| 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 |
|---|---|---|---|---|---|---|---|---|
|
Broe (Controls unexposed, general pop) 2025 |
Denmark 2004 - 2017 population based cohort retrospective |
Danish national health registries (the Danish Medical Birth registry, the Danish Civil Registration Registry, the Danish National Prescription Registry, the Danish National Patient registry and the Cause of Death Register). | 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. |
1st trimester | 56 / 482978 | Infants with chromosomal abnormalities (ICD-10 codes Q90– Q99) were excluded from all analyses. | |
| Exposure was determined using the Prescription register that contains individual-level prescription data from all Danish outpatient pharmacies. | ||||||||
|
Broe (Controls unexposed, sick) 2025 |
Denmark 2004 - 2017 population based cohort retrospective |
Danish national health registries (the Danish Medical Birth registry, the Danish Civil Registration Registry, the Danish National Prescription Registry, the Danish National Patient registry and the Cause of Death Register). | 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. |
1st trimester | 56 / 53 | Infants with chromosomal abnormalities (ICD-10 codes Q90– Q99) were excluded from all analyses. | |
| Exposure was determined using the Prescription register that contains individual-level prescription data from all Danish outpatient pharmacies. | ||||||||
|
Cesta_Israel 2024 |
Israel 2010 - 2020 retrospective cohort (claims database) |
The International Pregnancy Safety Study (InPreSS) Consortium (Israel part). | 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. |
1st trimester, 3 months or more before pregnancy or1st trimester | 43 / 422 | Use of results from sensitivity analysis with restricted period of exposure (1 month before or 1st trimester). | |
| Prescription databases (the Maccabi Health Services (MHS) database). | ||||||||
|
Cesta_Nordic 2024 |
Finland, Iceland, Norway and Sweden. 2009 - 2020 population based cohort retrospective |
The International Pregnancy Safety Study (InPreSS) Consortium (Nordic part: Finland, Iceland, Norway, Sweden). | 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. |
1st trimester, 3 months or more before pregnancy or1st 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). | |
| Prescription databases. | ||||||||
|
Cesta_USA 2024 |
USA 2012 - 2021 retrospective cohort (claims database) |
The International Pregnancy Safety Study (InPreSS) Consortium (USA part: 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. |
1st trimester, 3 months or more before pregnancy or1st trimester | 681 / 1387 | Use of results from sensitivity analysis with restricted period of exposure (1 month before or 1st trimester). | |
| Prescription databases. | ||||||||
|
Chou 2025 |
Taiwan 2014 - 2022 population based cohort retrospective |
A nationwide, population-based cohort study in Taiwan by linking two national databases: the Taiwan's Birth Certificate Application and National Health Insurance claims. | 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). |
1st trimester, 3 months or more before pregnancy or1st trimester | 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). | |
| Periconceptional exposure was ascertained from dispensed outpatient prescriptions in the National Health Insurance (NHI) claims database. | ||||||||
|
Dao (Controls exposed to metformin/insulin) 2024 |
Germany, Israel, Italy, Switzerland, and the United Kingdom. 2009 - 2022 prospective cohort |
Multicentre, prospective, observational cohort study conducted in six participating centres that are members of the European Network of Teratology Information Services (ENTIS). | 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). |
1st trimester | 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). | |
| Detailed information regarding drug exposure and drug treatment indication, including dose, timing of therapy initiation, duration and concurrent medications, is documented during the initial contact with the Teratology Information Service (TIS) (during pregnancy). | ||||||||
|
Dao (Controls unexposed, sick) 2024 |
Germany, Israel, Italy, Switzerland, and the United Kingdom. 2009 - 2022 prospective cohort |
Multicentre, prospective, observational cohort study conducted in six participating centres that are members of the European Network of Teratology Information Services (ENTIS). | 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. |
1st trimester | 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). | |
| Detailed information regarding drug exposure and drug treatment indication, including dose, timing of therapy initiation, duration and concurrent medications, is documented during the initial contact with the Teratology Information Service (TIS) (during pregnancy). | ||||||||
|
Hanif 2025 |
Worldwide (19 countries in North and South America, EMEA, and Asia-Pacific) 2005 - 2023 retrospective cohort |
The TriNetX database, a global network of healthcare organizations aggregating data from electronic health records. | 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. |
early 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). | |
| Not specified. | ||||||||
|
Kolding - Semaglutide (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 - Semaglutide (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. | ||||||||
|
Lewin 2025 |
USA 2022 - 2025 retrospective cohort (claims database) |
A retrospective cohort study using data obtained from the Epic Cosmos database, a dataset representing more than 300 million patient records from over 1,744 hospitals from all 50 states, USA. | 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. |
during pregnancy (anytime or not specified) | 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. | |
| Charts were queried (no other details). | ||||||||
|
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 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. |
3 months or more before pregnancy or1st trimester | 448 / 1344 | Table 2 data were reported here (sensitivity analyses adjusting for Body Mass Index, Chronic Hypertension, Preexisting Diabetes, and Gestational Age at Delivery). | |
| 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. | ||||||||
|
Pondugula 2025 |
USA 2014 - 2024 retrospective cohort |
One large medical center with four delivery hospitals (no other details), USA. | 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. |
3 months (or more) before pregnancy or during pregnancy, early 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). | |
| Patients with glucagon-like peptide-1 receptor agonist (GLP-1RA) exposure were identified through an electronic medical record (EMR) query with manual medical record abstraction to confirm exposure and to ascertain medication stop date relative to conception. | ||||||||
| 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;
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