Pregnancy Cohort in Multiple Sclerosis (MS)
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Multiple sclerosis Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis |
Outcome Measures
Primary Outcome Measures
- Time until relapse [12 months after delivery compared to baseline]
Time (in days) until relapse during the observation period
Secondary Outcome Measures
- Number of T2 lesions [12 months after delivery compared to baseline]
Number of T2 lesions in spinal and cerebral magnetic resonance imaging
- Number of gadolinium enhancing lesions [12 months after delivery compared to baseline]
Number of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
- Volume of T2 lesions [12 months after delivery compared to baseline]
Volume of T2 lesions in spinal and cerebral magnetic resonance imaging
- Volume of gadolinium enhancing lesions [12 months after delivery compared to baseline]
Volume of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
- Change in immune cell phenotypes [12 months after delivery compared to baseline]
Change in immune cell phenotypes of peripheral blood mononuclear cells (PBMC)
- Galectin-1 [12 months after delivery compared to baseline]
Change in serum galectin-1 concentration measured by ELISA
- Galectin-3 [12 months after delivery compared to baseline]
Change in serum galectin-3 concentration measured by ELISA
- Galectin-9 [12 months after delivery compared to baseline]
Change in serum galectin-9 concentration measured by ELISA
- Neurofilament (NfL) [12 months after delivery compared to baseline]
Change in neurofilament serum concentration by using Simoa NfL assay
- Pro-inflammatory interleukin-17 [12 months after delivery compared to baseline]
Change in interleukin-17 serum concentration assessed by ELISA
- Anti-inflammatory interleukin-10 [12 months after delivery compared to baseline]
Change in anti-inflammatory interleukin-10 serum concentration assessed by ELISA
- Autoantibody profiling [12 months after delivery compared to baseline]
Identification and quantification of autoantibodies by using protein microarray and ELISA
- Fecal microbiome composition [12 months after delivery compared to baseline]
Composition of fecal microbiome measured by 16S Sequencing
- Thickness of the retinal nerve fibre layer [12 months after delivery (compared to baseline)]
Thickness of the retinal nerve fibre layer by Optical Coherence Tomography (OCT)
- Total macular volume (TMV) [12 months after delivery compared to baseline]
Total macular volume by Optical Coherence Tomography (OCT)
- Mini-International Neuropsychiatric Interview (M.I.N.I.) German Version 5.0.0 Module A-C [12 months after delivery compared to baseline]
Structured diagnostic interview to assess depression, dysthymia and suicidality
- Montgomery-Asberg Depression Rating Scale (MADRS) [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)
- Beck Depression Inventory (BDI-II) [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)
- Edinburgh Postpartum Depression Scale (EPDS) [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)
- Modified Fatigue Inventory Scale (MFIS) [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)
- Fatigue Severity Scale (FSS) [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)
- Visual Fatigue Analogue Scale (VFAS) [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)
- Short-Form Health Survey (SF-36) [12 months after delivery compared to baseline]
A self-report survey measuring health in eight dimensions (higher scores indicate less disability)
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charité Universitätsmedizin Berlin | Berlin | Germany | 13125 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Principal Investigator: Anja Mähler, PhD, Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PreCoMS