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 : January 15, 2019
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|
|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|
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Maria K Houtchensemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Maria Claudia Manieri, BA 857-307-2546 firstname.lastname@example.org|