French Registry for Monitoring Pregnancies for Multiple Sclerosis

Last updated: March 7, 2025
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Multiple Sclerosis

Neurologic Disorders

Treatment

No intervention

Clinical Study ID

NCT03900221
69HCL18_0631
2018-A02552-53
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • All groups of patients eligible to participate to the Observatoire Français de laSclérose en Plaque (OFSEP), including :

  • Definite Multiple sclerosis (MS) according to McDonald criteria

  • Whatever the clinical course (single attack MS, relapsing-remitting MS, secondaryprogressive 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 informedconsent is obtained from the parents)

  • Ongoing pregnancy: there will be no limit in the gestational age at inclusion. Womencan be included at any time before delivery, but the gestational age at inclusionwill be recorded and introduced in the analyses whenever pertinent. However,neurologists and patients will be encouraged to start the study as soon as pregnancyis diagnosed.

  • Able to give informed consent

  • Able to read and/or understand French

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
August 12, 2019
Estimated Completion Date:
August 12, 2036

Study 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 Français de la Sclérose en Plaque (OFSEP) (definite MS, radiologically isolated syndromes, clinically isolated syndromes, neuromyelitis optica (NMO) and NMO spectrum disorders), with no age limit and an ongoing pregnancy. Women will be followed during pregnancy and in the year after and their children until 6 years of age.

STATISTICAL ANALYSIS To be determined for each specific question. EXPECTED RESULTS Interactions between pregnancy and MS course have been well characterized before the therapeutic era. Neurologists and patients are lacking information to weigh benefits and risks of DMDs used immediately before or during pregnancy, including short and long-term risks to the mother and to the child, but also after delivery. This study should help provide better answers to those questions as well as to still controversial questions about locoregional analgesia and breastfeeding. By following these patients within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, the investigator will also have access to a comprehensive description of MS before pregnancy but also in the long term.

Connect with a study center

  • Chu D'Amiens

    Amiens, 80054
    France

    Active - Recruiting

  • Centre Hospitalier Annecy Genevois

    Annecy, 74000
    France

    Active - Recruiting

  • Centre Hospitalier d'Avignon

    Avignon, 84000
    France

    Active - Recruiting

  • Hopital Jean Minjoz

    Besançon, 25030
    France

    Active - Recruiting

  • Hopital Pellegrin

    Bordeaux, 33076
    France

    Active - Recruiting

  • Hôpital Neurologique Pierre Wertheimer

    Bron, 69677
    France

    Active - Recruiting

  • Hopital Cote de Nacre

    Caen, 14033
    France

    Active - Recruiting

  • Centre hospitalier Métropole Savoie

    Chambéry, 73000
    France

    Active - Recruiting

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • Hopital Henri Mondor

    Créteil, 94010
    France

    Active - Recruiting

  • Hopital Du Bocage

    Dijon, 21079
    France

    Active - Recruiting

  • Ch Epinal

    Epinal, 88000
    France

    Active - Recruiting

  • Hôpital Raymond Poincaré

    Garches, 92380
    France

    Active - Recruiting

  • Chu de Grenoble

    Grenoble, 38043
    France

    Active - Recruiting

  • Centre Hospitalier de Versailles Hôpital Andre Mignot

    Le Chesnay, 78157
    France

    Active - Recruiting

  • Chru de Lille

    Lille, 59037
    France

    Active - Recruiting

  • Hôpital St Vincent De Paul

    Lille, 59020
    France

    Active - Recruiting

  • Hopital Dupuytren

    Limoges, 87042
    France

    Active - Recruiting

  • Cabinet médical Dr C. CORNUT-CHAUVINC

    Lyon, 69008
    France

    Active - Recruiting

  • Cabinet médical Dr Philippe NEUSCHWANDER

    Lyon, 69006
    France

    Active - Recruiting

  • Centre Hospitalier Saint Joseph Saint Luc

    Lyon, 69007
    France

    Active - Recruiting

  • Hopital Timone Adultes

    Marseille, 13385
    France

    Active - Recruiting

  • Hopital Gui de Chauliac

    Montpellier, 34295
    France

    Active - Recruiting

  • Cabinet médical Dr L. GUILLOTON

    Mornant, 69440
    France

    Active - Recruiting

  • Hôpital Central

    Nancy, 54035
    France

    Active - Recruiting

  • Hopital Pasteur

    Nice, 06001
    France

    Active - Recruiting

  • Hopital Caremeau

    Nîmes, 30029
    France

    Active - Recruiting

  • Fondation Rotschild

    Paris, 75019
    France

    Active - Recruiting

  • Hopital Pitie Salpetriere

    Paris, 75651
    France

    Active - Recruiting

  • Hopital Saint Antoine

    Paris, 75570
    France

    Site Not Available

  • Hôpital Paris Saint Joseph

    Paris, 75014
    France

    Active - Recruiting

  • Hôpital national des Quinze-Vingt.

    Paris, 75571
    France

    Active - Recruiting

  • Chi Poissy Saint Germain En Laye

    Poissy, 78303
    France

    Active - Recruiting

  • Chr La Miletrie

    Poitiers, 86021
    France

    Active - Recruiting

  • Hopital Rene Dubos

    Pontoise, 95300
    France

    Active - Recruiting

  • Hopital de La Maison Blanche

    Reims, 51092
    France

    Site Not Available

  • Hopital Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

  • Hôpital Charles-Nicolle

    Rouen, 76000
    France

    Active - Recruiting

  • Centre Hospitalier de Saint-Denis

    Saint-Denis, 93200
    France

    Active - Recruiting

  • Hopital G. Et R. Laennec

    Saint-Herblain, 44800
    France

    Active - Recruiting

  • Centre Hospitalier Mémorial

    Saint-Lô, 50009
    France

    Active - Recruiting

  • Hopital Nord

    Saint-Priest-en-Jarez, 42277
    France

    Active - Recruiting

  • Hopital Hautepierre

    Strasbourg, 67098
    France

    Active - Recruiting

  • Hôpital Foch

    Suresnes, 92151
    France

    Active - Recruiting

  • Hopital Purpan

    Toulouse, 31059
    France

    Active - Recruiting

  • Chru de Tours Hopital Bretonneau

    Tours, 37044
    France

    Active - Recruiting

  • Médipôle Lyon Villeurbanne

    Villeurbanne, 69100
    France

    Active - Recruiting

  • Hopital P. Zobda-Quitman

    Fort-de-France, 97200
    Martinique

    Active - Recruiting

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