ClinicalTrials.gg
RecruitingNCT04194619COGRare5Updated Sep 28, 2026

Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study

An observational study in Vascular Anomaly, Osler Rendu Disease and Marfan Syndrome or Related, sponsored by Hospices Civils de Lyon. Recruiting at 37 sites in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Hospices Civils de Lyon · Observational

From the registry’s dates

  • Started Feb 2020; still recruiting 6 years 9 months later.
Updated Sep 28, 2026Site recruiting status changed1 site addedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Vascular Anomaly
  • Osler Rendu Disease
  • Marfan Syndrome or Related
  • Lymphedema Primary
  • Arteriovenous Malformations
  • Cerebrospinal; Disorder
03

In context

Vascular Malformations

79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 27 observational studies indexed under Vascular Malformations.

Browse Vascular Malformations studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Any person not fulfilling the inclusion criteria or refusing to take part in the study.
  • Major under legal protection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Interventions

  • OtherQuestionnaire

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

06

What researchers measure

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.

    Time frame: Every 3 months up to 21 months

07

Study locations

31 of 37 sites recruiting
  • Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers
    Angers, 49933, France
    Recruiting
  • Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux
    Bordeaux, 33075, France
    Withdrawn

    Not enrolling at this site — choose another above.

  • CHU de Bordeaux - Groupe Hospitalier Pellegrin Service de Radiologie et de neuro-imagerie
    Bordeaux, 33076, France
    Not yet recruiting
  • Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré
    Boulogne-Billancourt, 92104, France
    Recruiting
    • Sandra BLIVET, MD · ContactSandra.blivet@aphp.fr · 01 49 09 44 32
    • Sandra BLIVET, MD · Principal investigator
  • Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon
    Bron, 69677, France
    Recruiting
  • Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL
    Bron, 69677, France
    Withdrawn

    Not enrolling at this site — choose another above.

  • Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL
    Bron, 69677, France
    Recruiting
  • Service de Génétique, Hôpital Femme-Mère-Enfant
    Bron, 69677, France
    Recruiting
  • Service de Médecine Vasculaire - Hôpital de la Côte de Nacre
    Caen, 14033, France
    Recruiting
    • Laurent CHAUSSAVOINE, MD · Contactchaussavoine-l@chu-caen.fr · 02 31 06 53 27
    • Damien LANEELLE, MD · Sub investigator
    • Fabien LABOMBARDA, MD · Sub investigator
    • Laurent CHAUSSAVOINE, MD · Principal investigator
  • Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing
    Clermont-Ferrand, 63000, France
    Recruiting
  • CHU Dijon Bourgogne - Hôpital François Mitterrand
    Dijon, France
    Recruiting
    • Vanessa LEGUY-SEGUIN, MD · Contactalexandre.guilhem@chu-dijon.fr · 03 80 29 34 32
    • Laurence OLIVIER-FAIVRE, MD-PhD · Sub investigator
    • Vanessa LEGUY-SEGUIN, MD · Principal investigator
  • Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille
    Lille, 59037, France
    Recruiting
  • Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez
    Lille, 59037, France
    Recruiting
    • Hélène MAILLARD, MD · ContactHelene.MAILLARD@CHRU-LILLE.FR · 03 20 44 50 48
    • Marc LAMBERT, MD · Sub investigator
    • Hélène MAILLARD, MD · Principal investigator
  • CHU de Marseille - Hôpital de la Timone
    Marseille, 13385, France
    Recruiting
    • Baptiste ANDRE, MD · Contactbaptiste.andre@aphm.fr · 04 91 38 89 90
    • Anthony REYRE, MD-PhD · Sub investigator
    • Laurence BAL-THEOLEYRE, MD · Sub investigator
    • Baptiste ANDRE, MD · Principal investigator
  • Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier
    Montpellier, 34295, France
    Recruiting
    • Sophie RIVIERE, MD · Contacts-riviere@chu-montpellier.fr · 04 67 33 73 32
    • Sophie RIVIERE, MD · Principal investigator
    • Isabelle QUERE, PD-PhD · Sub investigator
  • Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien
    Nancy, 54035, France
    Withdrawn

    Not enrolling at this site — choose another above.

