French Registry for Monitoring Pregnancies for Multiple Sclerosis
NCT ID: NCT03900221
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2019-08-12
2036-08-12
Brief Summary
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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…)
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant women with multiple sclerosis or related neurological
Children born to women with multiple sclerosis or related neurological syndromes.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Sandra VUKUSIC, Prof.
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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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
Centre hospitalier Métropole Savoie
Chambéry, , France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
Hopital Henri Mondor
Créteil, , France
Hopital Du Bocage
Dijon, , France
Ch Epinal
Épinal, , France
Hôpital Raymond Poincaré
Garches, , France
Centre hospitalier Joséphine Baker Gonesse
Gonesse, , France
Chu de Grenoble
Grenoble, , France
Centre Hospitalier de Versailles Hôpital Andre Mignot
Le Chesnay, , France
Hôpital St Vincent De Paul
Lille, , France
Chru de Lille
Lille, , France
Hopital Dupuytren
Limoges, , France
Cabinet médical Dr Philippe NEUSCHWANDER
Lyon, , France
Centre Hospitalier Saint Joseph Saint Luc
Lyon, , France
Cabinet médical Dr C. CORNUT-CHAUVINC
Lyon, , France
Hopital Timone Adultes
Marseille, , France
Hopital Gui de Chauliac
Montpellier, , France
Cabinet médical Dr L. GUILLOTON
Mornant, , France
Hôpital Central
Nancy, , France
Hopital Pasteur
Nice, , France
Hopital Caremeau
Nîmes, , France
Hôpital Paris Saint Joseph
Paris, , France
Fondation Rotschild
Paris, , France
Hôpital national des Quinze-Vingt.
Paris, , France
Hopital Pitie Salpetriere
Paris, , France
Chi Poissy Saint Germain En Laye
Poissy, , France
Chr La Miletrie
Poitiers, , France
Hopital Rene Dubos
Pontoise, , France
Hopital Pontchaillou
Rennes, , France
Hôpital Charles-Nicolle
Rouen, , France
Centre Hospitalier de Saint-Denis
Saint-Denis, , France
Hopital G. Et R. Laennec
Saint-Herblain, , France
Centre Hospitalier Mémorial
Saint-Lô, , France
Hopital Nord
Saint-Priest-en-Jarez, , France
Hopital Hautepierre
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Hopital Purpan
Toulouse, , France
Chru de Tours Hopital Bretonneau
Tours, , France
Médipôle Lyon Villeurbanne
Villeurbanne, , France
Hopital P. Zobda-Quitman
Fort-de-France, , Martinique
Countries
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Central Contacts
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Facility Contacts
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Abdullatif AL KHEDR
Role: primary
Nathalie MOREL
Role: primary
Patricia TOURNAIRE
Role: primary
Eric BERGER
Role: primary
Aurélie RUET
Role: primary
Alexis MONTCUQUET
Role: primary
Pierre BRANGER
Role: primary
Clara GROSSET-JANIN
Role: primary
Pierre CLAVELOU
Role: primary
Alain CREANGE
Role: primary
Thibault MOREAU
Role: primary
Evelyne PLANQUE
Role: primary
Ayman TOURBAH
Role: primary
Eric MANCHON
Role: primary
Olivier CASEZ
Role: primary
Chantal NIEFLE
Role: primary
Arnaud KWIATKOWSKI
Role: primary
Hélène ZEPHIR
Role: primary
Laurent MAGY
Role: primary
Philippe NEUSCHWANDER
Role: primary
Amandine BENOIT
Role: primary
Catherine CORNUT- CHAUVINC
Role: primary
Jean PELLETIER
Role: primary
Pierre LABAUGE
Role: primary
Laurent GUILLOTON
Role: primary
Guillaume MATHEY
Role: primary
Christine LEBRUN-FRENAY
Role: primary
Eric THOUVENOT
Role: primary
Hélène BRASME
Role: primary
Caroline BENSA-KOSCHER
Role: primary
Dalia DIMITRI BOULOS
Role: primary
Elisabeth MAILLART
Role: primary
Olivier HEINZLEF
Role: primary
Amélie DOS SANTO
Role: primary
Corinne DUPEL-POTTIER
Role: primary
Laure MICHEL
Role: primary
Bertrand BOURRE
Role: primary
Thomas DEBROUCKER
Role: primary
David LAPLAUD
Role: primary
Lydie DUBUC-LEPETIT
Role: primary
Jean-Philippe CAMDESSANCHE
Role: primary
Jérôme DE SEZE
Role: primary
Maya TCHIKVILADZE
Role: primary
Jonathan CIRON
Role: primary
Ines DOGHRI
Role: primary
Pékès CODJA
Role: primary
Thomas DAVID
Role: primary
Related Links
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Related Info
Other Identifiers
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2018-A02552-53
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL18_0631
Identifier Type: -
Identifier Source: org_study_id
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