Clinical and Radiologic Disease Activity in Pregnancy and Postpartum in MS.
Annika Anderson, Kristen M Krysko, Alice Rutatangwa...
https://pubmed.ncbi.nlm.nih.gov/33608303/Actively Recruiting
Led by University of California, San Francisco · Updated on 2026-08-11
250
Participants Needed
1
Research Sites
260 weeks
Total Duration
Researchers are investigating pregnancy in women with chronic neurological and inflammatory conditions, including multiple sclerosis MS, clinically isolated syndrome CIS, neuromyelitis optica spectrum disorder NMOSD, inflammatory bowel disease IBD, rheumatoid arthritis RA, lupus, myasthenia gravis, and other related disorders. This observational study aims to better understand the relationship between these conditions, pregnancy, and maternal and infant health by collecting detailed clinical, survey, and biospecimen data. Participants include women who are planning pregnancy, currently pregnant, or within one year postpartum. The study collects various biospecimens such as blood, breast milk, infant stool, maternal stool, and vaginal swabs at multiple time points from pregnancy planning through up to 2-3 years postpartum. Some participants provide samples before and after treatment with monoclonal antibodies, while healthy controls provide samples at specific postpartum months. Online surveys and medical record reviews supplement biospecimen collection to assess maternal and infant health outcomes. Throughout the study, participants complete interviews, surveys, and questionnaires on maternal disease activity, depression, social support, fatigue, sleep, cognitive function, bonding, and infant development. Medical records are reviewed for maternal radiographic data and infant growth and immunization outcomes. Sample collections and surveys are scheduled at baseline, multiple gestational points, and postpartum intervals up to one year or longer, with some biospecimen collections extending to 2-3 years postpartum. This fully remote study offers home blood draws and optional sample participation to maximize convenience and flexibility.
CONDITIONS
Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA)
M
Min Ji Kim Kim, BA
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University of California, San Francisco
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 remote screening visit
Duration - From planning pregnancy through up to 3 years postpartum
Participants provide biosamples like blood, breast milk, stool, and vaginal swabs at specific times. They also complete surveys and questionnaires about maternal health, depression, fatigue, sleep, cognitive function, and infant development. Medical records are reviewed for maternal and infant health information.
Remote sample collections and online surveys at scheduled timepoints
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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Annika Anderson, Kristen M Krysko, Alice Rutatangwa...
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https://pubmed.ncbi.nlm.nih.gov/37675826/University of California, San Francisco
Lead Sponsor