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

NCT06940323 | Recruiting

• 1 other identifier: PRISMA
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Maternal Disease Activity During Pregnancy and Postpartum Assessed by Expanded Disability Status Scale (EDSS)

  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.

  From pre-pregnancy (if applicable) through 12 months postpartum

• Maternal Disease Activity During Pregnancy and Postpartum Assessed by MRI Findings

  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.

  From pre-pregnancy (if applicable) through 12 months postpartum

• Maternal Disease Treatment Course During Pregnancy and Postpartum Assessed by Disease Modifying Therapy (DMT) Use

  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.

  From pre-pregnancy (if applicable) through 12 months postpartum

• Maternal Disease Activity During Pregnancy and Postpartum Assessed by Clinical Relapse Rates

  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.

  From pre-pregnancy (if applicable) through 12 months postpartum

Secondary Outcomes (14)

• Infant Growth and Development Outcomes Assessed by Chart Review and ASQ-3

  From birth through 12 months postpartum

• Detection and Concentration of Monoclonal Antibodies in Breastmilk

  From first infusion postpartum through 12 months postpartum

• Concentration of Monoclonal Antibodies and Disease-Related Biomarkers in Maternal Blood

  From the planning pregnancy (if applicable) to 6 months postpartum

• Maternal Fatigue During Pregnancy and Postpartum Assessed by Modified Fatigue Impact Scale (MFIS)

  From pre-pregnancy (if applicable) through 12 months postpartum

• Maternal Sleep Quality During Pregnancy and Postpartum Assessed by Medical Outcomes Study Sleep Scale (MOS-SS)

  From pre-pregnancy (if applicable) through 12 months postpartum

Other Outcomes (4)

• Exploratory: Changes in Maternal Gut Microbiome Composition Following Maternal Monoclonal Antibody Treatment

  Pre-infusion through 60 days post-infusion

• Exploratory: Changes in Infant Gut Microbiome Composition Following Maternal Monoclonal Antibody Treatment

  Pre-infusion through 60 days post-infusion

• Exploratory: Infant Medical Problems Inflicting Immune Functions

  From delivery through 12 months postpartum

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult women diagnosed with multiple sclerosis (MS), clinically isolated syndrome (CIS), Neuromyelitis optica spectrum disorder (NMOSD), and/or myasthenia gravis who are planning pregnancy, currently pregnant, or postpartum.

You may qualify if:

• 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)

You may not qualify if:

• \- Unwillingness to provide informed consent

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California-San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (3)

• Anderson A, Krysko KM, Rutatangwa A, Krishnakumar T, Chen C, Rowles W, Zhao C, Houtchens MK, Bove R. Clinical and Radiologic Disease Activity in Pregnancy and Postpartum in MS. Neurol Neuroimmunol Neuroinflamm. 2021 Feb 19;8(2):e959. doi: 10.1212/NXI.0000000000000959. Print 2021 Mar.

  PMID: 33608303 BACKGROUND

• LaHue SC, Anderson A, Krysko KM, Rutatangwa A, Dorsey MJ, Hale T, Mahadevan U, Rogers EE, Rosenstein MG, Bove R. Transfer of monoclonal antibodies into breastmilk in neurologic and non-neurologic diseases. Neurol Neuroimmunol Neuroinflamm. 2020 May 27;7(4):e769. doi: 10.1212/NXI.0000000000000769. Print 2020 Jul.

  PMID: 32461351 BACKGROUND

• Anderson A, Rowles W, Poole S, Balan A, Bevan C, Brandstadter R, Ciplea AI, Cooper J, Fabian M, Hale TW, Jacobs D, Kakara M, Krysko KM, Longbrake EE, Marcus J, Repovic P, Riley CS, Romeo AR, Rutatangwa A, West T, Hellwig K, LaHue SC, Bove R. Anti-CD20 monoclonal antibody therapy in postpartum women with neurological conditions. Ann Clin Transl Neurol. 2023 Nov;10(11):2053-2064. doi: 10.1002/acn3.51893. Epub 2023 Sep 7.

  PMID: 37675826 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal blood, stool, vaginal microbiome, breastmilk sample, and infant stool sample

MeSH Terms

Conditions

Multiple Sclerosis; Myasthenia Gravis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases

Study Officials

• Riley Bove, MD, MSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Ji Kim Kim, BA

CONTACT

415-502-7209; minji.kim3@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 23, 2025
• Study Start: March 21, 2017
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2035
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)