Monitoring pregnancies in women with multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to establish a national pregnancy registry for women with multiple sclerosis (MS) in France. It will follow patients with various forms of MS, including neuromyelitis optica spectrum disorders, throughout their pregnancy and for one year postpartum, as well as tracking their children until the age of six. The study seeks to gather data on the effects of pregnancy on MS, the use of disease-modifying drugs, breastfeeding, and locoregional analgesia. By analyzing these interactions, the study aims to provide valuable insights for neurologists and patients regarding the management of MS during pregnancy.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu D'Amiens
  Amiens, France Recruiting
• Centre Hospitalier Annecy Genevois
  Annecy, France Recruiting
• Centre Hospitalier d'Avignon
  Avignon, France Recruiting
• Hopital Jean Minjoz
  Besançon, France Recruiting
• Hopital Pellegrin
  Bordeaux, France Recruiting
• Hôpital de Brive
  Brive-la-Gaillarde, France Recruiting

Study contacts

• Principal investigator: Sandra VUKUSIC, Prof. — Hospices Civils de Lyon
• Study coordinator: Sandra VUKUSIC, Prof.
• Email: sandra.vukusic@chu-lyon.fr
• Phone: 4 72 68 13 13

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.