Paris, 75015
Stéphane VIGNES, MD, 01 45 30 81 83 ext. +33, stephane.vignes@cognacq-jay.fr
Stéphane VIGNES, MD
- Recruiting
Service de Cardiologie - Hôpital Bichat, AP-HP
Paris, 75018
Guillaume JONDEAU, MD-PhD, 01 40 25 68 11 ext. +33, guillaume.jondeau@aphp.fr
Guillaume JONDEAU, MD-PHd
- Recruiting
Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild
Paris, 75019
William BOISSEAU, MD, 01 48 03 68 31 ext. +33, wboisseau@for.paris
William BOISSEAU, MD
- Recruiting
Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP
Paris
Michel DJIBRE, MD, 01 56 01 76 29 ext. +33, michel.djibre@aphp.fr
Michel DJIBRE, MD
- Recruiting
Service de Génétique CHU de Poitiers
Poitiers, 86021
Xavier LE GUILLOU-HORN, MD, 05 49 44 39 22 ext. +33, xavier.le-guillou@chu-poitiers.fr
Xavier LE GUILLOU-HORN, MD
- Recruiting
Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
Mallorie KERJOUAN, MD, 02 99 28 37 38 ext. +33, mallorie.kerjouan@chu-rennes.fr
Mallorie KERJOUAN, MD
- Recruiting
Unité de Génétique médicale, CHU de Rennes, Hôpital Sud
Rennes, 35203
Sylvie ODENT, MD-PhD, 02 99 26 67 44 ext. +33, sylvie.odent@chu-rennes.fr
Sylvie ODENT, MD-PhD
- Withdrawn
Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle
Rouen, 76000
- Recruiting
Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord
Saint-Etienne, 42055
Claire LE HELLO, MD-PhD, 04.77.82.94.24 ext. +33, claire.lehello@chu-st-etienne.fr
Claire LE HELLO, MD-PhD
- Recruiting
Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC
Saint-Herblain, 44800
Laurianne LE GLOAN, MD, 02 40 08 33 33 ext. +33, laurianne.legloan@chu-nantes.fr
Laurianne LE GLOAN, MD
- Recruiting
Service Maladies vasculaires - HTA - NHC Pôle Médico-chirurgicale cardio-vasculaire, CHU de Strasbourg - Hôpital Civil
Strasbourg, 67091
Dominique STEPHAN, MD-PhD, 03 69 55 05 36 ext. +33, dominique.stephan@chru-strasbourg.fr
Dominique STEPHAN, MD-PhD
- Recruiting
CHU de Strasbourg, Hôpital de Hautepierre
Strasbourg, 67200
Murielle RONDEAU-LUTZ, MD, 03 88 12 81 25 ext. +33, murielle.rondeau-lutz@chru-strasbourg.fr
Murielle RONDEAU-LUTZ, MD
- Recruiting
Service de Neuroradiologie Interventionnelle - Hôpital Foch
Suresnes, 92151
Georges RODESCH, MD, 01 46 25 26 60 ext. +33, g.rodesch@hopital-foch.org
Georges RODESCH, MD
- Recruiting
Service de Cardiologie _ Hôpital des Enfants (Purpan)
Toulouse, 31026
Yves DULAC, MD, 05 34 55 85 96 ext. +33, dulac.y@chu-toulouse.fr
Yves DULAC, MD
- Recruiting
Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL
Toulouse, 31059
Laurent ALRIC, MD-PhD, 05 61 32 35 95 ext. +33, alric.l@chu-toulouse.fr
Alessandra BURA-RIVIERE, Pr, 05 61 32 24 38 ext. +33, bura-riviere.a@chu-toulouse.fr
- Recruiting
Service Pneumologie, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de TOURS
Tours, 37044
Pascal MAGRO, MD, 02 47 47 37 87 ext. +33, magro@med.univ-tours.fr
Pascal MAGRO, MD
- Withdrawn
CHU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study
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.
- Conditions
- Vascular Anomaly, Osler Rendu Disease, Marfan Syndrome or Related, Lymphedema Primary, Arteriovenous Malformations, Cerebrospinal; Disorder
- Being tested
- Questionnaire
- Medical subject headings
- Vascular Malformations, Telangiectasia, Hereditary Hemorrhagic, Marfan Syndrome, Lymphedema, Arteriovenous Malformations, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Interview of women with a rare vascular disease through a phone questionnaire about severe and specific obstetrical complications during and after pregnancy.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 3 months up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start6 Feb 2020
- Primary completionFeb 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AnomalyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie DUPUIS-GIROD, MD, Principal investigator, Service de Génétique - Hôpital Femme-Mère-Enfant - HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194619
- Sponsor's protocol ID
- 69HCL19_0380
- Acronym
- COGRare5
- Status last verified
- Mar 2026
- First submitted
- 9 Dec 2019
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No