The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.
Study Type
OBSERVATIONAL
Enrollment
1,182
Evidera INC.
Bethesda, Maryland, United States
RECRUITINGEvidera
Bethesda, Maryland, United States
RECRUITINGMarienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum
Herne, Germany
RECRUITINGMajor congenital malformations
Time frame: Up to first year of life
Minor congenital malformations
Time frame: Up to first year of life
Pre-eclampsia
Time frame: Through pregnancy
Eclampsia
Time frame: Through pregnancy
Spontaneous abortion
Time frame: Through pregnancy
Stillbirth
Time frame: Through pregnancy
Elective termination
Time frame: Through pregnancy
Preterm birth
Time frame: Through pregnancy
Small for gestational age
Time frame: Up to first year of life
Postnatal growth deficiency
Time frame: Up to first year of life
Infant developmental deficiency
Time frame: Up to first year of life
Perinatal death
Time frame: Up to first year of life
Neonatal death
Time frame: Up to first year of life
First line of the email MUST contain the NCT# and Site #.
CONTACT
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Infant death
Time frame: Up to first year of life
Serious or opportunistic infant infection (SOI)
Time frame: Up to first year of life