| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| Broe (Controls unexposed, general pop), 2025 |
Denmark 2004 - 2017 |
All singleton livebirths in Denmark between January 1, 2004, and December 31, 2017. | Singleton livebirths whose mothers had filled a prescription for Glucagon-like peptide-1 (GLP-1) analogues between the first day in the last menstrual period (LMP) and the end of the first trimester (91days after LMP). |
unexposed (general population or NOS)
Singleton livebirths of women who did not redeem any drug prescription between 90 days prior to LMP and the end of the first trimester. |
56 / 482978 | Infants with chromosomal abnormalities (ICD-10 codes Q90– Q99) were excluded from all analyses. |
| Broe (Controls unexposed, sick), 2025 |
Denmark 2004 - 2017 |
All singleton livebirths in Denmark between January 1, 2004, and December 31, 2017. | Singleton livebirths whose mothers had filled a prescription for Glucagon-like peptide-1 (GLP-1) analogues between the first day in the last menstrual period (LMP) and the end of the first trimester (91days after LMP). |
unexposed, sick
Singleton livebirths born to women who were treated with the individual drug of interest during the last year before pregnancy, but not during pregnancy. |
56 / 53 | Infants with chromosomal abnormalities (ICD-10 codes Q90– Q99) were excluded from all analyses. |
| Cesta_Israel, 2024 |
Israel 2010 - 2020 |
All pregnancies in women with pregestational type 2 diabetes resulting in singleton live-born infants in the Maccabi Health Services (MHS) database. | Pregnancies in women with pregestational type 2 diabetes with periconceptional exposure to GLP-1 receptor agonists defined as the filling of 1 or more prescriptions from 90 days before the first day of the last menstrual period (LMP) to the end of the first trimester. |
exposed to other treatment, sick
Pregnancies in women with pregestational type 2 diabetes with periconceptional exposure to insulin defined as the filling of 1 or more prescriptions from 90 days before the first day of the last menstrual period (LMP) to the end of the first trimester. |
43 / 422 | Use of results from sensitivity analysis with restricted period of exposure (1 month before or 1st trimester). |
| Cesta_Nordic, 2024 |
Finland, Iceland, Norway and Sweden. 2009 - 2020 |
All pregnancies in women with pregestational type 2 diabetes resulting in singleton live-born infants in 4 European Nordic countries. | Pregnancies in women with pregestational type 2 diabetes with periconceptional exposure to GLP-1 receptor agonists defined as the filling of 1 or more prescriptions from 90 days before the first day of the last menstrual period (LMP) to the end of the first trimester. |
exposed to other treatment, sick
Pregnancies in women with pregestational type 2 diabetes with periconceptional exposure to insulin defined as the filling of 1 or more prescriptions from 90 days before the first day of the last menstrual period (LMP) to the end of the first trimester. |
214 / 3269 | Use of results from sensitivity analysis with restricted period of exposure (1 month before or 1st trimester). Finland (2009-2016), Iceland (2009-2017), Norway (2009-2020), Sweden (2009-2019). |
| Cesta_USA, 2024 |
USA 2012 - 2021 |
All pregnancies in women with pregestational type 2 diabetes resulting in live-born (singleton and multiple) infants included in the MarketScan Research Database. | Pregnancies in women with pregestational type 2 diabetes with periconceptional exposure to GLP-1 receptor agonists defined as the filling of 1 or more prescriptions from 90 days before the first day of the last menstrual period (LMP) to the end of the first trimester. |
exposed to other treatment, sick
Pregnancies in women with pregestational type 2 diabetes with periconceptional exposure to insulin defined as the filling of 1 or more prescriptions from 90 days before the first day of the last menstrual period (LMP) to the end of the first trimester. |
681 / 1387 | Use of results from sensitivity analysis with restricted period of exposure (1 month before or 1st trimester). |
| Chou, 2025 |
Taiwan 2014 - 2022 |
Pregnancies among women with pregestational Type 2 diabetes mellitus (T2DM), aged 18–50 years that resulted in a singleton birth between January 1, 2014, and December 31, 2022. | Pregnant women with pregestational Type 2 diabetes mellitus (T2DM) periconceptionnally exposed to any glucagon-like peptide-1 receptor agonist (GLP-1 RA), i.e dispensed during the 90 days before and after the last menstrual period. |
exposed to other treatment, sick
Pregnant women with pregestational Type 2 diabetes mellitus (T2DM) and with any dispensing of insulin but no exposure to a glucagon-like peptide-1 receptor agonist (GLP-1 RA). |
160 / 606 | Use of results from sensitivity analysis with restricted period of exposure (1st trimester). Result (RR) for major malformations with periconceptionnal exposure not reported here because of the inconsistency with raw data (e-mail sent to authors). |
| Dao (Controls exposed to metformin/insulin), 2024 |
Germany, Israel, Italy, Switzerland, and the United Kingdom. 2009 - 2022 |
The pregnant patients, or their healthcare providers, that contacted one of the six participating Teratology Information Services for a risk assessment during pregnancy. | Pregnant women (with pre-gestational diabetes and/or overweight/obesity) exposed to any Glucagon-like peptide 1 receptor agonists (GLP1-RA) (identified by ATC codes A10BJ, A10AE54 or A10AE56) either as monotherapy or in combination with other medications during the first trimester of pregnancy. |
