NCT03900221Recruiting
French Registry for Monitoring Pregnancies for Multiple Sclerosis
French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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…)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 8 Mar 2019
- Start date
- 12 Aug 2019
- Primary completion date
- 12 Aug 2036
- Lead sponsor
- Hospices Civils de Lyon
- NCT number
- NCT03900221
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 12 Aug 2019 to the primary completion date, 12 Aug 2036
- 48 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU D'amiens Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Annecy | France | Recruiting |
| Centre Hospitalier d'Avignon Coordinator of this site? Confirm its status | Avignon | France | Recruiting |
| Hopital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Hopital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Hôpital de Brive Coordinator of this site? Confirm its status | Brive-la-Gaillarde | France | Recruiting |
| Hôpital Neurologique Pierre Wertheimer Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Hôpital Côte De Nacre Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Centre Hospitalier Métropole Savoie Coordinator of this site? Confirm its status | Chambéry | France | Recruiting |
| Hopital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Hopital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Hopital Du Bocage Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Ch Epinal Coordinator of this site? Confirm its status | Épinal | France | Recruiting |
| Hôpital Raymond-Poincaré Coordinator of this site? Confirm its status | Garches | France | Recruiting |
| Centre hospitalier Joséphine Baker Gonesse Coordinator of this site? Confirm its status | Gonesse | France | Recruiting |
| CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Centre Hospitalier de Versailles Hôpital Andre Mignot Coordinator of this site? Confirm its status | Le Chesnay | France | Recruiting |
| CHRU de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hôpital St Vincent de Paul Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hopital Dupuytren Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Cabinet médical Dr C. CORNUT-CHAUVINC Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Hospitalier Saint Joseph Saint Luc Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Cabinet médical Dr Philippe NEUSCHWANDER Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hopital Timone Adultes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hôpital Gui de Chauliac Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Cabinet médical Dr L. GUILLOTON Coordinator of this site? Confirm its status | Mornant | France | Recruiting |
| Hôpital Central, Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| Hopital PASTEUR Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Hopital Caremeau Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital national des Quinze-Vingt. Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Fondation Rotschild Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Paris Saint Joseph Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHI Poissy-Saint-Germain en Laye Coordinator of this site? Confirm its status | Poissy | France | Recruiting |
| Chr La Miletrie Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Hopital Rene Dubos Coordinator of this site? Confirm its status | Pontoise | France | Recruiting |
| Hôpital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Centre Hospitalier de Saint-Denis Coordinator of this site? Confirm its status | Saint-Denis | France | Recruiting |
| Hopital G. Et R. Laennec Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Centre Hospitalier Mémorial Coordinator of this site? Confirm its status | Saint-Lô | France | Recruiting |
| Hopital Nord Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Hopital Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| Hopital Purpan Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHRU de Tours- Hopital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| Médipôle Lyon-Villeurbanne Coordinator of this site? Confirm its status | Villeurbanne | France | Recruiting |
| Hopital P. Zobda-Quitman Coordinator of this site? Confirm its status | Fort-de-France | Martinique | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.