Multiple SclerosisNCT03368157
PREG-MS: New England MS Pregnancy Registry
An observational study of Multiple Sclerosis and Pregnancy Related, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of the study is to develop a detailed pregnancy registry of patients with Multiple Sclerosis in the New England states. Women with a diagnosis of MS that are either pregnant or actively planning to become pregnant are eligible to participate. The study will solely take place through phone interviews. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Multiple Sclerosis, Pregnancy Related
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 7 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who are pregnant or are actively trying to become pregnant.
Who may be able to join
- Diagnosis of Multiple Sclerosis;
- Pregnant or actively planning to become pregnant.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: PREG-MS: New England MS Pregnancy Prospective Cohort Study
The purpose of the study is to develop a detailed pregnancy registry of patients with Multiple Sclerosis in the New England states. Women with a diagnosis of MS that are either pregnant or actively planning to become pregnant are eligible to participate.
The study will solely take place through phone interviews. One of the study coordinator at the Partners MS Center will contact the participant for an intake phone interview where general information about the individual, their pregnancy and their MS will be collected. Thereafter the coordinator will contact the participant every 3 months for 20 minutes follow up interviews. After birth, the coordinator will collect information on the growth and development of the participant's baby. Pediatric interviews will be conducted at 2, 4, 6, 9, 12, 18, 24, 36 months. Information from the participant's neurologist and obstetrician, as well as information from the baby's pediatrician, will be made available to the study staff at regular intervals throughout the duration of the study.
Through this study, the investigators hope to learn more about the effects of MS on pregnancy and pediatric development, and about the effects of pregnancy on the course of MS.
- Conditions
- Multiple Sclerosis, Pregnancy Related
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between EDSS and pregnancy course
The investigators assessed the correlation between EDSS scores and the presence of pregnancy complications, or the lack thereof.
Measured: 9 months
Secondary outcomes (1)
The relationship between MS treatments and pregnancy course
The investigators assessed the effects of Disease modifying therapies used to treat MS and its implication on the pregnancy course.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start7 Apr 2017
- Primary completion7 Jul 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Houtchens, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368157
- Sponsor's protocol ID
- 2016P000588
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2017
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Houtchens MK, Manieri MC, Mahlanza TD, Pol-Patil J, Klawiter EC, Solomon AJ, Lathi E, Katz J, Ionete C, Morales IB, Severson C, Zurawski J, Stankiewicz JM, Cabot A, Sadovnick AD. A Real-World Prospective Multiple Sclerosis Pregnancy Registry in the United States: PREG-MS. Neurol Clin Pract. 2025 Apr;15(2):e200425. doi: 10.1212/CPJ.0000000000200425. Epub 2025 Jan 10.
PubMed 39810912
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREG-MS: New England MS Pregnancy Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03368157
- Acronym / sponsor ID
- 2016P000588
- Conditions
- Multiple Sclerosis, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 11 Dec 2017 (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.
The purpose of the study is to develop a detailed pregnancy registry of patients with Multiple Sclerosis in the New England states. Women with a diagnosis of MS that are either pregnant or actively planning to become pregnant are eligible to participate.
The study will solely take place through phone interviews. One of the study coordinator at the Partners MS Center will contact the participant for an intake phone interview where general information about the individual, their pregnancy and their MS will be collected. Thereafter the coordinator will contact the participant every 3 months for 20 minutes follow up interviews. After birth, the coordinator will collect information on the growth and development of the participant's baby. Pediatric interviews will be conducted at 2, 4, 6, 9, 12, 18, 24, 36 months. Information from the participant's neurologist and obstetrician, as well as information from the baby's pediatrician, will be made available to the study staff at regular intervals throughout the duration of the study.
Through this study, the investigators hope to learn more about the effects of MS on pregnancy and pediatric development, and about the effects of pregnancy on the course of MS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who are pregnant or are actively trying to become pregnant.
Key inclusion criteria (2 listed)
- Diagnosis of Multiple Sclerosis;
- Pregnant or actively planning to become pregnant.
Key exclusion criteria (1 listed)
- -
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
The relationship between EDSS and pregnancy course
Time frame: 9 months
The investigators assessed the correlation between EDSS scores and the presence of pregnancy complications, or the lack thereof.
1 secondary outcome
The relationship between MS treatments and pregnancy course
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 39810912Houtchens MK, Manieri MC, Mahlanza TD, Pol-Patil J, Klawiter EC, Solomon AJ, Lathi E, Katz J, Ionete C, Morales IB, Severson C, Zurawski J, Stankiewicz JM, Cabot A, Sadovnick AD. A Real-World Prospective Multiple Sclerosis Pregnancy Registry in the United States: PREG-MS. Neurol Clin Pract. 2025 Apr;15(2):e200425. doi: 10.1212/CPJ.0000000000200425. Epub 2025 Jan 10.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Pregnancy Related, run by Brigham and Women's Hospital at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Nov 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between EDSS and pregnancy course (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03368157, which also lists 1 linked publication.
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 24 Nov 2025.