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Pregnancy Cohort in Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT05010902
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Anja Maehler, Charite University, Berlin, Germany

Study Description
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Brief Summary:
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.

Condition or disease
Multiple Sclerosis (MS) Clinically Isolated Syndrome (CIS)

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pregnancy Cohort in Multiple Sclerosis (MS)
Actual Study Start Date : January 1, 2013
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Multiple sclerosis
Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis


Outcome Measures
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Primary Outcome Measures :
  1. Time until relapse [ Time Frame: 12 months after delivery compared to baseline ]
    Time (in days) until relapse during the observation period


Secondary Outcome Measures :
  1. Number of T2 lesions [ Time Frame: 12 months after delivery compared to baseline ]
    Number of T2 lesions in spinal and cerebral magnetic resonance imaging

  2. Number of gadolinium enhancing lesions [ Time Frame: 12 months after delivery compared to baseline ]
    Number of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging

  3. Volume of T2 lesions [ Time Frame: 12 months after delivery compared to baseline ]
    Volume of T2 lesions in spinal and cerebral magnetic resonance imaging

  4. Volume of gadolinium enhancing lesions [ Time Frame: 12 months after delivery compared to baseline ]
    Volume of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging

  5. Change in immune cell phenotypes [ Time Frame: 12 months after delivery compared to baseline ]
    Change in immune cell phenotypes of peripheral blood mononuclear cells (PBMC)

  6. Galectin-1 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in serum galectin-1 concentration measured by ELISA

  7. Galectin-3 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in serum galectin-3 concentration measured by ELISA

  8. Galectin-9 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in serum galectin-9 concentration measured by ELISA

  9. Neurofilament (NfL) [ Time Frame: 12 months after delivery compared to baseline ]
    Change in neurofilament serum concentration by using Simoa NfL assay

  10. Pro-inflammatory interleukin-17 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in interleukin-17 serum concentration assessed by ELISA

  11. Anti-inflammatory interleukin-10 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in anti-inflammatory interleukin-10 serum concentration assessed by ELISA

  12. Autoantibody profiling [ Time Frame: 12 months after delivery compared to baseline ]
    Identification and quantification of autoantibodies by using protein microarray and ELISA

  13. Fecal microbiome composition [ Time Frame: 12 months after delivery compared to baseline ]
    Composition of fecal microbiome measured by 16S Sequencing

  14. Thickness of the retinal nerve fibre layer [ Time Frame: 12 months after delivery (compared to baseline) ]
    Thickness of the retinal nerve fibre layer by Optical Coherence Tomography (OCT)

  15. Total macular volume (TMV) [ Time Frame: 12 months after delivery compared to baseline ]
    Total macular volume by Optical Coherence Tomography (OCT)

  16. Mini-International Neuropsychiatric Interview (M.I.N.I.) German Version 5.0.0 Module A-C [ Time Frame: 12 months after delivery compared to baseline ]
    Structured diagnostic interview to assess depression, dysthymia and suicidality

  17. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 months after delivery compared to baseline ]
    Rating of ten depression related symptoms on a scale from 0 to 6 (higher numbers indicate more severe symptoms)

  18. Beck Depression Inventory (BDI-II) [ Time Frame: 12 months after delivery compared to baseline ]
    Rating of 21 depression related symptoms on a scale from 0 to 3 (higher numbers indicate more severe symptoms)

  19. Edinburgh Postpartum Depression Scale (EPDS) [ Time Frame: 12 months after delivery compared to baseline ]
    Self-report survey containing 10 items, each item is rated 0-3 (higher scores indicate a higher probability of postpartum depression)

  20. Modified Fatigue Inventory Scale (MFIS) [ Time Frame: 12 months after delivery compared to baseline ]
    Self-report survey containing 21 items, each item is rated 0-4 (higher scores indicate a greater impact of fatigue on a person's activities)

  21. Fatigue Severity Scale (FSS) [ Time Frame: 12 months after delivery compared to baseline ]
    A self-report survey consisting of 11 items, each item ranges from 1 to 7 (higher scores indicate higher levels of fatigue)

  22. Visual Fatigue Analogue Scale (VFAS) [ Time Frame: 12 months after delivery compared to baseline ]
    A self-administered, single scale indication measuring visual fatigue, ranging from 0 to 100 (higher scores indicate worse fatigue)

  23. Short-Form Health Survey (SF-36) [ Time Frame: 12 months after delivery compared to baseline ]
    A self-report survey measuring health in eight dimensions (higher scores indicate less disability)


Biospecimen Retention:   Samples With DNA
Stool and blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruted at neurological outpatient clinics and neurological clinics of the Charité and neurologists' medical practices.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05010902


Contacts
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Contact: Nadja Siebert, MD nadja.siebert@charite.de
Contact: Friedemann Paul, Prof. friedemann.paul@charite.de

Locations
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Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13125
Contact: Nadja Siebert, MD       nadja.siebert@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Anja Mähler, PhD Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin
More Information
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Responsible Party: Anja Maehler, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT05010902    
Other Study ID Numbers: PreCoMS
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication
Access Criteria: Researchers who provide a methodologically sound proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anja Maehler, Charite University, Berlin, Germany:
Pregnancy
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases