Key points are not available for this paper at this time.
Semaglutide, a GLP1 agonist, is used for glycemic control in Type 2 diabetes and weight management 1. In animals (mice, rats and rabbits), GLP1 agonists is associated with embryofetal mortality, structural abnormalities and growth disturbances concerning delayed ossification and skeletal variants 2. A recent cohort study on the potential risk of malformations included GLP-1 receptor agonists but did not provide specific estimates for semaglutide 3. Except for case reports, there are no studies on other pregnancy outcomes 1, 4, 5. Unintentional use of semaglutide in pregnancy is rapidly increasing. Women who experience such exposure are difficult to advise due to the lack of human data. We report pregnancy and neonatal outcomes of pregnancies exposed to semaglutide based on data from a cohort of over 100 000 pregnancies. The study population included all singleton pregnancies surviving the first trimester in the Central Denmark Region, which accounts for one fifth of Denmark's population. This encompassed pregnancies from a gestational age (GA) of 12 + 0/7 weeks onwards, with conception dates ranging from 1 June 2016 to 22 June 2023, regardless of foetal survival. In Denmark, there is universal access to healthcare free of charge. Data were collected from the electronic charts from all hospitals in the region and linked on the individual level, including exact mother–child linkage, via a unique identifier from the Danish Civil Registration System. Exposure to semaglutide (ATC A10BJ06) and/or insulin (ATC A10B) in first trimester (from the estimated conceptiondate 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. Major malformations were classified according to EUROCAT classification including both prenatal (ultrasound data) and postnatal registered malformations as previously reported, with a deviation with reverse registration of congenital malformations (DQ) diagnoses found later in life (until June 2024) 6. The neonatal outcomes of respiratory distress syndrome (RDS), hypoglycemia and jaundice were identified using ICD10 codes (RDS DP220, 228, 229/hypoglycemia DP703, 704/jaundice DP550, 551, 558-560, 569, 570, 578-585, 588-593, 598, and 599). The outcomes of semaglutide-exposed pregnancies were compared to pregnancies exposed to either insulin or no diabetes medication. Statistical analyses were performed with Stata (Stata Corp, College Station, TX, United States). Wilcoxon ranksum test was used for numerical data and Fishers exact test for dichotomous data. Access to the data was approved according to Danish legislation (Sundhedsloven §46, permission 1-45-70-88-22, 5 April 2024), and data were stored according to the EU GDPR rules. The study was conducted in accordance with the Basic the collection, analysis and interpretation of the data; or the preparation, review or approval of the manuscript. The authors declare no conflicts of interest. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Kolding et al. (Thu,) studied this question.