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Clinical Trials/NCT03368157
NCT03368157
Completed
N/A

PREG-MS: New England MS Pregnancy Prospective Cohort Study

Brigham and Women's Hospital1 site in 1 country168 target enrollmentApril 7, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Brigham and Women's Hospital
Enrollment
168
Locations
1
Primary Endpoint
The relationship between EDSS and pregnancy course
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 7, 2017
End Date
December 7, 2022
Last Updated
5 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Houtchens

Assistant Professor of Neurology

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • The relationship between MS treatments and pregnancy course(9 months)

Study Sites (1)

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