exposed to other treatment, sick
Pregnant women with pre-existing diabetes mellitus, who were exposed to non-GLP1-RA antidiabetic drugs during the first trimester of pregnancy (in most cases metformin, then insulin). |
168 / 156 | Liraglutide (n=99), semaglutide (n=51), dulaglutide (n=11) and exenatide (n=7). GLP1-RA indications: weight loss (n=117, 70%), diabetes (n=46, 28%) and others (n=4, 2%). GLP1-RA stopped at a median GA of 5 weeks (IQR 4–6 GW; min: 2 GW, max:40 GW). |
| Dao (Controls unexposed, sick), 2024 |
Germany, Israel, Italy, Switzerland, and the United Kingdom. 2009 - 2022 |
The pregnant patients, or their healthcare providers, that contacted one of the six participating Teratology Information Services for a risk assessment during pregnancy. | Pregnant women (with pre-gestational diabetes (27%) and/or overweight/obesity (87%)) exposed to any Glucagon-like peptide 1 receptor agonists (GLP1-RA) (ATC codes A10BJ, A10AE54 or A10AE56) either as monotherapy or in combination with other medications during the first trimester of pregnancy. |
unexposed, sick
Pregnant women with overweight/obesity and without pre-existing diabetes mellitus, who were not exposed to GLP1-RA antidiabetic drugs during the first trimester of pregnancy. |
168 / 163 | Liraglutide (n=99), semaglutide (n=51), dulaglutide (n=11) and exenatide (n=7). GLP1-RA indications: weight loss (n=117, 70%), diabetes (n=46, 28%) and others (n=4, 2%). GLP1-RA stopped at a median GA of 5 weeks (IQR 4–6 GW; min: 2 GW, max:40 GW). |
| Hanif, 2025 |
Worldwide (19 countries in North and South America, EMEA, and Asia-Pacific) 2005 - 2023 |
Pregnant women with type 2 diabetes mellitus (T2D) (≥18 years of age) with visits from June 2005 to February 2023. | Pregnant women with type 2 diabetes mellitus (T2D) with exposure to Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) within 1 year before and 1 month after diagnosis of first-trimester pregnancy. |
unexposed, sick
Pregnant women with type 2 diabetes mellitus (T2D) without Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) within 1 year before and 1 month after diagnosis of first-trimester pregnancy. |
1873 / 1826 | All matched pregnancies: The most common comorbidities were obesity (75.6%), followed by hypertension (45%) and hypothyroidism (14.8%). RR not available for all outcomes (only provided on a figure). |
| Kolding - Semaglutide (Controls exposed to insulin), 2025 |
Denmark 2016 - 2023 |
All singleton pregnancies surviving the first trimester in the Central Denmark Region, which accounts for one fifth of Denmark's population. | 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. |
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. |
| Kolding - Semaglutide (Controls unexposed, general pop), 2025 |
Denmark 2016 - 2023 |
All singleton pregnancies surviving the first trimester in the Central Denmark Region, which accounts for one fifth of Denmark's population. | 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. |
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. |
| Lewin, 2025 |
USA 2022 - 2025 |
Pregnancies in patients with a diagnosis of pregestational diabetes or type 1 or type 2 diabetes mellitus (T1DM or T2DM) by ICD-10 codes between May 1, 2022 and April 30, 2025. | Pregnancies in patients with pregestational diabetes (T1DM and T2DM) and any glucagon-like peptide-1 receptor agonists (GLP-1 RA) use in pregnancy, which could include GLP-1 RA use at any time for any duration in pregnancy. |
unexposed, sick
Pregnancies in patients with pregestational diabetes (T1DM and T2DM) without glucagon-like peptide-1 receptor agonists (GLP-1 RA) use in pregnancy. |
40929 / 131279 | Of the total cohort, 92.6% (n=132,971) of patients had T2DM. Developed pre-eclampsia not reported because not sure thate exposure occurred before outcome. |
| Maya, 2025 |
USA 2016 - 2025 |
Singleton pregnancies with delivery dates between June 1, 2016, and March 31, 2025, at Mass General Brigham, an academic health system with 15 institutions serving the greater Boston area in Massachusetts. | Singleton pregnancies with at least 1 Glucagon-like peptide-1 receptor agonist (GLP-1RA) medication 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. |
448 / 1344 | Table 2 data were reported here (sensitivity analyses adjusting for Body Mass Index, Chronic Hypertension, Preexisting Diabetes, and Gestational Age at Delivery). |
| Pondugula, 2025 |
USA 2014 - 2024 |
All patients with a delivery admission encounter between 2014 and 2024 in one large medical center with four delivery hospitals. | Patients with weight management for elevated body mass index exposed to glucagon-like peptide-1 receptor agonist (GLP-1RA) up to 1 year before pregnancy or during pregnancy or both. |
unexposed, sick
Patients with elevated body mass index (>30) who were not on antihyperglycemic medication up to 1 year before pregnancy. |
140 / 200 | Combined indications: Eighty-four (34.6%) individuals had prepregnancy-only exposure, and 159 (65.4%) had some exposure during pregnancy. The 'pregestational diabetes' cohort not reported here because compared to other treatments (not specified). |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|
7 studies, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.