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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
View:

• 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)

Locations
United States
California
University of California-San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Min Ji Kim Kim, BA
minji.kim3@ucsf.edu
415-502-7209
Time Frame
Start Date: 2017-03-21
Estimated Completion Date: 2035-06
Participants
Target number of participants: 250
Treatments
Healthy Controls
Healthy adult women who are planning pregnancy, currently pregnant, or postpartum.
Multiple sclerosis (MS)
Adult women diagnosed with multiple sclerosis (MS) who are planning pregnancy, currently pregnant, or postpartum.
Clinically isolated syndrome (CIS)
Adult women diagnosed with clinically isolated syndrome (CIS) who are planning pregnancy, currently pregnant, or postpartum.
Neuromyelitis optica spectrum disorder (NMOSD)
Adult women diagnosed with neuromyelitis optica spectrum disorder (NMOSD) who are planning pregnancy, currently pregnant, or postpartum.
Myasthenia gravis
Adult women diagnosed with myasthenia gravis who are planning pregnancy, currently pregnant, or postpartum.
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov