Actively Recruiting
Pregnancy Cohort in Multiple Sclerosis (MS)
Led by Charite University, Berlin, Germany · Updated on 2024-07-05
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on women with multiple sclerosis (MS) or clinically isolated syndrome who are in their reproductive years. The study observes the outcomes of pregnancies in women affected by MS and examines how pregnancy impacts clinical symptoms, laboratory results, and MRI findings related to MS. The study is observational and aims to collect detailed data to better understand these changes. Participants include women diagnosed with clinically isolated syndrome, relapsing-remitting, or progressive multiple sclerosis. The study does not involve specific treatments but collects information over time to observe natural disease progression and pregnancy effects. Data will be collected before and up to 12 months after delivery to compare disease activity and other measures. During the study, participants undergo clinical evaluations, laboratory tests, and MRI scans to monitor disease status and pregnancy effects. Various biological markers, immune cell profiles, and brain imaging results will be compared between baseline and 12 months postpartum. Mental health and fatigue assessments are also included. The primary outcome is the time until relapse within 12 months after delivery compared to before pregnancy. Participants will be closely followed for the duration of pregnancy and one year after giving birth.
CONDITIONS
Brief Title
Pregnancy Cohort in Multiple Sclerosis (MS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Signed informed consent
- Diagnosis of multiple sclerosis or clinically isolated syndrome
You will not qualify if you...
- Clinically relevant comorbidities
- Contraindications for MRI, such as pacemaker, metal implants, or allergy to gadolinium
- Alcohol or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 months after delivery
Participants with multiple sclerosis are observed over time to compare health measures 12 months after delivery to baseline.
Visits scheduled to collect clinical and imaging data before pregnancy, at delivery, and 12 months postpartum
Trial Site Locations
Total: 1 location
1
Charité Universitätsmedizin Berlin
Berlin, Germany, 13125
Actively Recruiting
Research Team
N
Nadja Siebert, MD
F
Friedemann Paul, Prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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