Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study (COGRare5)

December 9, 2019 updated by: Hospices Civils de Lyon

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, 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49933
        • Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers
        • Contact:
        • Contact:
      • Bordeaux, France, 33075
        • Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux
        • Contact:
        • Contact:
      • Boulogne-Billancourt, France, 92104
        • Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré
        • Contact:
      • Bron, France, 69677
        • Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon
        • Contact:
        • Contact:
      • Bron, France, 69677
        • Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL
        • Contact:
      • Bron, France, 69677
        • Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL
        • Contact:
      • Caen, France, 14033
        • Service de Médecine Vasculaire - Hôpital de la Côte de Nacre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Damien LANEELLE, Dr
      • Clermont-Ferrand, France, 63000
        • Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing
        • Contact:
      • Dijon, France
      • Lille, France, 59037
        • Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille
        • Contact:
      • Lille, France, 59037
      • Marseille, France, 13385
        • CHU de Marseille - Hôpital de la Timone
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Nadine GIRARD, Pr
      • Montpellier, France, 34295
        • Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier
        • Contact:
      • Nancy, France, 54035
        • Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien
        • Contact:
      • Nice, France, 06001
        • Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2
        • Contact:
          • Jacques SEDAT, Dr
          • Phone Number: +33 04.92.03.38.07
          • Email: nri@chu-nice.fr
      • Paris, France, 75010
        • Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière)
        • Contact:
      • Paris, France, 75015
        • Service de Lymphologie - Hôpital Cognacq-Jay - Paris
      • Paris, France, 75018
        • Service de Cardiologie - Hôpital Bichat, AP-HP
        • Contact:
      • Paris, France, 75019
        • Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild
        • Contact:
      • Paris, France
        • Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP
        • Contact:
      • Poitiers, France, 86021
      • Rennes, France, 35033
        • Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou
        • Contact:
      • Rennes, France, 35203
        • Unité de Génétique médicale, CHU de Rennes, Hôpital Sud
        • Contact:
      • Rouen, France, 76000
        • Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle
      • Saint-Herblain, France, 44800
        • Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC
        • Contact:
      • Saint-Étienne, France, 42055
        • Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord
        • Contact:
      • Strasbourg, France, 67098
      • Suresnes, France, 92151
        • Service de Neuroradiologie Interventionnelle - Hôpital Foch
        • Contact:
      • Toulouse, France, 31026
        • Service de Cardiologie _ Hôpital des Enfants (Purpan)
        • Contact:
      • Toulouse, France, 31059
        • Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL
        • Contact:
        • Contact:
      • Tours, France
        • Service Pneumologie + Service de Dermatologie _ Hôpital Bretonneau Centre Hospitalier Régional Universitaire de TOURS
        • Contact:
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54511
        • CHU de Nancy - Hopitaux de Brabois
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Denis WAHL, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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, primary lower limb lymphedema, superficial arteriovenous malformations or even cerebro-spinal arteriovenous malformations.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of obstetrical complications among patients with rare vascular anomalies.
Time Frame: 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.
Maximum 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2025

Study Completion (ANTICIPATED)

September 1, 2026

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (ACTUAL)

December 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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