Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06940323

Conditions

Multiple Sclerosis

Clinically Isolated Syndrome

NMOSD

Myasthenia Gravis

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Multiple Sclerosis

Clinically Isolated Syndrome

NMOSD

Myasthenia Gravis

Study ID

NCT06940323

Start date

Mar 21, 2017

Status verified date

Aug, 2026

Completion date

Jun, 2035

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Accepted

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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Controls

Healthy adult women who are planning pregnancy, currently pregnant, or postpartum.

Multiple sclerosis (MS)

Adult women diagnosed with multiple sclerosis (MS) who are planning pregnancy, currently pregnant, or postpartum.

Clinically isolated syndrome (CIS)

Adult women diagnosed with clinically isolated syndrome (CIS) who are planning pregnancy, currently pregnant, or postpartum.

Neuromyelitis optica spectrum disorder (NMOSD)

Adult women diagnosed with neuromyelitis optica spectrum disorder (NMOSD) who are planning pregnancy, currently pregnant, or postpartum.

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 ]
  • Maternal Disease Activity During Pregnancy and Postpartum Assessed by MRI Findings [ Time Frame: From pre-pregnancy (if applicable) through 12 months postpartum ]
  • Maternal Disease Treatment Course During Pregnancy and Postpartum Assessed by Disease Modifying Therapy (DMT) Use [ Time Frame: From pre-pregnancy (if applicable) through 12 months postpartum ]
  • Maternal Disease Activity During Pregnancy and Postpartum Assessed by Clinical Relapse Rates [ Time Frame: From pre-pregnancy (if applicable) through 12 months postpartum ]

Central Contacts and Locations

Central contacts

Locations

University of California-San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Riley Bove

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.