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OTIS Cimzia Pregnancy Registry
Sponsor: University of California, San Diego
Summary
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 five years 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.
Official title: Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
925
Start Date
2012-03
Completion Date
2026-03
Last Updated
2025-01-28
Healthy Volunteers
Yes
Locations (1)
University of California, San Diego
San Diego, California, United States