Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire.
- Who it may be relevant to
- Registry conditions: Vascular Anomaly, Osler Rendu Disease, Marfan Syndrome or Related, Lymphedema Primary. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study
Overview
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.
Interventions
- Other Questionnaire
Interview of women with a rare vascular disease through a phone questionnaire about severe and specific obstetrical complications during and after pregnancy.
Primary outcome measures
- Occurrence of obstetrical complications among patients with rare vascular anomalies. [Time frame: Every 3 months up to 21 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 36 centers
- Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochiru — Angers
- Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôp — Bordeaux
- Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré — Boulogne-Billancourt
- Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital — Bron
- Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. — Bron
- Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - — Bron
- Service de Génétique, Hôpital Femme-Mère-Enfant — Bron
- Service de Médecine Vasculaire - Hôpital de la Côte de Nacre — Caen
- … and 28 more centers
Identifiers
NCT: NCT04194619 · 69HCL19_0380