Pregnancy Cohort in Multiple Sclerosis (MS)

July 3, 2024 updated by: Nadja Siebert, Charite University, Berlin, Germany
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Multiple sclerosis
Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time until relapse
Time Frame: 12 months after delivery compared to baseline
Time (in days) until relapse during the observation period
12 months after delivery compared to baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of T2 lesions
Time Frame: 12 months after delivery compared to baseline
Number of T2 lesions in spinal and cerebral magnetic resonance imaging
12 months after delivery compared to baseline
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
12 months after delivery compared to baseline
Volume of T2 lesions
Time Frame: 12 months after delivery compared to baseline
Volume of T2 lesions in spinal and cerebral magnetic resonance imaging
12 months after delivery compared to baseline
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
12 months after delivery compared to baseline
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)
12 months after delivery compared to baseline
Galectin-1
Time Frame: 12 months after delivery compared to baseline
Change in serum galectin-1 concentration measured by ELISA
12 months after delivery compared to baseline
Galectin-3
Time Frame: 12 months after delivery compared to baseline
Change in serum galectin-3 concentration measured by ELISA
12 months after delivery compared to baseline
Galectin-9
Time Frame: 12 months after delivery compared to baseline
Change in serum galectin-9 concentration measured by ELISA
12 months after delivery compared to baseline
Neurofilament (NfL)
Time Frame: 12 months after delivery compared to baseline
Change in neurofilament serum concentration by using Simoa NfL assay
12 months after delivery compared to baseline
Pro-inflammatory interleukin-17
Time Frame: 12 months after delivery compared to baseline
Change in interleukin-17 serum concentration assessed by ELISA
12 months after delivery compared to baseline
Anti-inflammatory interleukin-10
Time Frame: 12 months after delivery compared to baseline
Change in anti-inflammatory interleukin-10 serum concentration assessed by ELISA
12 months after delivery compared to baseline
Autoantibody profiling
Time Frame: 12 months after delivery compared to baseline
Identification and quantification of autoantibodies by using protein microarray and ELISA
12 months after delivery compared to baseline
Fecal microbiome composition
Time Frame: 12 months after delivery compared to baseline
Composition of fecal microbiome measured by 16S Sequencing
12 months after delivery compared to baseline
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)
12 months after delivery (compared to baseline)
Total macular volume (TMV)
Time Frame: 12 months after delivery compared to baseline
Total macular volume by Optical Coherence Tomography (OCT)
12 months after delivery compared to baseline
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
12 months after delivery compared to baseline
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)
12 months after delivery compared to baseline
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)
12 months after delivery compared to baseline
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)
12 months after delivery compared to baseline
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)
12 months after delivery compared to baseline
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)
12 months after delivery compared to baseline
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)
12 months after delivery compared to baseline
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)
12 months after delivery compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nadja Siebert, MD, Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PreCoMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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