Multiple Sclerosis (MS)NCT05010902
Pregnancy Cohort in Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis (MS), Clinically Isolated Syndrome (CIS)
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2013to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients will be recruted at neurological outpatient clinics and neurological clinics of the Charité and neurologists' medical practices.
Who may be able to join
- age > 18 years
- signed informed consent
- diagnosis of multiple sclerosis or clinically isolated syndrome
Who cannot join
- clinically relevant comorbidities
- contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
- alcohol or drug abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nadja Siebert, MD contact
Friedemann Paul, Prof. contact
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13125
Nadja Siebert, MD, nadja.siebert@charite.de
About this study
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.
- Keywords
- Pregnancy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis | Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until relapse
Time (in days) until relapse during the observation period
Measured: 12 months after delivery compared to baseline
Secondary outcomes (23)
Number of T2 lesions
Number of T2 lesions in spinal and cerebral magnetic resonance imaging
Measured: 12 months after delivery compared to baseline
Number of gadolinium enhancing lesions
Number of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
Measured: 12 months after delivery compared to baseline
Volume of T2 lesions
Volume of T2 lesions in spinal and cerebral magnetic resonance imaging
Measured: 12 months after delivery compared to baseline
Volume of gadolinium enhancing lesions
Volume of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging
Measured: 12 months after delivery compared to baseline
Change in immune cell phenotypes
Change in immune cell phenotypes of peripheral blood mononuclear cells (PBMC)
Measured: 12 months after delivery compared to baseline
Galectin-1
Change in serum galectin-1 concentration measured by ELISA
Measured: 12 months after delivery compared to baseline
Galectin-3
Change in serum galectin-3 concentration measured by ELISA
Measured: 12 months after delivery compared to baseline
Galectin-9
Change in serum galectin-9 concentration measured by ELISA
Measured: 12 months after delivery compared to baseline
Neurofilament (NfL)
Change in neurofilament serum concentration by using Simoa NfL assay
Measured: 12 months after delivery compared to baseline
Pro-inflammatory interleukin-17
Change in interleukin-17 serum concentration assessed by ELISA
Measured: 12 months after delivery compared to baseline
Anti-inflammatory interleukin-10
Change in anti-inflammatory interleukin-10 serum concentration assessed by ELISA
Measured: 12 months after delivery compared to baseline
Autoantibody profiling
Identification and quantification of autoantibodies by using protein microarray and ELISA
Measured: 12 months after delivery compared to baseline
Fecal microbiome composition
Composition of fecal microbiome measured by 16S Sequencing
Measured: 12 months after delivery compared to baseline
Thickness of the retinal nerve fibre layer
Thickness of the retinal nerve fibre layer by Optical Coherence Tomography (OCT)
Measured: 12 months after delivery (compared to baseline)
Total macular volume (TMV)
Total macular volume by Optical Coherence Tomography (OCT)
Measured: 12 months after delivery compared to baseline
Mini-International Neuropsychiatric Interview (M.I.N.I.) German Version 5.0.0 Module A-C
Structured diagnostic interview to assess depression, dysthymia and suicidality
Measured: 12 months after delivery compared to baseline
Montgomery-Asberg Depression Rating Scale (MADRS)
Rating of ten depression related symptoms on a scale from 0 to 6 (higher numbers indicate more severe symptoms)
Measured: 12 months after delivery compared to baseline
Beck Depression Inventory (BDI-II)
Rating of 21 depression related symptoms on a scale from 0 to 3 (higher numbers indicate more severe symptoms)
Measured: 12 months after delivery compared to baseline
Edinburgh Postpartum Depression Scale (EPDS)
Self-report survey containing 10 items, each item is rated 0-3 (higher scores indicate a higher probability of postpartum depression)
Measured: 12 months after delivery compared to baseline
Modified Fatigue Inventory Scale (MFIS)
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)
Measured: 12 months after delivery compared to baseline
Fatigue Severity Scale (FSS)
A self-report survey consisting of 11 items, each item ranges from 1 to 7 (higher scores indicate higher levels of fatigue)
Measured: 12 months after delivery compared to baseline
Visual Fatigue Analogue Scale (VFAS)
A self-administered, single scale indication measuring visual fatigue, ranging from 0 to 100 (higher scores indicate worse fatigue)
Measured: 12 months after delivery compared to baseline
Short-Form Health Survey (SF-36)
A self-report survey measuring health in eight dimensions (higher scores indicate less disability)
Measured: 12 months after delivery compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Jan 2013
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadja Siebert, Charite University, Berlin, Germany
- Investigators
- Nadja Siebert, MD, Principal investigator, Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010902
- Sponsor's protocol ID
- PreCoMS
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2021
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Cohort in Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT05010902
- Acronym / sponsor ID
- PreCoMS
- Keywords
- Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis | – | –Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be recruted at neurological outpatient clinics and neurological clinics of the Charité and neurologists' medical practices.
Key inclusion criteria (3 listed)
- age > 18 years
- signed informed consent
- diagnosis of multiple sclerosis or clinically isolated syndrome
Key exclusion criteria (3 listed)
- clinically relevant comorbidities
- contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
- alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time until relapse
Time frame: 12 months after delivery compared to baseline
Time (in days) until relapse during the observation period
23 secondary outcomes
Number of T2 lesions
Time frame: 12 months after delivery compared to baseline
Number of gadolinium enhancing lesions
Time frame: 12 months after delivery compared to baseline
Volume of T2 lesions
Time frame: 12 months after delivery compared to baseline
Volume of gadolinium enhancing lesions
Time frame: 12 months after delivery compared to baseline
Change in immune cell phenotypes
Time frame: 12 months after delivery compared to baseline
Galectin-1
Time frame: 12 months after delivery compared to baseline
Galectin-3
Time frame: 12 months after delivery compared to baseline
Galectin-9
Time frame: 12 months after delivery compared to baseline
Neurofilament (NfL)
Time frame: 12 months after delivery compared to baseline
Pro-inflammatory interleukin-17
Time frame: 12 months after delivery compared to baseline
Anti-inflammatory interleukin-10
Time frame: 12 months after delivery compared to baseline
Autoantibody profiling
Time frame: 12 months after delivery compared to baseline
Fecal microbiome composition
Time frame: 12 months after delivery compared to baseline
Thickness of the retinal nerve fibre layer
Time frame: 12 months after delivery (compared to baseline)
Total macular volume (TMV)
Time frame: 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
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 12 months after delivery compared to baseline
Beck Depression Inventory (BDI-II)
Time frame: 12 months after delivery compared to baseline
Edinburgh Postpartum Depression Scale (EPDS)
Time frame: 12 months after delivery compared to baseline
Modified Fatigue Inventory Scale (MFIS)
Time frame: 12 months after delivery compared to baseline
Fatigue Severity Scale (FSS)
Time frame: 12 months after delivery compared to baseline
Visual Fatigue Analogue Scale (VFAS)
Time frame: 12 months after delivery compared to baseline
Short-Form Health Survey (SF-36)
Time frame: 12 months after delivery compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadja Siebert, MD contact
Friedemann Paul, Prof. contact
Nadja Siebert, MD principal investigator
Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS), run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadja Siebert, MD (nadja.siebert@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until relapse (time frame: 12 months after delivery compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.