French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort

Status: Recruiting
Location: See all (46) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu D'Amiens
RECRUITING
Amiens
Centre Hospitalier Annecy Genevois
RECRUITING
Annecy
Centre Hospitalier d'Avignon
RECRUITING
Avignon
Hopital Jean Minjoz
RECRUITING
Besançon
Hopital Pellegrin
RECRUITING
Bordeaux
Hôpital Neurologique Pierre Wertheimer
RECRUITING
Bron
Hopital Cote de Nacre
RECRUITING
Caen
Centre hospitalier Métropole Savoie
RECRUITING
Chambéry
Hopital Gabriel Montpied
RECRUITING
Clermont-ferrand
Hopital Henri Mondor
RECRUITING
Créteil
Hopital Du Bocage
RECRUITING
Dijon
Ch Epinal
RECRUITING
Épinal
Hôpital Raymond Poincaré
RECRUITING
Garches
Chu de Grenoble
RECRUITING
Grenoble
Centre Hospitalier de Versailles Hôpital Andre Mignot
RECRUITING
Le Chesnay
Chru de Lille
RECRUITING
Lille
Hôpital St Vincent De Paul
RECRUITING
Lille
Hopital Dupuytren
RECRUITING
Limoges
Cabinet médical Dr C. CORNUT-CHAUVINC
RECRUITING
Lyon
Cabinet médical Dr Philippe NEUSCHWANDER
RECRUITING
Lyon
Centre Hospitalier Saint Joseph Saint Luc
RECRUITING
Lyon
Hopital Timone Adultes
RECRUITING
Marseille
Hopital Gui de Chauliac
RECRUITING
Montpellier
Cabinet médical Dr L. GUILLOTON
RECRUITING
Mornant
Hôpital Central
RECRUITING
Nancy
Hopital Pasteur
RECRUITING
Nice
Hopital Caremeau
RECRUITING
Nîmes
Fondation Rotschild
RECRUITING
Paris
Hôpital national des Quinze-Vingt.
RECRUITING
Paris
Hôpital Paris Saint Joseph
RECRUITING
Paris
Hopital Pitie Salpetriere
RECRUITING
Paris
Chi Poissy Saint Germain En Laye
RECRUITING
Poissy
Chr La Miletrie
RECRUITING
Poitiers
Hopital Rene Dubos
RECRUITING
Pontoise
Hopital Pontchaillou
RECRUITING
Rennes
Hôpital Charles-Nicolle
RECRUITING
Rouen
Centre Hospitalier de Saint-Denis
RECRUITING
Saint-denis
Hopital G. Et R. Laennec
RECRUITING
Saint-herblain
Centre Hospitalier Mémorial
RECRUITING
Saint-lô
Hopital Nord
RECRUITING
Saint-priest-en-jarez
Hopital Hautepierre
RECRUITING
Strasbourg
Hôpital Foch
RECRUITING
Suresnes
Hopital Purpan
RECRUITING
Toulouse
Chru de Tours Hopital Bretonneau
RECRUITING
Tours
Médipôle Lyon Villeurbanne
RECRUITING
Villeurbanne
Martinique
Hopital P. Zobda-Quitman
RECRUITING
Fort-de-france
Contact Information
Primary
Sandra VUKUSIC, Prof.
sandra.vukusic@chu-lyon.fr
4 72 68 13 13
Backup
Romain MARIGNIER, MD
romain.marignier@chu-lyon.fr
4 72 68 13 13
Time Frame
Start Date: 2019-08-12
Estimated Completion Date: 2036-08-12
Participants
Target number of participants: 1500
Treatments
Pregnant women with multiple sclerosis or related neurological
Children born to women with multiple sclerosis or related neurological syndromes.
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov