Actively Recruiting
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Led by University of California, San Diego · Updated on 2025-01-28
200
Participants Needed
1
Research Sites
900 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
T
The Organization of Teratology Information Specialists
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
CONDITIONS
Official Title
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months before the first day of the last menstrual period
- Documentation of when the exposure to Stelara or Tremfya occurred during pregnancy
You will not qualify if you...
- No exposure to Stelara or Tremfya during pregnancy or within 3 months before the last menstrual period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
D
Diana Johnson, MS
CONTACT
C
Christina Chambers, PhD, MPH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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