Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study

N/ARecruitingNCT04194619

Hospices Civils de Lyon400 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

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

Interventions

QuestionnaireOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (36)

Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers

Angers, France

RECRUITING

Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux

Bordeaux, France

RECRUITING

Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré

Boulogne-Billancourt, France

RECRUITING

Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon

Outcomes

Primary Outcomes

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

Central Contacts

Sophie DUPUIS-GIROD, MD

CONTACT

04 27 85 65 25 sophie.dupuis-girod@chu-lyon.fr

Amal AYADI ROBERT

CONTACT

04 27 85 66 03 amal.ayadi@chu-lyon.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL

Bron, France

RECRUITING

Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL

Bron, France

RECRUITING

Service de Génétique, Hôpital Femme-Mère-Enfant

Bron, France

RECRUITING

Service de Médecine Vasculaire - Hôpital de la Côte de Nacre

Caen, France

RECRUITING

Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing

Clermont-Ferrand, France

RECRUITING

CHU Dijon Bourgogne - Hôpital François Mitterrand

Dijon, France

RECRUITING

...and 26 more locations