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.
Study Type
OBSERVATIONAL
Enrollment
100
Charité Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGTime until relapse
Time (in days) until relapse during the observation period
Time frame: 12 months after delivery compared to baseline
Number of T2 lesions
Number of T2 lesions in spinal and cerebral magnetic resonance imaging
Time frame: 12 months after delivery compared to baseline
Number of gadolinium enhancing lesions
Number of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
Time frame: 12 months after delivery compared to baseline
Volume of T2 lesions
Volume of T2 lesions in spinal and cerebral magnetic resonance imaging
Time frame: 12 months after delivery compared to baseline
Volume of gadolinium enhancing lesions
Volume of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
Time frame: 12 months after delivery compared to baseline
Change in immune cell phenotypes
Change in immune cell phenotypes of peripheral blood mononuclear cells (PBMC)
Time frame: 12 months after delivery compared to baseline
Galectin-1
Change in serum galectin-1 concentration measured by ELISA
Time frame: 12 months after delivery compared to baseline
Galectin-3
Change in serum galectin-3 concentration measured by ELISA
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Time frame: 12 months after delivery compared to baseline
Galectin-9
Change in serum galectin-9 concentration measured by ELISA
Time frame: 12 months after delivery compared to baseline
Neurofilament (NfL)
Change in neurofilament serum concentration by using Simoa NfL assay
Time frame: 12 months after delivery compared to baseline
Pro-inflammatory interleukin-17
Change in interleukin-17 serum concentration assessed by ELISA
Time frame: 12 months after delivery compared to baseline
Anti-inflammatory interleukin-10
Change in anti-inflammatory interleukin-10 serum concentration assessed by ELISA
Time frame: 12 months after delivery compared to baseline
Autoantibody profiling
Identification and quantification of autoantibodies by using protein microarray and ELISA
Time frame: 12 months after delivery compared to baseline
Fecal microbiome composition
Composition of fecal microbiome measured by 16S Sequencing
Time frame: 12 months after delivery compared to baseline
Thickness of the retinal nerve fibre layer
Thickness of the retinal nerve fibre layer by Optical Coherence Tomography (OCT)
Time frame: 12 months after delivery (compared to baseline)
Total macular volume (TMV)
Total macular volume by Optical Coherence Tomography (OCT)
Time frame: 12 months after delivery compared to baseline
Mini-International Neuropsychiatric Interview (M.I.N.I.) German Version 5.0.0 Module A-C
Structured diagnostic interview to assess depression, dysthymia and suicidality
Time frame: 12 months after delivery compared to baseline
Montgomery-Asberg Depression Rating Scale (MADRS)
Rating of ten depression related symptoms on a scale from 0 to 6 (higher numbers indicate more severe symptoms)
Time frame: 12 months after delivery compared to baseline
Beck Depression Inventory (BDI-II)
Rating of 21 depression related symptoms on a scale from 0 to 3 (higher numbers indicate more severe symptoms)
Time frame: 12 months after delivery compared to baseline
Edinburgh Postpartum Depression Scale (EPDS)
Self-report survey containing 10 items, each item is rated 0-3 (higher scores indicate a higher probability of postpartum depression)
Time frame: 12 months after delivery compared to baseline
Modified Fatigue Inventory Scale (MFIS)
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)
Time frame: 12 months after delivery compared to baseline
Fatigue Severity Scale (FSS)
A self-report survey consisting of 11 items, each item ranges from 1 to 7 (higher scores indicate higher levels of fatigue)
Time frame: 12 months after delivery compared to baseline
Visual Fatigue Analogue Scale (VFAS)
A self-administered, single scale indication measuring visual fatigue, ranging from 0 to 100 (higher scores indicate worse fatigue)
Time frame: 12 months after delivery compared to baseline
Short-Form Health Survey (SF-36)
A self-report survey measuring health in eight dimensions (higher scores indicate less disability)
Time frame: 12 months after delivery compared to baseline