  • Service de Médecine Interne-Médecine Vasculaire, CHU de Nantes - Hôtel Dieu
    Nantes, 44093, France
    Recruiting
  • Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2
    Nice, 06001, France
    Recruiting
    • Jacques SEDAT, MD · Contactnri@chu-nice.fr · 04.92.03.38.07
    • Jacques SEDAT, MD · Principal investigator
  • Service de dermatologie, CHU de Nice - Hôpital l'Archet 2
    Nice, 06202, France
    Recruiting
    • Christine CHIAVERINI, MD · Contactchiaverini.c@chu-nice.fr · 04.92.03.92.11
    • Christine CHIAVERINI, MD · Principal investigator
  • Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière)
    Paris, 75010, France
    Recruiting
    • Annouk BISDORFF-BRESSON, MD · Contactannouk.bisdorff@aphp.fr · 01 49 95 83 59
    • Annouk BISDORFF-BRESSON, MD · Principal investigator
  • Service de Lymphologie - Hôpital Cognacq-Jay - Paris
    Paris, 75015, France
    Recruiting
  • Service de Cardiologie - Hôpital Bichat, AP-HP
    Paris, 75018, France
    Recruiting
    • Guillaume JONDEAU, MD-PhD · Contactguillaume.jondeau@aphp.fr · 01 40 25 68 11
    • Guillaume JONDEAU, MD-PHd · Principal investigator
  • Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild
    Paris, 75019, France
    Recruiting
    • William BOISSEAU, MD · Contactwboisseau@for.paris · 01 48 03 68 31
    • William BOISSEAU, MD · Principal investigator
  • Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP
    Paris, France
    Recruiting
    • Michel DJIBRE, MD · Contactmichel.djibre@aphp.fr · 01 56 01 76 29
    • Michel DJIBRE, MD · Principal investigator
  • Service de Génétique CHU de Poitiers
    Poitiers, 86021, France
    Recruiting
  • Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou
    Rennes, 35033, France
    Recruiting
  • Unité de Génétique médicale, CHU de Rennes, Hôpital Sud
    Rennes, 35203, France
    Recruiting
  • Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle
    Rouen, 76000, France
    Withdrawn

    Not enrolling at this site — choose another above.

  • Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord
    Saint-Etienne, 42055, France
    Recruiting
  • Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC
    Saint-Herblain, 44800, France
    Recruiting
  • Service Maladies vasculaires - HTA - NHC Pôle Médico-chirurgicale cardio-vasculaire, CHU de Strasbourg - Hôpital Civil
    Strasbourg, 67091, France
    Recruiting
  • CHU de Strasbourg, Hôpital de Hautepierre
    Strasbourg, 67200, France
    Recruiting
  • Service de Neuroradiologie Interventionnelle - Hôpital Foch
    Suresnes, 92151, France
    Recruiting
  • Service de Cardiologie _ Hôpital des Enfants (Purpan)
    Toulouse, 31026, France
    Recruiting
  • Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL
    Toulouse, 31059, France
    Recruiting
    • Laurent ALRIC, MD-PhD · Contactalric.l@chu-toulouse.fr · 05 61 32 35 95
    • Alessandra BURA-RIVIERE, Pr · Contactbura-riviere.a@chu-toulouse.fr · 05 61 32 24 38
    • Laurent ALRIC, MD-PhD · Principal investigator
    • Alessandra BURA-RIVIERE, MD-PhD · Sub investigator
  • Service Pneumologie, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de TOURS
    Tours, 37044, France
    Recruiting
  • CHU de Nancy - Hôpitaux de Brabois
    Vandœuvre-lès-Nancy, 54511, France
    Withdrawn

    Not enrolling at this site — choose another above.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2020 (actual). Primary completion is estimated for Feb 2027, 84 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2019
First posted
Dec 11, 2019
StartActual
Feb 6, 2020
Primary completionEst.
Feb 2027
CompletionEst.
Nov 2028
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added. Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien is now Withdrawn
Show site
  • CHU de Bordeaux - Groupe Hospitalier Pellegrin Service de Radiologie et de neuro-imagerie · Bordeaux, France
Sep 28, 2026
Site contacts
Changed at 3 sites. See the sites
Show 3 sites
  • Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien · Nancy, FranceContact removed s•••@chru-nancy.fr · •••1773Contact removed (no phone or email listed)
  • Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild · Paris, FranceContact s•••@for.paris · •••6565→w•••@for.paris · •••6831Contact person changed (no phone or email listed)
  • Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP · Paris, FranceContact a•••@aphp.fr · •••7629→m•••@aphp.fr · •••7629Contact person changed (no phone or email listed)
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    1 site added. Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien is now Withdrawn
    Show site
    • CHU de Bordeaux - Groupe Hospitalier Pellegrin Service de Radiologie et de neuro-imagerie · Bordeaux, France
    Site contacts Changed at 3 sites. See the sites
    Show 3 sites
    • Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien · Nancy, FranceContact removed s•••@chru-nancy.fr · •••1773Contact removed (no phone or email listed)
    • Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild · Paris, FranceContact s•••@for.paris · •••6565→w•••@for.paris · •••6831Contact person changed (no phone or email listed)
    • Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP · Paris, FranceContact a•••@aphp.fr · •••7629→m•••@aphp.fr · •••7629Contact person changed (no phone or email listed)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04194619
Responsible party
Sponsor
First posted
Dec 11, 2019
Start date
Feb 6, 2020
Primary completion
Feb 2027 (estimated)
Completion
Nov 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Sophie DUPUIS-GIROD, MD
Contact
sophie.dupuis-girod@chu-lyon.fr
04 27 85 65 25 ext. +33
Amal AYADI ROBERT
Contact
amal.ayadi@chu-lyon.fr
04 27 85 66 03 ext. +33
Sophie DUPUIS-GIROD, MD
principal investigator · Service de Génétique - Hôpital Femme-Mère-Enfant - HCL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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