Safety of Wegovy® During Pregnancy: A Population-based Cohort Study
This study aims to observe the safety of Wegovy® during pregnancy by examining the number of infants born with major congenital malformations.
Data Collection
Collected from past medical records and data - RetrospectiveBody Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 2, 2023
Actual date on which the first participant was enrolled.This study focuses on the safety of using Wegovy® (Semaglutide 2.4 mg) during pregnancy. It is designed to compare the health outcomes of pregnant women who have used Wegovy® with those who have not, using insurance claim data. The goal is to provide valuable information that can help women and healthcare providers make informed decisions about treatment options during pregnancy. The study is important because it addresses a critical need for understanding the potential effects of Wegovy® on both the mother and the baby.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1139 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 15 to 45 Years
Range of ages for which participants are eligible to join.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Novo Nordisk Investigational Site
Princeton, United StatesOpen Novo Nordisk Investigational Site in Google Maps