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Completed

NCT Number: NCT03368157

PREG-MS: New England MS Pregnancy Registry

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Pregnancy Related

Sex eligibility

Female

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

PREG-MS: New England MS Pregnancy Prospective Cohort Study

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2017
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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