Pregnancy Cohort in Multiple Sclerosis (MS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorCharite University, Berlin, Germany
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age > 18 years
signed informed consent
diagnosis of multiple sclerosis or clinically isolated syndrome
Disqualifiers
clinically relevant comorbidities
contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
alcohol or drug abuse
Trial population
Patients will be recruted at neurological outpatient clinics and neurological clinics of the Charité and neurologists' medical practices.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Multiple sclerosis
Trial outcomes
Primary outcomes
1
Time until relapse
Time (in days) until relapse during the observation period
Time frame
12 months after delivery compared to baselineSecondary outcomes
1
Number of T2 lesions
Number of T2 lesions in spinal and cerebral magnetic resonance imaging
Time frame
12 months after delivery compared to baseline2
Number of gadolinium enhancing lesions
Number of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
Time frame
12 months after delivery compared to baseline3
Volume of T2 lesions
Volume of T2 lesions in spinal and cerebral magnetic resonance imaging
Time frame
12 months after delivery compared to baseline4
Volume of gadolinium enhancing lesions
Volume of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
Time frame
12 months after delivery compared to baselineSponsors and contacts
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Source ClinicalTrials.gov