PREG-MS: New England MS Pregnancy Registry
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Other Outcome Measures
- The weight (pounds) of infants born to MS affected mothers [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 [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 [3 years]
The evaluation of the head circumference in inches of infants born to mothers affected by MS compared to pediatric standard measurements.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Multiple Sclerosis;
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Pregnant or actively planning to become pregnant.
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Brigham and Women's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016P000588