The purpose of the OTIS Autoimmune disease 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 that 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.
Study Type
OBSERVATIONAL
Enrollment
944
University of California, San Diego
La Jolla, California, United States
Major malformations
The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects of newborns.
Time frame: Throughout pregnancy and up to 1 year of life
Minor malformations
One secondary objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to potential minor malformations.
Time frame: At dysmorphological exam
Pregnancy outcome
Another objective of the study is to evaluate the effects of certain medications when used during pregnancy with respect to spontaneous abortion, stillbirth, and preterm delivery.
Time frame: Throughout pregnancy
Infant follow-up
Pre- and post-natal fetal and infant growth, health and development
Time frame: Throughout pregnancy and up to 1 year of life
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