Clinical trial NCT05010902: Pregnancy Cohort in Multiple Sclerosis (MS)
Official title: Pregnancy Cohort in Multiple Sclerosis (MS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis (MS)
Clinically Isolated Syndrome (CIS)
Keywords: Pregnancy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Time until relapse
timeFrame: 12 months after delivery compared to baseline
Secondary outcomes:
measure: Number of T2 lesions
timeFrame: 12 months after delivery compared to baseline
measure: Number of gadolinium enhancing lesions
timeFrame: 12 months after delivery compared to baseline
measure: Volume of T2 lesions
timeFrame: 12 months after delivery compared to baseline
measure: Volume of gadolinium enhancing lesions
timeFrame: 12 months after delivery compared to baseline
measure: Change in immune cell phenotypes
timeFrame: 12 months after delivery compared to baseline
measure: Galectin-1
timeFrame: 12 months after delivery compared to baseline
measure: Galectin-3
timeFrame: 12 months after delivery compared to baseline
measure: Galectin-9
timeFrame: 12 months after delivery compared to baseline
measure: Neurofilament (NfL)
timeFrame: 12 months after delivery compared to baseline
measure: Pro-inflammatory interleukin-17
timeFrame: 12 months after delivery compared to baseline
measure: Anti-inflammatory interleukin-10
timeFrame: 12 months after delivery compared to baseline
measure: Autoantibody profiling
timeFrame: 12 months after delivery compared to baseline
measure: Fecal microbiome composition
timeFrame: 12 months after delivery compared to baseline
measure: Thickness of the retinal nerve fibre layer
timeFrame: 12 months after delivery (compared to baseline)
measure: Total macular volume (TMV)
timeFrame: 12 months after delivery compared to baseline
measure: Mini-International Neuropsychiatric Interview (M.I.N.I.) German Version 5.0.0 Module A-C
timeFrame: 12 months after delivery compared to baseline
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 12 months after delivery compared to baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: 12 months after delivery compared to baseline
measure: Edinburgh Postpartum Depression Scale (EPDS)
timeFrame: 12 months after delivery compared to baseline
measure: Modified Fatigue Inventory Scale (MFIS)
timeFrame: 12 months after delivery compared to baseline
measure: Fatigue Severity Scale (FSS)
timeFrame: 12 months after delivery compared to baseline
measure: Visual Fatigue Analogue Scale (VFAS)
timeFrame: 12 months after delivery compared to baseline
measure: Short-Form Health Survey (SF-36)
timeFrame: 12 months after delivery compared to baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin
name: Nadja Siebert, MD
role: PRINCIPAL_INVESTIGATOR
References: