NCT04194619 Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study
| NCT ID | NCT04194619 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Vascular Anomaly |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2020-02-06 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2020-02-06 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Sophie DUPUIS-GIROD, MD
PRINCIPAL INVESTIGATOR
Service de Génétique - Hôpital Femme-Mère-Enfant - HCL
Frequently Asked Questions
Who can join the NCT04194619 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Vascular Anomaly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04194619 currently recruiting?
Yes, NCT04194619 is actively recruiting participants. Contact the research team at sophie.dupuis-girod@chu-lyon.fr for enrollment information.
Where is the NCT04194619 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, Boulogne-Billancourt, France, Bron, France and 11 additional locations.
Who is sponsoring the NCT04194619 clinical trial?
NCT04194619 is sponsored by Hospices Civils de Lyon. The principal investigator is Sophie DUPUIS-GIROD, MD at Service de Génétique - Hôpital Femme-Mère-Enfant - HCL. The trial plans to enroll 400 participants.