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Monitoring pregnancies in women with 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

Observational Hospices Civils de Lyon · NCT03900221

This study is trying to see how pregnancy affects women with multiple sclerosis and their babies, while also looking at treatments and breastfeeding.

Quick facts

Study typeObservational
Enrollment1500 (estimated)
SexAll
SponsorHospices Civils de Lyon Academic / other
Locations48 sites (Amiens and 47 other locations)
Trial IDNCT03900221 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include women with a confirmed diagnosis of multiple sclerosis or related disorders who are currently pregnant.

Not a fit: Patients who are not pregnant or those with conditions unrelated to multiple sclerosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how pregnancy affects multiple sclerosis and improve care for pregnant women with the condition.

How similar studies have performed: Previous studies have indicated the importance of understanding the relationship between pregnancy and multiple sclerosis, but this specific registry approach is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Amiens and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sclerosis, MultipleNeuromyelitis Optica Spectrum DisorderMyelin Oligodendrocyte Glycoprotein-Antibody Related DisordersPregnancy AbnormalMultiple sclerosispregnancydisease modifying drugsbreastfeeding
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.