Status:
RECRUITING
French Registry for Monitoring Pregnancies for Multiple Sclerosis
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Sclerosis, Multiple
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
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, counsel...
Detailed Description
METHODOLOGY Prospective, observational, multicentric and national epidemiological study, within the scope of the OFSEP, including all groups of patients eligible to participate in the Observatoire Fra...
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
Key Trial Info
Start Date :
August 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 12 2036
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03900221
Start Date
August 12 2019
End Date
August 12 2036
Last Update
January 5 2026
Active Locations (48)
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1
Chu D'Amiens
Amiens, France, 80054
2
Centre Hospitalier Annecy Genevois
Annecy, France, 74000
3
Centre Hospitalier d'Avignon
Avignon, France, 84000
4
Hopital Jean Minjoz
Besançon, France, 25030