Pregnancy registry for women with chronic neurological conditions
Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA): Pregnancy Registry for Women With Chronic Conditions
This study is collecting information and samples from pregnant women with chronic neurological conditions to see how pregnancy affects their health and their baby's development.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06940323 on ClinicalTrials.gov |
What this trial studies
PRISMA is an observational pregnancy registry that collects comprehensive information about pregnancy in women with chronic neurological conditions such as multiple sclerosis, clinically isolated syndrome, neuromyelitis optica spectrum disorder, and myasthenia gravis. Participants will provide biosamples, including blood, breast milk, and stool samples, at specific time points, along with completing online surveys. The study aims to develop a repository of samples to gain insights into the relationship between pregnancy, neurological conditions, and maternal and infant health. This includes monitoring maternal outcomes and infant development over time.
Who should consider this trial
Good fit: Ideal candidates include pregnant women or those contemplating pregnancy who have a diagnosis of multiple sclerosis, clinically isolated syndrome, neuromyelitis optica spectrum disorder, or other specified chronic conditions.
Not a fit: Patients who are unwilling to provide informed consent or do not have a chronic condition may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of pregnancy outcomes in women with chronic neurological conditions, potentially leading to improved maternal and infant health strategies.
How similar studies have performed: While there have been studies focusing on pregnancy outcomes in chronic conditions, this specific approach of creating a comprehensive pregnancy registry with biosample collection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant or contemplating pregnancy * Female, aged 18 to 64 years * Diagnosis of one of the following conditions: * Clinically Isolated Syndrome (CIS) or Multiple Sclerosis (MS), based on the 2010 McDonald Criteria * Neuromyelitis Optica Spectrum Disorder (NMOSD) * Inflammatory Bowel Disease (IBD) * Rheumatoid Arthritis (RA) * Myasthenia Gravis * Lupus * Other chronic neurological conditions * Willing to provide biosamples and/or complete surveys at specified timepoints * Women without a chronic condition who are pregnant or contemplating pregnancy (as part of the control group) Exclusion Criteria: \- Unwillingness to provide informed consent
Where this trial is running
San Francisco, California
- University of California-San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Riley Bove, MD, MSc — University of California, San Francisco
- Study coordinator: Min Ji Kim Kim, BA
- Email: minji.kim3@ucsf.edu
- Phone: 415-502-7209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.