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French Registry for Monitoring Pregnancies for Multiple Sclerosis

Recruitingn/aAges any - anyAllHospices Civils de Lyon
NCT03900221 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-rela

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📋 Eligibility rules (as published)
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
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What it tests

  • No intervention
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Where

48 sites
Chu D'Amiens
Amiens, France
Centre Hospitalier Annecy Genevois
Annecy, France
Centre Hospitalier d'Avignon
Avignon, France
Hopital Jean Minjoz
Besançon, France
Hopital Pellegrin
Bordeaux, France
Hôpital de Brive
Brive-la-Gaillarde, France
Hôpital Neurologique Pierre Wertheimer
Bron, France
Hopital Cote de Nacre
Caen, France

…and 40 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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