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Recruiting NCT05010902

Pregnancy Cohort in Multiple Sclerosis (MS)

— Observational Multiple Sclerosis (MS) Clinically Isolated Syndrome (CIS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis (MS), Clinically Isolated Syndrome (CIS). Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Multiple sclerosis (MS) is a common inflammatory demyelinating disorder of the central nervous system frequently affecting females in their reproductive phase of life. In this prospective observational study, we obtain data on the outcome of pregnancies in MS patients and the influence of pregnancy on clinical, laboratory and MRI parameters in MS.

Primary outcome measures

  • Time until relapse [Time frame: 12 months after delivery compared to baseline]
Secondary outcome measures (12)
  • Number of T2 lesions [Time frame: 12 months after delivery compared to baseline]
  • Number of gadolinium enhancing lesions [Time frame: 12 months after delivery compared to baseline]
  • Volume of T2 lesions [Time frame: 12 months after delivery compared to baseline]
  • Volume of gadolinium enhancing lesions [Time frame: 12 months after delivery compared to baseline]
  • Change in immune cell phenotypes [Time frame: 12 months after delivery compared to baseline]
  • Galectin-1 [Time frame: 12 months after delivery compared to baseline]
  • Galectin-3 [Time frame: 12 months after delivery compared to baseline]
  • Galectin-9 [Time frame: 12 months after delivery compared to baseline]
  • Neurofilament (NfL) [Time frame: 12 months after delivery compared to baseline]
  • Pro-inflammatory interleukin-17 [Time frame: 12 months after delivery compared to baseline]
  • Anti-inflammatory interleukin-10 [Time frame: 12 months after delivery compared to baseline]
  • Autoantibody profiling [Time frame: 12 months after delivery compared to baseline]

Eligibility criteria

Inclusion criteria

  • age > 18 years
  • signed informed consent
  • diagnosis of multiple sclerosis or clinically isolated syndrome

Exclusion criteria

  • clinically relevant comorbidities
  • contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
  • alcohol or drug abuse

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Charité Universitätsmedizin Berlin — Berlin

Identifiers

NCT: NCT05010902 · PreCoMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