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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple sclerosis | Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Time until relapse | Time (in days) until relapse during the observation period | 12 months after delivery compared to baseline |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruted at neurological outpatient clinics and neurological clinics of the Charité and neurologists' medical practices.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadja Siebert, MD | Contact | nadja.siebert@charite.de | ||
| Friedemann Paul, Prof. | Contact | friedemann.paul@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Nadja Siebert, MD | Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin | Recruiting | Berlin | 13125 | Germany |
Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification
Beginning 9 months and ending 36 months following article publication
Researchers who provide a methodologically sound proposal
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Stool and blood samples
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |