Pregnancy Cohort in Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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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.

Official Title
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Pregnancy Cohort in Multiple Sclerosis (MS)

Conditions
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Multiple Sclerosis (MS), Clinically Isolated Syndrome (CIS)

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple sclerosis<br>Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until relapse | Time (in days) until relapse during the observation period | 12 months after delivery compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of T2 lesions | Number of T2 lesions in spinal and cerebral magnetic resonance imaging | 12 months after delivery compared to baseline | 
| Number of gadolinium enhancing lesions | Number of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging | 12 months after delivery compared to baseline | 
| Volume of T2 lesions | Volume of T2 lesions in spinal and cerebral magnetic resonance imaging | 12 months after delivery compared to baseline | 
| Volume of gadolinium enhancing lesions | Volume of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging | 12 months after delivery compared to baseline | 
| Change in immune cell phenotypes | Change in immune cell phenotypes of peripheral blood mononuclear cells (PBMC) | 12 months after delivery compared to baseline | 
| Galectin-1 | Change in serum galectin-1 concentration measured by ELISA | 12 months after delivery compared to baseline | 
| Galectin-3 | Change in serum galectin-3 concentration measured by ELISA | 12 months after delivery compared to baseline | 
| Galectin-9 | Change in serum galectin-9 concentration measured by ELISA | 12 months after delivery compared to baseline | 
| Neurofilament (NfL) | Change in neurofilament serum concentration by using Simoa NfL assay | 12 months after delivery compared to baseline | 
| Pro-inflammatory interleukin-17 | Change in interleukin-17 serum concentration assessed by ELISA | 12 months after delivery compared to baseline | 
| Anti-inflammatory interleukin-10 | Change in anti-inflammatory interleukin-10 serum concentration assessed by ELISA | 12 months after delivery compared to baseline | 
| Autoantibody profiling | Identification and quantification of autoantibodies by using protein microarray and ELISA | 12 months after delivery compared to baseline | 
| Fecal microbiome composition | Composition of fecal microbiome measured by 16S Sequencing | 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) | 12 months after delivery (compared to baseline) | 
| Total macular volume (TMV) | Total macular volume by Optical Coherence Tomography (OCT) | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 12 months after delivery compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy