NCT03900221 French Registry for Monitoring Pregnancies for Multiple Sclerosis
| NCT ID | NCT03900221 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Sclerosis, Multiple |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2019-08-12 |
| Primary Completion | 2036-08-12 |
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 1,500 participants in total. It began in 2019-08-12 with a primary completion date of 2036-08-12.
⚠ 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
The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia. To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)
Eligibility Criteria
Inclusion Criteria: * All groups of patients eligible to participate to the Observatoire Français de la Sclérose en Plaque (OFSEP), including : * Definite Multiple sclerosis (MS) according to McDonald criteria * Whatever the clinical course (single attack MS, relapsing-remitting MS, secondary progressive MS, primary progressive MS) * Radiologically Isolated Syndromes (RIS) (will be validated by the RIS expert group) * Clinically Isolated Syndromes (CIS) * Neuromyelitis optica (NMO) and NMO spectrum disorders (will be validated by the "Neuro-optico-myélite aiguë de Devic et des syndromes neurologiques apparentés" (NOMADMUS) expert group) * No age limit (patients under the age of 18 might be included, provided informed consent is obtained from the parents) * Ongoing pregnancy: there will be no limit in the gestational age at inclusion. Women can be included at any time before delivery, but the gestational age at inclusion will be recorded and introduced in the analyses whenever pertinent. However, neurologists and patients will be encouraged to start the study as soon as pregnancy is diagnosed. * Able to give informed consent * Able to read and/or understand French Exclusion Criteria: * None
Contact & Investigator
Sandra VUKUSIC, Prof.
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT03900221 clinical trial?
This trial is open to participants of all sexes, studying Sclerosis, Multiple. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03900221 currently recruiting?
Yes, NCT03900221 is actively recruiting participants. Contact the research team at sandra.vukusic@chu-lyon.fr for enrollment information.
Where is the NCT03900221 trial being conducted?
This trial is being conducted at Amiens, France, Annecy, France, Avignon, France, Besançon, France and 11 additional locations.
Who is sponsoring the NCT03900221 clinical trial?
NCT03900221 is sponsored by Hospices Civils de Lyon. The principal investigator is Sandra VUKUSIC, Prof. at Hospices Civils de Lyon. The trial plans to enroll 1,500 participants.