Semaglutide

Exposed non-exposed, cohort studies

Study Country
Study period
Study design
Data source Exposure definition Non-exposure definition Exposition period Sample size
(exposed/unexposed) Or (case / control)
Remarks Risk of bias
Kolding (Controls exposed to insulin)
2025
Denmark
2016 - 2023
retrospective cohort
Mother–child linkage of electronic charts from all hospitals in the Central Denmark Region, via a unique identifier from the Danish Civil Registration System. Pregnancies exposed to semaglutide (ATC A10BJ06) during the first trimester (from the estimated conception date to 70 days after, corresponding to gestational age 12 0/7). exposed to other treatment, sick
Pregnancies exposed to insulin with no simultaneous use of semaglutide.
1st trimester 32 / 547 Exposed group: 27 used Ozempic (22 of these in combination with insulin), and five used Wegovy. Seventeen discontinued semaglutide in the first trimester, and 14 used semaglutide throughout all trimesters.
Exposure to semaglutide (ATC A10BJ06) and/or insulin (ATC A10B) in first trimester (from the estimated conception date to 70 days after, corresponding to GA 12 0/7), pregnancy and neonatal outcomes and informations regarding diabetes were collected from the electronic patient record.
Kolding (Controls unexposed, general pop)
2025
Denmark
2016 - 2023
retrospective cohort
Mother–child linkage of electronic charts from all hospitals in the Central Denmark Region, via a unique identifier from the Danish Civil Registration System. Pregnancies exposed to semaglutide (ATC A10BJ06) during the first trimester (from the estimated conception date to 70 days after, corresponding to gestational age 12 0/7). unexposed (general population or NOS)
Pregnancies unexposed to diabetes medications.
1st trimester 32 / 103843 Exposed group: 27 used Ozempic (22 of these in combination with insulin), and five used Wegovy. Seventeen discontinued semaglutide in the first trimester, and 14 used semaglutide throughout all trimesters.
Exposure to semaglutide (ATC A10BJ06) and/or insulin (ATC A10B) in first trimester (from the estimated conception date to 70 days after, corresponding to GA 12 0/7), pregnancy and neonatal outcomes and informations regarding diabetes were collected from the electronic patient record.
Maya
2025
USA
2016 - 2025
retrospective cohort
The Mass General Brigham, an academic health system with 15 institutions serving the greater Boston area in Massachusetts, USA. Singleton pregnancies with Semaglutide order in the electronic health record (EHR) between 3 years before and 90 days after conception. unexposed (general population or NOS)
Singleton pregnancies without Glucagon-like peptide-1 receptor agonist (GLP-1RA) medications recorded between 3 years before pregnancy and 90 days after conception.
3 months or more before pregnancy or1st trimester 247 / 741
Maternal medications were obtained in the electronic health record (EHR) from the Mass General Brigham Enterprise Data Warehouse and the Mass General Brigham Research. The exposed and unexposed classifications were validated through manual medical record review of a subset of exposed participants.

Case-control studies

Study Country
Study period
Study design
Data source Case Control Exposition Exposition period Sample size
(exposed/unexposed) Or (case / control)
Remarks Risk of bias

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

Empty. There are no case-control studies available for this drug.

master protocol