French Registry for Monitoring Pregnancies for Multiple Sclerosis
French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort
Hospices Civils de Lyon
1,500 participants
Aug 12, 2019
OBSERVATIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria1
- None
Interventions
No intervention
Locations(48)
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NCT03900221