PRISMA: Pregnancy Registry for Chronic Neurological Conditions
This study, called PRISMA, is a registry collecting information about pregnancy in women with chronic neurological conditions like Multiple Sclerosis (MS), Clinically Isolated Syndrome (CIS), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myasthenia Gravis. The study aims to understand how these conditions and their treatments affect mothers during pregnancy and for 12 months postpartum. Researchers will look at your disease activity (how active your condition is) using a scale called EDSS and MRI scans, as well as the disease-modifying therapies (DMTs) you use. You may be eligible if you are a woman aged 18-64, are pregnant or planning to be, and have one of the listed conditions. The study is currently unclear on its recruitment status and plans to enroll 250 participants.
- Study design
- This is an observational study, meaning researchers will collect information without providing any specific treatments. It aims to enroll 250 participants.
- What's involved
- You may be asked to provide blood, breast milk, infant stool, maternal stool, and vaginal swab samples, and complete online surveys at specific times. All study activities will be discussed upon enrollment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your disease activity and treatment course will be followed from pre-pregnancy (if applicable) through 12 months postpartum.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Riley Bove, MD, MSc · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Maternal Disease Activity During Pregnancy and Postpartum Assessed by Expanded Disability Status Scale (EDSS)From pre-pregnancy (if applicable) through 12 months postpartum
Changes in maternal disease activity will be assessed using the Expanded Disability Status Scale (EDSS) for individuals with multiple sclerosis (scored from 0 to 10, with higher scores indicating greater disability). Data will be collected via medical record review and participant self-report questionnaires.
- Maternal Disease Activity During Pregnancy and Postpartum Assessed by MRI FindingsFrom pre-pregnancy (if applicable) through 12 months postpartum
Changes in maternal disease activity will be assessed using magnetic resonance imaging (MRI) findings, including gadolinium-enhancing lesions, new or enlarging T2 lesions, and brain atrophy. Data will be collected via medical record review.
- Maternal Disease Treatment Course During Pregnancy and Postpartum Assessed by Disease Modifying Therapy (DMT) UseFrom pre-pregnancy (if applicable) through 12 months postpartum
The maternal disease treatment course will be evaluated through an assessment of Disease Modifying Therapy (DMT) used pre-pregnancy to postpartum. This includes the specific type of DMT used in the pre-pregnancy period, any modifications or discontinuation of therapy during pregnancy, and the resumption or initiation of DMTs in the postpartum period. Data will be obtained through medical record review.
- Maternal Disease Activity During Pregnancy and Postpartum Assessed by Clinical Relapse RatesFrom pre-pregnancy (if applicable) through 12 months postpartum
Changes in maternal disease activity will be assessed using the clinical relapse rate. Relapses will be identified based on medical record review and participant self-report questionnaires administered at regular intervals. Additional information, such as the timing, severity, and treatment of relapses, will be collected when available.