PREG-MS: New England MS Pregnancy Registry

NCT03368157 | Completed

• 1 other identifier: 2016P000588
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (1)

• The relationship between MS treatments and pregnancy course

  9 months

Other Outcomes (3)

• The weight (pounds) of infants born to MS affected mothers

  3 years

• The length (inches) of infants born to MS affected mothers

  3 years

• The head circumference (inches) of infants born to MS affected mothers

  3 years

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 39810912 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 11, 2017
• Study Start: April 7, 2017
• Primary Completion: July 7, 2022
• Study Completion: December 7, 2022
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)