Observing pregnancy outcomes in women with multiple sclerosis
Pregnancy Cohort in Multiple Sclerosis (MS)
This study looks at how pregnancy affects women with multiple sclerosis to see what happens to their health during this time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05010902 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women diagnosed with multiple sclerosis (MS) or clinically isolated syndrome (CIS) to gather data on pregnancy outcomes. It aims to assess how pregnancy affects clinical, laboratory, and MRI parameters in these patients. By monitoring these outcomes, the study seeks to provide insights into the relationship between pregnancy and MS. Participants will be followed throughout their pregnancies to collect comprehensive data.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old who have been diagnosed with multiple sclerosis or clinically isolated syndrome.
Not a fit: Patients with clinically relevant comorbidities or contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of pregnancy management in women with multiple sclerosis, potentially leading to better maternal and fetal health outcomes.
How similar studies have performed: While there have been studies on pregnancy in MS, this specific observational approach focusing on comprehensive data collection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Nadja Siebert, MD — Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin
- Study coordinator: Nadja Siebert, MD
- Email: nadja.siebert@charite.de
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.