Actively Recruiting
French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort
Led by Hospices Civils de Lyon · Updated on 2026-01-05
1500
Participants Needed
48
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand how pregnancy affects women with multiple sclerosis (MS) and related neurological conditions, including neuromyelitis optica and myelin oligodendrocyte glycoprotein antibody-related disorders. The study focuses on important questions about the use of disease-modifying drugs during pregnancy, the effects on the mother's health and disability, the child's health, breastfeeding, and pain management during delivery. It is a national, prospective, observational study conducted within the French MS cohort called Observatoire Français de la Sclérose en Plaque (OFSEP). Women with MS or related disorders who are pregnant will be followed throughout their pregnancy and for one year after giving birth. Their children will also be monitored until they reach six years of age. There is no intervention or treatment given as part of this study; instead, it collects detailed information on the course of MS during pregnancy and postpartum, including any use or discontinuation of disease-modifying drugs and other pregnancy-related factors. Participants will have regular follow-ups during pregnancy and postpartum to assess their health and any treatment-related side effects. Researchers will collect data on relapses, disability progression, breastfeeding, and use of pain relief during delivery. Children born to these women will be observed for up to six years to evaluate long-term outcomes. The main outcomes measured include the number of treatment-related adverse events during pregnancy and postpartum, helping to improve knowledge for neurologists and families regarding MS and pregnancy.
CONDITIONS
Brief Title
French Registry for Monitoring Pregnancies for Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients eligible to participate in the Observatoire Français de la Sclérose en Plaque (OFSEP), including definite multiple sclerosis (MS) diagnosed by McDonald criteria
- Any clinical course of MS (single attack, relapsing-remitting, secondary progressive, primary progressive)
- Radiologically Isolated Syndromes (RIS) validated by expert group
- Clinically Isolated Syndromes (CIS)
- Neuromyelitis optica (NMO) and NMO spectrum disorders validated by expert group
- No age limit; patients under 18 may participate with parental consent
- Currently pregnant at any stage of gestation
- Able to give informed consent
- Able to read and/or understand French
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 7 years
Participants who are pregnant with multiple sclerosis or related neurological syndromes are observed during pregnancy and in the year after delivery, and their children are followed until 6 years of age.
Trial Site Locations
Total: 48 locations
1
Chu D'Amiens
Amiens, France, 80054
Actively Recruiting
2
Centre Hospitalier Annecy Genevois
Annecy, France, 74000
Actively Recruiting
3
Centre Hospitalier d'Avignon
Avignon, France, 84000
Actively Recruiting
4
Hopital Jean Minjoz
Besançon, France, 25030
Actively Recruiting
5
Hopital Pellegrin
Bordeaux, France, 33076
Actively Recruiting
6
Hôpital de Brive
Brive-la-Gaillarde, France, 19100
Actively Recruiting
7
Hôpital Neurologique Pierre Wertheimer
Bron, France, 69677
Actively Recruiting
8
Hopital Cote de Nacre
Caen, France, 14033
Actively Recruiting
9
Centre hospitalier Métropole Savoie
Chambéry, France, 73000
Actively Recruiting
10
Hopital Gabriel Montpied
Clermont-Ferrand, France, 63003
Actively Recruiting
11
Hopital Henri Mondor
Créteil, France, 94010
Actively Recruiting
12
Hopital Du Bocage
Dijon, France, 21079
Actively Recruiting
13
Ch Epinal
Épinal, France, 88000
Actively Recruiting
14
Hôpital Raymond Poincaré
Garches, France, 92380
Actively Recruiting
15
Centre hospitalier Joséphine Baker Gonesse
Gonesse, France, 95500
Actively Recruiting
16
Chu de Grenoble
Grenoble, France, 38043
Actively Recruiting
17
Centre Hospitalier de Versailles Hôpital Andre Mignot
Le Chesnay, France, 78157
Actively Recruiting
18
Hôpital St Vincent De Paul
Lille, France, 59020
Actively Recruiting
19
Chru de Lille
Lille, France, 59037
Actively Recruiting
20
Hopital Dupuytren
Limoges, France, 87042
Actively Recruiting
21
Cabinet médical Dr Philippe NEUSCHWANDER
Lyon, France, 69006
Actively Recruiting
22
Centre Hospitalier Saint Joseph Saint Luc
Lyon, France, 69007
Actively Recruiting
23
Cabinet médical Dr C. CORNUT-CHAUVINC
Lyon, France, 69008
Actively Recruiting
24
Hopital Timone Adultes
Marseille, France, 13385
Actively Recruiting
25
Hopital Gui de Chauliac
Montpellier, France, 34295
Actively Recruiting
26
Cabinet médical Dr L. GUILLOTON
Mornant, France, 69440
Actively Recruiting
27
Hôpital Central
Nancy, France, 54035
Actively Recruiting
28
Hopital Pasteur
Nice, France, 06001
Actively Recruiting
29
Hopital Caremeau
Nîmes, France, 30029
Actively Recruiting
30
Hôpital Paris Saint Joseph
Paris, France, 75014
Actively Recruiting
31
Fondation Rotschild
Paris, France, 75019
Actively Recruiting
32
Hôpital national des Quinze-Vingt.
Paris, France, 75571
Actively Recruiting
33
Hopital Pitie Salpetriere
Paris, France, 75651
Actively Recruiting
34
Chi Poissy Saint Germain En Laye
Poissy, France, 78303
Actively Recruiting
35
Chr La Miletrie
Poitiers, France, 86021
Actively Recruiting
36
Hopital Rene Dubos
Pontoise, France, 95300
Actively Recruiting
37
Hopital Pontchaillou
Rennes, France, 35033
Actively Recruiting
38
Hôpital Charles-Nicolle
Rouen, France, 76000
Actively Recruiting
39
Centre Hospitalier de Saint-Denis
Saint-Denis, France, 93200
Actively Recruiting
40
Hopital G. Et R. Laennec
Saint-Herblain, France, 44800
Actively Recruiting
41
Centre Hospitalier Mémorial
Saint-Lô, France, 50009
Actively Recruiting
42
Hopital Nord
Saint-Priest-en-Jarez, France, 42277
Actively Recruiting
43
Hopital Hautepierre
Strasbourg, France, 67098
Actively Recruiting
44
Hôpital Foch
Suresnes, France, 92151
Actively Recruiting
45
Hopital Purpan
Toulouse, France, 31059
Actively Recruiting
46
Chru de Tours Hopital Bretonneau
Tours, France, 37044
Actively Recruiting
47
Médipôle Lyon Villeurbanne
Villeurbanne, France, 69100
Actively Recruiting
48
Hopital P. Zobda-Quitman
Fort-de-France, Martinique, 97200
Actively Recruiting
Research Team
S
Sandra VUKUSIC, Prof.
R
Romain MARIGNIER, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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