The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.
Study Type
OBSERVATIONAL
Enrollment
2,828
Women with UC exposed to ozanimod during pregnancy
Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy
Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy
OptumInsight Life Sciences Inc
Eden Prairie, Minnesota, United States
Prevalence of major congenital malformations among infants
To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy.
Time frame: Up to 10 years
Number of spontaneous abortions
Time frame: Up to 10 years
Number of stillbirths
Time frame: Up to 10 years
Number of participants with pre-eclampsia
Time frame: Up to 10 years
Number of participants with eclampsia
Time frame: Up to 10 years
Number of preterm births
Time frame: Up to 10 years
Number of infants small for gestational age
Time frame: Up to 10 years
Number of serious or opportunistic infections in liveborn infants up to 1 year of age
Time frame: Up to 10 years
Number of infant postnatal growth deficiencies
Time frame: Up to 10 years
Number of infant developmental deficiencies
Time frame: Up to 10 years
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Number of neonatal hospitalizations
Time frame: Up to 10 years
Number of infant deaths
Time frame: Up to 10 years
Number of neonatal deaths
Time frame: Up to 10 years
Number of perinatal deaths
Time frame: Up to 10 years