RecruitingNCT06940323

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

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


Sponsor

University of California, San Francisco

Enrollment

250 participants

Start Date

Mar 21, 2017

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This registry study is tracking pregnant women (or those planning pregnancy) who have chronic conditions like multiple sclerosis, lupus, rheumatoid arthritis, or inflammatory bowel disease. It collects blood, breast milk, and survey data to understand how these conditions and their treatments affect pregnancy and babies. **You may be eligible if...** - You are a woman aged 18–64 who is pregnant or thinking about becoming pregnant - You have been diagnosed with MS, neuromyelitis optica, inflammatory bowel disease, rheumatoid arthritis, myasthenia gravis, lupus, or another chronic neurological condition - You are willing to provide blood/milk samples and complete surveys at set time points - Healthy pregnant women without a chronic condition can also join as a comparison group **You may NOT be eligible if...** - You are unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

University of California-San Francisco

San Francisco, California, United States

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NCT06940323


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