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Observational Study of Pregnancy Outcomes and Disease Effects in Women Aged 18 to 50 with Multiple Sclerosis or Clinically Isolated Syndrome
Led by Charite University, Berlin, Germany · Updated on 2024-07-05
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
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)
Research Team
N
Nadja Siebert, MD
F
Friedemann Paul, Prof.
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