A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy

Registered clinical trial record on ClinicalTrials.gov (NCT05503927). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: enrolling by invitation. Study type: observational. Sponsor: Novo Nordisk A/S. Conditions: Pregnancy, Obesity, Overweight. Interventions: No Intervention. Summary: 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. Primary outcome measures: Number of Infants with Major Congenital Malformation (MCM). Eligibility: Inclusion Criteria: * Evidence of a pregnancy end event on a medical claim (example, live birth, stillbirth, or spontaneous abortion) during the pregnancy identification period (that is, 04 June 2021 - 17 February 2027). * Aged 15-45 and female on the date of the last menstrual period (LMP). * Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of LMP through 42 days after the pregnancy end date. * Among the pregnancies that meet the inclusion criteria, three main cohorts of interest and two sub cohorts will be identified (one Wegovy-exposed cohort and two comparison cohorts): * Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from estimated conception date (LMP +14) - 35 days to end of pregnancy. * Other AOM-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone exposure, defined as the following: * Benzphetamine, diethylpropion, orlistat, or phendimetrazine exposure from estimated conception date-1 day to end of pregnancy. * Phentermine or bupropion/naltrexone exposure from estimated conception date- 5 days to end of pregnancy. * Cohort with Overweight/Obesity- * Greater than or equal to 1 diagnosis code for obesity or BMI greater than or equal to 30 kilogram per meter square (kg/m\^2) on a medical claim during the six month pre-pregnancy period. * Greater than or equal to 1 diagnosis code for BMI greater than or equal to 27 kg/m\^2 or less than 30 kg/m\^2 on a medical claim and greater than or equal to 1 non-diagnostic medical claim for dyslipidemia, type 2 diabetes mellitus, or hypertension during the six month pre-pregnancy period. * No exposure to Wegovy or other AOM during the defined exposure window in pregnancy. * Among Wegovy-exposed and Other AOM-exposed pregnancies, the subset with first trimester exposures will be identified as those with greater than or equal to 1 days of exposure at \< less than 14 WGA. Exclusion Criteria: * Pregnancies exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (estimated conception date - 35 days through pregnancy end date). * Pregnancies with exposure to both Wegovy and other AOM during the exposure identification window (estimated conception date - 35 days through pregnancy end date). * Pregnancies resulting in multiple infants will be excluded from the analysis of infant outcomes.