PREG-MS: New England MS Pregnancy Registry

November 21, 2025 updated by: Maria Houtchens, Brigham and Women's Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

168

Contacts and Locations

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

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women who are pregnant or are actively trying to become pregnant.

Description

Inclusion Criteria:

  • Diagnosis of Multiple Sclerosis;
  • Pregnant or actively planning to become pregnant.

Exclusion Criteria:

-

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between MS treatments and pregnancy course
Time Frame: 9 months
The investigators assessed the effects of Disease modifying therapies used to treat MS and its implication on the pregnancy course.
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The weight (pounds) of infants born to MS affected mothers
Time Frame: 3 years
The evaluation of the weight in pounds of infants born to mothers affected by MS compared to standard pediatric measurements.
3 years
The length (inches) of infants born to MS affected mothers
Time Frame: 3 years
The evaluation of the length in inches of infants born to mothers affected by MS compared to pediatric standard measurements.
3 years
The head circumference (inches) of infants born to MS affected mothers
Time Frame: 3 years
The evaluation of the head circumference in inches of infants born to mothers affected by MS compared to pediatric standard measurements.
3 years

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 7, 2017

Primary Completion (Actual)

July 7, 2022

Study Completion (Actual)

December 7, 2022

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P000588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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