French Registry for Monitoring Pregnancies for Multiple Sclerosis
RESPONSE
2 other identifiers
observational
1,500
2 countries
48
Brief 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…)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Longer than P75 for all trials
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
August 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 12, 2036
January 5, 2026
December 1, 2025
17 years
March 8, 2019
December 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during pregnancy period
Description of the current neurological practice of French neurologists regarding disease modifying drugs and desire of pregnancy and evaluation of its short term impact on the risk of relapses.
up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during post-partum period
Description of the current neurological practice of French neurologists regarding disease modifying drugs and desire of pregnancy and evaluation of its short term impact on the risk of relapses.
up to 2 years
Study Arms (1)
Pregnant women with multiple sclerosis or related neurological
Children born to women with multiple sclerosis or related neurological syndromes.
Interventions
Eligibility Criteria
Pregnant women with multiple sclerosis or related neurological syndromes
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)
- Able to give informed consent
- Able to read and/or understand French
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Chu D'Amiens
Amiens, 80054, France
Centre Hospitalier Annecy Genevois
Annecy, 74000, France
Centre Hospitalier d'Avignon
Avignon, 84000, France
Hopital Jean Minjoz
Besançon, 25030, France
Hopital Pellegrin
Bordeaux, 33076, France
Hôpital de Brive
Brive-la-Gaillarde, 19100, France
Hôpital Neurologique Pierre Wertheimer
Bron, 69677, France
Hopital Cote de Nacre
Caen, 14033, France
Centre hospitalier Métropole Savoie
Chambéry, 73000, France
Hopital Gabriel Montpied
Clermont-Ferrand, 63003, France
Hopital Henri Mondor
Créteil, 94010, France
Hopital Du Bocage
Dijon, 21079, France
Ch Epinal
Épinal, 88000, France
Hôpital Raymond Poincaré
Garches, 92380, France
Centre hospitalier Joséphine Baker Gonesse
Gonesse, 95500, France
Chu de Grenoble
Grenoble, 38043, France
Centre Hospitalier de Versailles Hôpital Andre Mignot
Le Chesnay, 78157, France
Hôpital St Vincent De Paul
Lille, 59020, France
Chru de Lille
Lille, 59037, France
Hopital Dupuytren
Limoges, 87042, France
Cabinet médical Dr Philippe NEUSCHWANDER
Lyon, 69006, France
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007, France
Cabinet médical Dr C. CORNUT-CHAUVINC
Lyon, 69008, France
Hopital Timone Adultes
Marseille, 13385, France
Hopital Gui de Chauliac
Montpellier, 34295, France
Cabinet médical Dr L. GUILLOTON
Mornant, 69440, France
Hôpital Central
Nancy, 54035, France
Hopital Pasteur
Nice, 06001, France
Hopital Caremeau
Nîmes, 30029, France
Hôpital Paris Saint Joseph
Paris, 75014, France
Fondation Rotschild
Paris, 75019, France
Hôpital national des Quinze-Vingt.
Paris, 75571, France
Hopital Pitie Salpetriere
Paris, 75651, France
Chi Poissy Saint Germain En Laye
Poissy, 78303, France
Chr La Miletrie
Poitiers, 86021, France
Hopital Rene Dubos
Pontoise, 95300, France
Hopital Pontchaillou
Rennes, 35033, France
Hôpital Charles-Nicolle
Rouen, 76000, France
Centre Hospitalier de Saint-Denis
Saint-Denis, 93200, France
Hopital G. Et R. Laennec
Saint-Herblain, 44800, France
Centre Hospitalier Mémorial
Saint-Lô, 50009, France
Hopital Nord
Saint-Priest-en-Jarez, 42277, France
Hopital Hautepierre
Strasbourg, 67098, France
Hôpital Foch
Suresnes, 92151, France
Hopital Purpan
Toulouse, 31059, France
Chru de Tours Hopital Bretonneau
Tours, 37044, France
Médipôle Lyon Villeurbanne
Villeurbanne, 69100, France
Hopital P. Zobda-Quitman
Fort-de-France, 97200, Martinique
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra VUKUSIC, Prof.
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2019
First Posted
April 2, 2019
Study Start
August 12, 2019
Primary Completion (Estimated)
August 12, 2036
Study Completion (Estimated)
August 12, 2036
Last Updated
January 5, 2026
Record last verified: 2025-12