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Pregnancy Cohort in Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT05010902
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Anja Maehler, Charite University, Berlin, Germany

Tracking Information
First Submitted Date July 21, 2021
First Posted Date August 18, 2021
Last Update Posted Date February 7, 2024
Actual Study Start Date January 1, 2013
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2021)		 Time until relapse [ Time Frame: 12 months after delivery compared to baseline ]
Time (in days) until relapse during the observation period
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 17, 2021)
  • Number of T2 lesions [ Time Frame: 12 months after delivery compared to baseline ]
    Number of T2 lesions in spinal and cerebral magnetic resonance imaging
  • Number of gadolinium enhancing lesions [ Time Frame: 12 months after delivery compared to baseline ]
    Number of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
  • Volume of T2 lesions [ Time Frame: 12 months after delivery compared to baseline ]
    Volume of T2 lesions in spinal and cerebral magnetic resonance imaging
  • Volume of gadolinium enhancing lesions [ Time Frame: 12 months after delivery compared to baseline ]
    Volume of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
  • Change in immune cell phenotypes [ Time Frame: 12 months after delivery compared to baseline ]
    Change in immune cell phenotypes of peripheral blood mononuclear cells (PBMC)
  • Galectin-1 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in serum galectin-1 concentration measured by ELISA
  • Galectin-3 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in serum galectin-3 concentration measured by ELISA
  • Galectin-9 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in serum galectin-9 concentration measured by ELISA
  • Neurofilament (NfL) [ Time Frame: 12 months after delivery compared to baseline ]
    Change in neurofilament serum concentration by using Simoa NfL assay
  • Pro-inflammatory interleukin-17 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in interleukin-17 serum concentration assessed by ELISA
  • Anti-inflammatory interleukin-10 [ Time Frame: 12 months after delivery compared to baseline ]
    Change in anti-inflammatory interleukin-10 serum concentration assessed by ELISA
  • Autoantibody profiling [ Time Frame: 12 months after delivery compared to baseline ]
    Identification and quantification of autoantibodies by using protein microarray and ELISA
  • Fecal microbiome composition [ Time Frame: 12 months after delivery compared to baseline ]
    Composition of fecal microbiome measured by 16S Sequencing
  • Thickness of the retinal nerve fibre layer [ Time Frame: 12 months after delivery (compared to baseline) ]
    Thickness of the retinal nerve fibre layer by Optical Coherence Tomography (OCT)
  • Total macular volume (TMV) [ Time Frame: 12 months after delivery compared to baseline ]
    Total macular volume by Optical Coherence Tomography (OCT)
  • Mini-International Neuropsychiatric Interview (M.I.N.I.) German Version 5.0.0 Module A-C [ Time Frame: 12 months after delivery compared to baseline ]
    Structured diagnostic interview to assess depression, dysthymia and suicidality
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 months after delivery compared to baseline ]
    Rating of ten depression related symptoms on a scale from 0 to 6 (higher numbers indicate more severe symptoms)
  • Beck Depression Inventory (BDI-II) [ Time Frame: 12 months after delivery compared to baseline ]
    Rating of 21 depression related symptoms on a scale from 0 to 3 (higher numbers indicate more severe symptoms)
  • Edinburgh Postpartum Depression Scale (EPDS) [ Time Frame: 12 months after delivery compared to baseline ]
    Self-report survey containing 10 items, each item is rated 0-3 (higher scores indicate a higher probability of postpartum depression)
  • Modified Fatigue Inventory Scale (MFIS) [ Time Frame: 12 months after delivery compared to baseline ]
    Self-report survey containing 21 items, each item is rated 0-4 (higher scores indicate a greater impact of fatigue on a person's activities)
  • Fatigue Severity Scale (FSS) [ Time Frame: 12 months after delivery compared to baseline ]
    A self-report survey consisting of 11 items, each item ranges from 1 to 7 (higher scores indicate higher levels of fatigue)
  • Visual Fatigue Analogue Scale (VFAS) [ Time Frame: 12 months after delivery compared to baseline ]
    A self-administered, single scale indication measuring visual fatigue, ranging from 0 to 100 (higher scores indicate worse fatigue)
  • Short-Form Health Survey (SF-36) [ Time Frame: 12 months after delivery compared to baseline ]
    A self-report survey measuring health in eight dimensions (higher scores indicate less disability)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pregnancy Cohort in Multiple Sclerosis (MS)
Official Title Pregnancy Cohort in Multiple Sclerosis (MS)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Stool and blood samples
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.
Condition
  • Multiple Sclerosis (MS)
  • Clinically Isolated Syndrome (CIS)
Intervention Not Provided
Study Groups/Cohorts Multiple sclerosis
Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 17, 2021)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2026
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Nadja Siebert, MD nadja.siebert@charite.de
Contact: Friedemann Paul, Prof. friedemann.paul@charite.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT05010902
Other Study ID Numbers PreCoMS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication
Access Criteria: Researchers who provide a methodologically sound proposal
Current Responsible Party Anja Maehler, Charite University, Berlin, Germany
Original Responsible Party Same as current
Current Study Sponsor Charite University, Berlin, Germany
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Anja Mähler, PhD Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin
PRS Account Charite University, Berlin, Germany
Verification Date February 2024