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PREG-MS: New England MS Pregnancy Registry

PREG-MS: New England MS Pregnancy Prospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03368157
Enrollment
168
Registered
2017-12-11
Start date
2017-04-07
Completion date
2022-12-07
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Pregnancy Related

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.

Interventions

None listed

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
The relationship between EDSS and pregnancy course9 monthsThe investigators assessed the correlation between EDSS scores and the presence of pregnancy complications, or the lack thereof.

Secondary

MeasureTime frameDescription
The relationship between MS treatments and pregnancy course9 monthsThe investigators assessed the effects of Disease modifying therapies used to treat MS and its implication on the pregnancy course.

Other

MeasureTime frameDescription
The weight (pounds) of infants born to MS affected mothers3 yearsThe evaluation of the weight in pounds of infants born to mothers affected by MS compared to standard pediatric measurements.
The length (inches) of infants born to MS affected mothers3 yearsThe evaluation of the length in inches of infants born to mothers affected by MS compared to pediatric standard measurements.
The head circumference (inches) of infants born to MS affected mothers3 yearsThe evaluation of the head circumference in inches of infants born to mothers affected by MS compared to pediatric standard measurements.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026