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NCT06940323Recruiting

Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA)

Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA): Pregnancy Registry for Women With Chronic Conditions

Source: ClinicalTrials.gov · Last updated 11 Aug 2026

Brief summary (registry, in English)

PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally. Depending on their specific condition (MS, CIS, NMOSD, or other) and their specific treatment, participants will be asked to contribute to different aspects of the study. (1) The biosamples will be blood, breast milk, infant stool, maternal stool and vaginal swab samples, collected at specific time points. (2) The online surveys will be collected at specific time points. All study activities will be discussed with participants upon enrollment. By collecting this information, the investigators hope to gain deeper insights into the relationship between pregnancy, the neurological condition, and maternal and infant health. For example, one of the sub-studies focuses on breast milk collection for women planning postpartum treatment with Ocrevus, Rituxan, Briumvi or Kesimpta. This study is fully remote and all sample collection is optional, so participants can choose which types of samples they wish to provide. For blood draws, participants can schedule a home visit through ExamOne, making participation even more convenient. The investigators aim to enroll women with chronic neurological conditions who are planning pregnancy, currently pregnant, or within one year postpartum.

Status (registry)
Recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
19 Mar 2025
Start date
21 Mar 2017
Primary completion date
Jun 2030
Lead sponsor
University of California, San Francisco
NCT number
NCT06940323

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 21 Mar 2017 to the primary completion date, Jun 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \- Unwillingness to provide informed consent

Who the study is looking for

  • 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)

Age in the registry: 18 years to 64 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.