Pregnancy Cohort in Multiple Sclerosis (MS)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Nadja Siebert, MD; Email: nadja.siebert@charite.de
• Study Contact Backup: Name: Friedemann Paul, Prof.; Email: friedemann.paul@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Recruiting
    • Charité Universitätsmedizin Berlin
    • Contact: Nadja Siebert, MD; Email: nadja.siebert@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruted at neurological outpatient clinics and neurological clinics of the Charité and neurologists' medical practices.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Multiple sclerosis; Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until relapse	Time (in days) until relapse during the observation period	12 months after delivery compared to baseline

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Nadja Siebert, MD, Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: PreCoMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No