Informations générales (source: ClinicalTrials.gov)
French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort (RESPONSE)
Observational [Patient Registry]
Hospices Civils de Lyon (Voir sur ClinicalTrials)
août 2019
août 2036
29 juin 2024
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...)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER SUD FRANCILIEN | POTTIER | 09/06/2024 11:48:13 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Caroline BENSA | 21/06/2024 13:32:59 | Contacter | ||
| HOPITAL NOVO | POTTIER | 04/07/2024 11:05:05 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Alain CREANGE | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital La Pitié-Salpêtrière | Catherine LUBETZKI | Contact (sur clinicalTrials) | |||
| CENTRE DE CRISE SAINT DENIS | Thomas DEBROUCKER | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Chantal NIEFLE | Contact (sur clinicalTrials) | |||
| CHI POISSY ST-GERMAIN | Olivier HEINZLEF | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chr La Miletrie - 86021 - Poitiers - France | Jean-Philippe NEAU | Contact (sur clinicalTrials) | |||
| Chru de Tours Hopital Bretonneau - 37044 - Tours - France | Anne-Marie GUENNOC | Contact (sur clinicalTrials) | |||
| Hopital Caremeau - 30029 - Nîmes - France | Eric THOUVENOT | Contact (sur clinicalTrials) | |||
| Hôpital Central - 54035 - Nancy - France | Marc DEBOUVERIE | Contact (sur clinicalTrials) | |||
| Hopital Cote de Nacre - 14033 - Caen - France | Gilles DEFER | Contact (sur clinicalTrials) | |||
| Hopital de La Maison Blanche - 51092 - Reims - France | Ayman TOURBAH | Contact (sur clinicalTrials) | |||
| Hopital Du Bocage - 21079 - Dijon - France | Thibault MOREAU | Contact (sur clinicalTrials) | |||
| Hopital Dupuytren - 87042 - Limoges - France | Laurent MAGY | Contact (sur clinicalTrials) | |||
| Hopital Gabriel Montpied - 63003 - Clermont-Ferrand - France | Pierre CLAVELOU | Contact (sur clinicalTrials) | |||
| Hopital Gui de Chauliac - 34295 - Montpellier - France | Pierre LABAUGE | Contact (sur clinicalTrials) | |||
| Hopital Hautepierre - 67098 - Strasbourg - France | Jérôme DE SEZE | Contact (sur clinicalTrials) | |||
| Hopital Jean Minjoz - 25030 - Besançon - France | Eric BERGER | Contact (sur clinicalTrials) | |||
| Hôpital Neurologique Pierre Wertheimer - 69677 - Bron - France | Sandra VUKUSIC | Contact (sur clinicalTrials) | |||
| Hopital Pasteur - 06001 - Nice - France | Christine LEBRUN-FRENAY | Contact (sur clinicalTrials) | |||
| Hopital Pellegrin - 33076 - Bordeaux - France | Bruno BROCHET | Contact (sur clinicalTrials) | |||
| Hopital Purpan - 31059 - Toulouse - France | David BRASSAT | Contact (sur clinicalTrials) | |||
| Hopital Saint Antoine - 75570 - Paris - France | Bruno STANKOFF | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chru de Lille - 59037 - Lille - France | Patrick VERMERSCH | Contact (sur clinicalTrials) | |||
| Chu D'Amiens - 80054 - Amiens - France | Abdullatif AL KHEDR | Contact (sur clinicalTrials) | |||
| Chu de Grenoble - 38043 - Grenoble - France | Olivier CASEZ | Contact (sur clinicalTrials) | |||
| Fondation Rotschild - 75019 - Paris - France | Olivier GOUT | Contact (sur clinicalTrials) | |||
| Hopital G. Et R. Laennec - 44800 - Saint-Herblain - France | David LAPLAUD | Contact (sur clinicalTrials) | |||
| Hopital Nord - 42277 - Saint-Priest-en-Jarez - France | Jean-Philippe CAMDESSANCHE | Contact (sur clinicalTrials) | |||
| Hopital Pontchaillou - 35033 - Rennes - France | Gilles EDAN | Contact (sur clinicalTrials) | |||
| Hopital Timone Adultes - 13385 - Marseille - France | Jean PELLETIER | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- None