Pregnancy Cohort in Multiple Sclerosis (MS)

Recruiting

• Conditions: Multiple Sclerosis (MS); Clinically Isolated Syndrome (CIS)

• Registration Number: NCT05010902
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time until relapse	12 months after delivery compared to baseline	Time (in days) until relapse during the observation period

Secondary Outcome Measures

Name	Time	Method
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)
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)
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
Pro-inflammatory interleukin-17	12 months after delivery compared to baseline	Change in interleukin-17 serum concentration assessed by ELISA
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)
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)
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)
Anti-inflammatory interleukin-10	12 months after delivery compared to baseline	Change in anti-inflammatory interleukin-10 serum concentration assessed by ELISA
Number of T2 lesions	12 months after delivery compared to baseline	Number of T2 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
Change in immune cell phenotypes	12 months after delivery compared to baseline	Change in immune cell phenotypes of peripheral blood mononuclear cells (PBMC)
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
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
Volume of gadolinium enhancing lesions	12 months after delivery compared to baseline	Volume of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
Neurofilament (NfL)	12 months after delivery compared to baseline	Change in neurofilament serum concentration by using Simoa NfL assay
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)
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)
Number of gadolinium enhancing lesions	12 months after delivery compared to baseline	Number of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
Galectin-9	12 months after delivery compared to baseline	Change in serum galectin-9 concentration measured by ELISA

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany