PREG-MS: New England MS Pregnancy Registry

Multiple Sclerosis Clinical Trial

Official title:

PREG-MS: New England MS Pregnancy Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03368157
• Other study ID #: 2016P000588
• Status: Recruiting
• Start date: April 7, 2017
• Est. completion date: December 7, 2022

Study information

• Verified date: October 2021
• Source: Brigham and Women's Hospital
• Contact: Maria K Houtchens, M.D.
• Phone: 6175256550
• Email: mhoutchens[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of Multiple Sclerosis;

• Pregnant or actively planning to become pregnant.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Multiple Sclerosis
• Pregnancy Related

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The weight (pounds) of infants born to MS affected mothers	The evaluation of the weight in pounds of infants born to mothers affected by MS compared to standard pediatric measurements.	3 years
Other	The length (inches) of infants born to MS affected mothers	The evaluation of the length in inches of infants born to mothers affected by MS compared to pediatric standard measurements.	3 years
Other	The head circumference (inches) of infants born to MS affected mothers	The evaluation of the head circumference in inches of infants born to mothers affected by MS compared to pediatric standard measurements.	3 years
Primary	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	The relationship between MS treatments and pregnancy course	The investigators assessed the effects of Disease modifying therapies used to treat MS and its implication on the pregnancy course.	9 months