This is an observational, retrospective, cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.
Study Type
OBSERVATIONAL
Enrollment
1,139
This is a non-interventional study, therefore no intervention is used.
Novo Nordisk Investigational Site
Princeton, New Jersey, United States
Number of Infants with Major Congenital Malformation (MCM)
Number of infants with MCM is defined as an abnormality of body structure or function that is present at birth, is of prenatal origin (that is, birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
Time frame: Birth up to 1 year of age
Number of Infants Experiencing Small for Gestational Age (SGA) Birth
Number of infants experiencing small for gestational age is defined as weight at birth in less than (\<) 10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Time frame: Birth up to 1 year of age
Number of infants with Developmental Delay
Infant development delay will be defined as infants with evidence of one or more of the following outcomes in the first year of life: delayed milestone in childhood, other lack of normal physiological development, special screening for developmental disabilities.
Time frame: Birth up to 1 year of age
Number of Infants With Postnatal Growth Deficiency
Number of infants with adverse postnatal growth will be defined as infants with evidence of the following outcomes in the first year of life: abnormal weight gain (insufficient or excessive weight gain), short stature, failure to thrive.
Time frame: Birth up to 1 year of age
Number of Pregnant Participants Experiencing Stillbirth
Number of pregnant participants experiencing still birth is defined as an involuntary fetal loss occurring at greater than or equal to (\>=20) WGA.
Time frame: up to 37 weeks of gestational age
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Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB)
Number of pregnant participants experiencing SAB is defined as an involuntary fetal loss or the expulsion of the products of conception occurring at \<20 WGA.
Time frame: up to 37 weeks of gestational age
Number of Pregnant Participants With Preterm Delivery
Preterm birth is defined as a live birth occurring at \<37 WGA.
Time frame: Up to 37 weeks of gestational age
Number of Pregnant Participants With Pre-eclampsia/eclampsia
Pre-eclampsia/eclampsia is defined as new onset of hypertension with proteinuria occurring at \>=20WGA through the six weeks following pregnancy end.
Time frame: Up to 37 weeks of gestational age