PREG-MS: New England MS Pregnancy Registry

• Conditions: Pregnancy Related; Multiple Sclerosis

• Registration Number: NCT03368157
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-07
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-15
• Primary Completion: 2022-07-07
• Study Completion: 2022-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relationship between EDSS and pregnancy course	9 months	The investigators assessed the correlation between EDSS scores and the presence of pregnancy complications, or the lack thereof.

Secondary Outcome Measures

Name	Time	Method
The relationship between MS treatments and pregnancy course	9 months	The investigators assessed the effects of Disease modifying therapies used to treat MS and its implication on the pregnancy course.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States