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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Myasthenia Gravis; Multiple Sclerosis; NMOSD; Clinically Isolated Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT06940323

PRISMA

Details and patient eligibility

About

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.

Full description

The aim of this project is to develop a repository of samples for women who are pregnant and have chronic conditions, including demyelinating diseases -- either multiple sclerosis (MS), clinically isolated syndrome (CIS) or NMOSD (neuromyelitis optica spectrum disorders), chronic inflammation --- inflammatory bowel disease (IBD), rheumatoid arthritis (RA), lupus, myasthenia gravis (MG), primary headache disorders, or other chronic neurological conditions. Please note that the investigators refer to "MS" in the rest of the application.

This repository will include:

1. Maternal Outcomes (disease-related outcomes, depression, social support, breastfeeding and pregnancy-related outcomes):

   • Obtained via interviews, surveys, and medical record review during pregnancy planning, pregnancy (Baseline and 36w gestation) and postpartum (1, 4, 8, 12M)
   • Maternal radiographic information will be collected from data available in the medical records. [Radiographic information will be information captured from the medical record, not obtained during the study visits. No radiology exams will be conducted as part of this research study. If deemed necessary for the subject's routine clinical care, the investigators will record the results of an MRI within 12M postpartum.]

2. Infant Outcomes (growth, development, immunization, infection, breastfeeding, etc.)

   • Obtained via medical record review (up to 12M)
   • Monitored via maternal completion of the Ages and Stages Questionnaires-Version 3 (ASQ3) to track infant development outcomes (communication, gross motor, fine motor, problem solving, and person-social) at 2, 4, 6, 8, 10, and 12M of age.

3. Biospecimen Collection, Storage & Later Batch Analysis:

   • Maternal blood samples will be collected for up to the following time points: Baseline (including if planning pregnancy), 3M gestation, 6M gestation, 8M gestation, 1M postpartum, 3M postpartum, and 6M postpartum. Samples will be processed and stored as serum, plasma and peripheral blood mononuclear cells (PBMCs).

   • Serial breastmilk samples will be collected, for both before and after treatment if applicable, and up to 2-3 years postpartum. These samples will be used to determine the concentrations of medications in breastmilk relative to maternal serum.

   • Serial maternal and infant gut microbiome samples will be collected before and after treatment (anytime during the lactation period which can extend up to 2-3 years postpartum) to determine the effect of mAb treatment on gut microbial populations in mothers and infants. Mothers will be asked to complete food frequency questionnaires for themselves and their infants at the time of each sample collection.

   • Maternal vaginal swab sample will be collected in their 36 weeks of gestation (OR 8M pregnancy) to determine the effect of mAb treatment on vaginal microbial populations in mothers. Mothers will be asked to complete questionnaires regarding their diet and medication for themselves at the time of each sample collection.

   • Serial maternal blood samples will be collected (including before and post treatment) anytime up to 2-3 years postpartum. These samples will be used to determine concentrations of medications in breastmilk relative to serum and to determine the effect of maternal treatment on mother and infant gut microbiome.

     • Timing of sample collection for participants treated with mAb will depend on the treatment type, dosing and infusion schedule.

Participants who are healthy controls or who are not receiving specific medications of interest will provide

• A single breastmilk sample at 2M, 3M, and 4M
• A maternal and infant gut microbiome sample at 2M, 3M, and 4M postpartum
• Maternal vaginal swab sample at 36 weeks of gestation (OR 8M pregnancy).
• Maternal blood samples will be collected at corresponding timepoints 2M, 3M and 4M postpartum (to be processed and stored as serum, plasma, and PBMCs)

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

250 participants in 5 patient groups

Healthy Controls

Description:

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

Multiple sclerosis (MS)

Description:

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

Clinically isolated syndrome (CIS)

Description:

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

Neuromyelitis optica spectrum disorder (NMOSD)

Description:

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

Myasthenia gravis

Description:

Adult women diagnosed with myasthenia gravis who are planning pregnancy, currently pregnant, or postpartum.