Pregnancy Cohort in Multiple Sclerosis (MS)

NCT05010902 | Recruiting

• 1 other identifier: PreCoMS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Time until relapse

  Time (in days) until relapse during the observation period

  12 months after delivery compared to baseline

Secondary Outcomes (23)

• Number of T2 lesions

  12 months after delivery compared to baseline

• Number of gadolinium enhancing lesions

  12 months after delivery compared to baseline

• Volume of T2 lesions

  12 months after delivery compared to baseline

• Volume of gadolinium enhancing lesions

  12 months after delivery compared to baseline

• Change in immune cell phenotypes

  12 months after delivery compared to baseline

Study Arms (1)

Multiple sclerosis

Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• age \> 18 years
• signed informed consent
• diagnosis of multiple sclerosis or clinically isolated syndrome

You may not qualify if:

• clinically relevant comorbidities
• contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
• alcohol or drug abuse

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 13125, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool and blood samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nadja Siebert, MD

  Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadja Siebert, MD

CONTACT

nadja.siebert@charite.de

Friedemann Paul, Prof.

CONTACT

friedemann.paul@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 18, 2021
• Study Start: January 1, 2013
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

DE (1)