Pregnancy Cohort in Multiple Sclerosis (MS)

Charite University, Berlin, Germany1 site in 1 country100 target enrollmentJanuary 1, 2013

ConditionsMultiple Sclerosis (MS)Clinically Isolated Syndrome (CIS)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis (MS)
Sponsor: Charite University, Berlin, Germany
Enrollment: 100
Locations: 1
Primary Endpoint: Time until relapse
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2013

End Date

December 31, 2026

Last Updated

last year

Study Type

Observational

Sex

Female

Investigators

Sponsor

Charite University, Berlin, Germany

Responsible Party

Principal Investigator

Nadja Siebert

Principal Investigator

Charite University, Berlin, Germany

Eligibility 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

Outcomes

Primary Outcomes

Time until relapse

Time Frame: 12 months after delivery compared to baseline

Time (in days) until relapse during the observation period

Secondary Outcomes

Galectin-1(12 months after delivery compared to baseline)
Galectin-3(12 months after delivery compared to baseline)
Pro-inflammatory interleukin-17(12 months after delivery compared to baseline)
Montgomery-Asberg Depression Rating Scale (MADRS)(12 months after delivery compared to baseline)
Modified Fatigue Inventory Scale (MFIS)(12 months after delivery compared to baseline)
Visual Fatigue Analogue Scale (VFAS)(12 months after delivery compared to baseline)
Short-Form Health Survey (SF-36)(12 months after delivery compared to baseline)
Number of T2 lesions(12 months after delivery compared to baseline)
Volume of T2 lesions(12 months after delivery compared to baseline)
Anti-inflammatory interleukin-10(12 months after delivery compared to baseline)
Thickness of the retinal nerve fibre layer(12 months after delivery (compared to baseline))
Beck Depression Inventory (BDI-II)(12 months after delivery compared to baseline)
Change in immune cell phenotypes(12 months after delivery compared to baseline)
Autoantibody profiling(12 months after delivery compared to baseline)
Fecal microbiome composition(12 months after delivery compared to baseline)
Total macular volume (TMV)(12 months after delivery compared to baseline)
Mini-International Neuropsychiatric Interview (M.I.N.I.) German Version 5.0.0 Module A-C(12 months after delivery compared to baseline)
Volume of gadolinium enhancing lesions(12 months after delivery compared to baseline)
Neurofilament (NfL)(12 months after delivery compared to baseline)
Edinburgh Postpartum Depression Scale (EPDS)(12 months after delivery compared to baseline)
Fatigue Severity Scale (FSS)(12 months after delivery compared to baseline)
Number of gadolinium enhancing lesions(12 months after delivery compared to baseline)
Galectin-9(12 months after delivery compared to baseline)