French Registry for Monitoring Pregnancies for Multiple Sclerosis
Recruiting now
Conditions studied: Sclerosis, Multiple, Neuromyelitis Optica Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders, Pregnancy Abnormal
In brief
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…)
Key facts
- Study ID
- NCT03900221
- Run by
- Hospices Civils de Lyon
- People needed
- 1500
- Starts
- 2019-08-12
- Expected to finish
- 2036-08-12
- Last updated by the study team
- 2026-01-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- None
Where it is running
- Chu D'Amiens — Amiens, France (enrolling)
- Centre Hospitalier Annecy Genevois — Annecy, France (enrolling)
- Centre Hospitalier d'Avignon — Avignon, France (enrolling)
- Hopital Jean Minjoz — Besançon, France (enrolling)
- Hopital Pellegrin — Bordeaux, France (enrolling)
- Hôpital de Brive — Brive-la-Gaillarde, France (enrolling)
- Hôpital Neurologique Pierre Wertheimer — Bron, France (enrolling)
- Hopital Cote de Nacre — Caen, France (enrolling)
- Centre hospitalier Métropole Savoie — Chambéry, France (enrolling)
- Hopital Gabriel Montpied — Clermont-Ferrand, France (enrolling)
- Hopital Henri Mondor — Créteil, France (enrolling)
- Hopital Du Bocage — Dijon, France (enrolling)
- Ch Epinal — Épinal, France (enrolling)
- Hôpital Raymond Poincaré — Garches, France (enrolling)
- Centre hospitalier Joséphine Baker Gonesse — Gonesse, France (enrolling)
- Chu de Grenoble — Grenoble, France (enrolling)
- Centre Hospitalier de Versailles Hôpital Andre Mignot — Le Chesnay, France (enrolling)
- Hôpital St Vincent De Paul — Lille, France (enrolling)
- Chru de Lille — Lille, France (enrolling)
- Hopital Dupuytren — Limoges, France (enrolling)
- Cabinet médical Dr Philippe NEUSCHWANDER — Lyon, France (enrolling)
- Centre Hospitalier Saint Joseph Saint Luc — Lyon, France (enrolling)
- Cabinet médical Dr C. CORNUT-CHAUVINC — Lyon, France (enrolling)
- Hopital Timone Adultes — Marseille, France (enrolling)
- Hopital Gui de Chauliac — Montpellier, France (enrolling)
Full record on ClinicalTrials.gov
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