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PREG-MS: New England MS Pregnancy Registry

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ClinicalTrials.gov Identifier: NCT03368157
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Houtchens, 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.


Condition or disease
Multiple Sclerosis Pregnancy Related

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PREG-MS: New England MS Pregnancy Prospective Cohort Study
Actual Study Start Date : April 7, 2016
Estimated Primary Completion Date : April 7, 2019
Estimated Study Completion Date : April 7, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who are pregnant or are actively trying to become pregnant.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368157


Contacts
Contact: Maria K Houtchens mhoutchens@bwh.harvard.edu

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Tatenda Mahlanza, BA    617-732-5500    tmahlanza@bwh.harvard.edu   
Contact: Maria Manieri, BA    8573072546    mmanieri@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital

Responsible Party: Maria Houtchens, Assistant Professor of Neurology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03368157     History of Changes
Other Study ID Numbers: 2016P000588
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases