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NCT Number: NCT05010902

Pregnancy Cohort in Multiple Sclerosis (MS)

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.

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Clinically Isolated Syndrome (CIS) Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Charité Universitätsmedizin Berlin

Berlin, 13125, Germany

Location status: Recruiting

Location contact

Nadja Siebert, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time until relapse

    Time frame: 12 months after delivery compared to baseline

    Time (in days) until relapse during the observation period

Secondary outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Friedemann Paul, Prof.

CONTACT

[email protected]

Nadja Siebert, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2013
Primary completion
2025
Study completion
2026
First posted
Aug 18, 2021
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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