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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California-San Francisco, San Francisco, California, United States, 94158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of California, San Francisco,

Riley Bove, MD, MSc, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2035-06