Clinical trial NCT03900221: French Registry for Monitoring Pregnancies for Multiple Sclerosis
Official title: French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sclerosis, Multiple
Neuromyelitis Optica Spectrum Disorder
Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders
Pregnancy Abnormal
Keywords: Multiple sclerosis
pregnancy
disease modifying drugs
breastfeeding
loco-regional analgesia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with multiple sclerosis or related neurological syndromes

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...)

Detailed description: METHODOLOGY Prospective, observational, multicentric and national epidemiological study, within the scope of the OFSEP, including all groups of patients eligible to participate in the Observatoire Français de la Sclérose en Plaque (OFSEP) (definite MS, radiologically isolated syndromes, clinically isolated syndromes, neuromyelitis optica (NMO) and NMO spectrum disorders), with no age limit and an ongoing pregnancy. Women will be followed during pregnancy and in the year after and their children until 6 years of age.

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.

Eligibility criteria: 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during pregnancy period
timeFrame: up to 2 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during post-partum period
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu D'Amiens
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon
city: Besançon
country: France
facility: Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Bron
country: France
facility: Hôpital Neurologique Pierre Wertheimer
city: Caen
country: France
facility: Hopital Cote de Nacre
city: Chambéry
country: France
facility: Centre hospitalier Métropole Savoie
city: Clermont-Ferrand
country: France
facility: Hopital Gabriel Montpied
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: Hopital Du Bocage
city: Epinal
country: France
facility: Ch Epinal
city: Garches
country: France
facility: Hôpital Raymond Poincaré
city: Grenoble
country: France
facility: Chu de Grenoble
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles Hôpital Andre Mignot
city: Lille
country: France
facility: Hôpital St Vincent De Paul
city: Lille
country: France
facility: Chru de Lille
city: Limoges
country: France
facility: Hopital Dupuytren
city: Lyon
country: France
facility: Cabinet médical Dr Philippe NEUSCHWANDER
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Lyon
country: France
facility: Cabinet médical Dr C. CORNUT-CHAUVINC
city: Marseille
country: France
facility: Hopital Timone Adultes
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
city: Mornant
country: France
facility: Cabinet médical Dr L. GUILLOTON
city: Nancy
country: France
facility: Hôpital Central
city: Nice
country: France
facility: Hopital Pasteur
city: Nîmes
country: France
facility: Hopital Caremeau
city: Paris
country: France
facility: Hôpital Paris Saint Joseph
city: Paris
country: France
facility: Fondation Rotschild
city: Paris
country: France
facility: Hôpital national des Quinze-Vingt.
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Poissy
country: France
facility: Chi Poissy Saint Germain En Laye
city: Poitiers
country: France
facility: Chr La Miletrie
city: Pontoise
country: France
facility: Hopital Rene Dubos
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles-Nicolle
city: Saint-Denis
country: France
facility: Centre Hospitalier de Saint-Denis
city: Saint-Herblain
country: France
facility: Hopital G. Et R. Laennec
city: Saint-Lô
country: France
facility: Centre Hospitalier Mémorial
city: Saint-Priest-en-Jarez
country: France
facility: Hopital Nord
city: Strasbourg
country: France
facility: Hopital Hautepierre
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: Hopital Purpan
city: Tours
country: France
facility: Chru de Tours Hopital Bretonneau
city: Villeurbanne
country: France
facility: Médipôle Lyon Villeurbanne
city: Fort-de-France
country: Martinique
facility: Hopital P. Zobda-Quitman
Study officials:
affiliation: Hospices Civils de Lyon
name: Sandra VUKUSIC, Prof.
role: PRINCIPAL_INVESTIGATOR
References: