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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06940323
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 21, 2017
Status verified
Apr 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2035

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Healthy Controls
    Healthy adult women who are planning pregnancy, currently pregnant, or postpartum.
  • Arm: Multiple sclerosis (MS)
    Adult women diagnosed with multiple sclerosis (MS) who are planning pregnancy, currently pregnant, or postpartum.
  • Arm: Clinically isolated syndrome (CIS)
    Adult women diagnosed with clinically isolated syndrome (CIS) who are planning pregnancy, currently pregnant, or postpartum.
  • Arm: Neuromyelitis optica spectrum disorder (NMOSD)
    Adult women diagnosed with neuromyelitis optica spectrum disorder (NMOSD) who are planning pregnancy, currently pregnant, or postpartum.
  • Arm: Myasthenia gravis
    Adult women diagnosed with myasthenia gravis who are planning pregnancy, currently pregnant, or postpartum.

Primary Outcome Measure

Maternal Disease Activity During Pregnancy and Postpartum Assessed by Expanded Disability Status Scale (EDSS) [ Time Frame: From pre-pregnancy (if applicable) through 12 months postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California-San FranciscoSan FranciscoCalifornia94158
Min Ji Kim
[email protected]
415-502-7209
Ayushi Balan
[email protected]
415-514-8330
Riley Bove (PRINCIPAL_INVESTIGATOR)

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