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NCT03900221Recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Jan 2026

Brief summary (registry, in English)

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…)

Status (registry)
Recruiting
Study type
Observational
Enrollment
1500 (estimated)
First submitted
8 Mar 2019
Start date
12 Aug 2019
Primary completion date
12 Aug 2036
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT03900221

What you commit to

  • Study type: Observational
  • Planned participants: 1500
  • From 12 Aug 2019 to the primary completion date, 12 Aug 2036
  • 48 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • None

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU D'amiens
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AmiensFranceRecruiting
Centre Hospitalier Annecy Genevois
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AnnecyFranceRecruiting
Centre Hospitalier d'Avignon
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AvignonFranceRecruiting
Hopital Jean Minjoz
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BesançonFranceRecruiting
Hopital Pellegrin
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BordeauxFranceRecruiting
Hôpital de Brive
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Brive-la-GaillardeFranceRecruiting
Hôpital Neurologique Pierre Wertheimer
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BronFranceRecruiting
Hôpital Côte De Nacre
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CaenFranceRecruiting
Centre Hospitalier Métropole Savoie
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ChambéryFranceRecruiting
Hopital Gabriel Montpied
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Clermont-FerrandFranceRecruiting
Hopital Henri Mondor
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CréteilFranceRecruiting
Hopital Du Bocage
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DijonFranceRecruiting
Ch Epinal
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ÉpinalFranceRecruiting
Hôpital Raymond-Poincaré
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GarchesFranceRecruiting
Centre hospitalier Joséphine Baker Gonesse
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GonesseFranceRecruiting
CHU de Grenoble
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GrenobleFranceRecruiting
Centre Hospitalier de Versailles Hôpital Andre Mignot
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Le ChesnayFranceRecruiting
CHRU de Lille
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LilleFranceRecruiting
Hôpital St Vincent de Paul
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LilleFranceRecruiting
Hopital Dupuytren
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LimogesFranceRecruiting
Cabinet médical Dr C. CORNUT-CHAUVINC
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LyonFranceRecruiting
Centre Hospitalier Saint Joseph Saint Luc
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LyonFranceRecruiting
Cabinet médical Dr Philippe NEUSCHWANDER
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LyonFranceRecruiting
Hopital Timone Adultes
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MarseilleFranceRecruiting
Hôpital Gui de Chauliac
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MontpellierFranceRecruiting
Cabinet médical Dr L. GUILLOTON
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MornantFranceRecruiting
Hôpital Central,
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NancyFranceRecruiting
Hopital PASTEUR
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NiceFranceRecruiting
Hopital Caremeau
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NîmesFranceRecruiting
Hopital Pitie-Salpetriere
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ParisFranceRecruiting
Hôpital national des Quinze-Vingt.
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ParisFranceRecruiting
Fondation Rotschild
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ParisFranceRecruiting
Hôpital Paris Saint Joseph
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ParisFranceRecruiting
CHI Poissy-Saint-Germain en Laye
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PoissyFranceRecruiting
Chr La Miletrie
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PoitiersFranceRecruiting
Hopital Rene Dubos
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PontoiseFranceRecruiting
Hôpital Pontchaillou
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RennesFranceRecruiting
Hôpital Charles Nicolle
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RouenFranceRecruiting
Centre Hospitalier de Saint-Denis
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Saint-DenisFranceRecruiting
Hopital G. Et R. Laennec
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Saint-HerblainFranceRecruiting
Centre Hospitalier Mémorial
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Saint-LôFranceRecruiting
Hopital Nord
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Saint-Priest-en-JarezFranceRecruiting
Hopital Hautepierre
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StrasbourgFranceRecruiting
Hopital Foch
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SuresnesFranceRecruiting
Hopital Purpan
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ToulouseFranceRecruiting
CHRU de Tours- Hopital Bretonneau
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ToursFranceRecruiting
Médipôle Lyon-Villeurbanne
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VilleurbanneFranceRecruiting
Hopital P. Zobda-Quitman
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Fort-de-FranceMartiniqueRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.