EligibleTrials

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

Recruiting · NCT06940323 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, San Francisco

View the official record on ClinicalTrials.gov →
Multiple Sclerosis

What this trial is 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.

Who can take part

Age range
18 Years to 64 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)

Inclusion criteria

Exclusion criteria

Where it is running

1 location listed across 1 US state.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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