Pregnancy Cohort in Multiple Sclerosis (MS)

Multiple Sclerosis (MS) Clinical Trial

Official title:

Pregnancy Cohort in Multiple Sclerosis (MS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05010902
• Other study ID #: PreCoMS
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Nadja Siebert, MD
• Email: nadja.siebert[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinically Isolated Syndrome (CIS)
• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Sclerosis

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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