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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Blood draws, MRI scans, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "For blood draws, participants can schedule a home visit through ExamOne, making participation even more convenient."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

PRISMA studies how pregnancy and long-term nerve and brain conditions relate to the health of mothers and babies. It aims to enroll women planning pregnancy, who are pregnant, or who gave birth within the past year. The study is fully remote, and giving samples is optional.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women ages 18 to 64.
  • Pregnant or thinking about becoming pregnant.
  • Have one of the listed conditions, or have no long-term condition and join the comparison group.
  • Listed conditions include multiple sclerosis (MS) or clinically isolated syndrome (CIS), a first episode of nerve symptoms, diagnosed using the study’s required rules.
  • Other listed conditions include neuromyelitis optica spectrum disorder (NMOSD), which affects nerves in the eyes and spinal cord, or another long-term nerve or brain condition.
  • Also eligible: inflammatory bowel disease (ongoing swelling in the gut) or rheumatoid arthritis (a disease that causes swollen, painful joints).
  • Also eligible: myasthenia gravis (a disease that causes muscle weakness) or lupus (a disease in which the body’s defenses attack healthy tissue).
  • Willing to give body samples, complete surveys, or both at set times.

Who can't join

  • Not willing to give informed consent, which means agreeing to join after learning about the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA