Glucagon-like peptide-1 (GLP-1) receptor agonists

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Broe (Controls unexposed, general pop), 2025	population based cohort retrospective	Exposure was determined using the Prescription register that contains individual-level prescription data from all Danish outpatient pharmacies.	Malformations were identified using infant records from three Danish health registries: The Birth register, the Patient register, and the Cause of Death Register during the first year of life.	Singleton only. Multivariable model including calendar year, maternal age at delivery, body mass index (BMI), smoking status, parity, and concurrent exposure to known teratogenic drugs during the first trimester.
Broe (Controls unexposed, sick), 2025	population based cohort retrospective	Exposure was determined using the Prescription register that contains individual-level prescription data from all Danish outpatient pharmacies.	Malformations were identified using infant records from three Danish health registries: The Birth register, the Patient register, and the Cause of Death Register during the first year of life.	Singleton only. Multivariable model including calendar year, maternal age at delivery, body mass index (BMI), smoking status, parity, and concurrent exposure to known teratogenic drugs during the first trimester.
Cesta_Israel, 2024	retrospective cohort (claims database)	Prescription databases (the Maccabi Health Services (MHS) database).	The presence of any major congenital malformations overall and the subgroup of major cardiac malformations were identified using diagnosis and procedure codes based on healthcare databases.	Singletons only. Exclusion of infants with early pregnancy exposure to known teratogenic drugs. Adjusted for birth year, maternal age, obesity, and specific Nordic country.
Cesta_Nordic, 2024	population based cohort retrospective	Prescription databases.	The presence of any major congenital malformations overall and the subgroup of major cardiac malformations were identified using diagnosis and procedure codes based on healthcare databases.	Singletons only. Exclusion of infants with early pregnancy exposure to known teratogenic drugs. Adjusted for birth year, maternal age, obesity, and specific Nordic country.
Cesta_USA, 2024	retrospective cohort (claims database)	Prescription databases.	The presence of any major congenital malformations overall and the subgroup of major cardiac malformations were identified using diagnosis and procedure codes based on healthcare databases.	Exclusion of infants with early pregnancy exposure to known teratogenic drugs. Adjusted for birth year, maternal age, obesity.
Chou, 2025	population based cohort retrospective	Periconceptional exposure was ascertained from dispensed outpatient prescriptions in the National Health Insurance (NHI) claims database.	The National Health Insurance (NHI) database that contains complete records of outpatient and inpatient visits, diagnostic codes (ICD, 9th and 10th Revisions), procedures and the National Birth Certificate Application (BCA) that contains clinician-reported congenital anomalies.	Singletons only. Exclusion of pregnancies exposed to a known teratogen during the first trimester or with a chromosomal abnormality. Main analysis: Propensity score matching for maternal age, obesity, tobacco, alcohol, drug use, comorbidities (hypertension, diabetic complications, hyperlipidaemia, polycystic ovary syndrome), medication use, obstetric comorbidity index, healthcare use.
Dao (Controls exposed to metformin/insulin), 2024	prospective cohort	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).	After the expected date of delivery, follow-up is conducted through structured mailed questionnaires and/or a structured telephone interview administered to the patient and/or their healthcare provider. Birth defects were classified by two coauthors who were blinded to exposure data.	Exclusion criteria for all three groups included exposure to any teratogenic drugs, and multiple pregnancies. Birth defects: adjusted for maternal age, number of previous pregnancies and polymedication. For intrauterine deaths: adjusted for maternal age, squared maternal age and binary variables including tobacco use, folate supplementation, past ETOP and past abortions.
Dao (Controls unexposed, sick), 2024	prospective cohort	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).	After the expected date of delivery, follow-up is conducted through structured mailed questionnaires and/or a structured telephone interview administered to the patient and/or their healthcare provider. Birth defects were classified by two coauthors who were blinded to exposure data.	Exclusion criteria for all groups: exposure to any teratogenic drugs, and multiple pregnancies. Birth defects: adjusted for maternal age, number of previous pregnancies and polymedication. For intrauterine deaths: adjusted for maternal age, squared maternal age and binary variables including tobacco use, folate supplementation, past ETOP and past abortions.
Hanif, 2025	retrospective cohort	Not specified.	Not specified.	Propensity score for age, race, body mass index, hypertension, chronic kidney disease, hypothyroidism, iron deficiency anemia, overweight and obesity, smoking history, alcohol, cocaine, cannabis, opioid and inhalant abuse, antidepressants, insulin, beta-blockers, statins, and SGLT2i, hemoglobin, glycated hemoglobin, low-density lipoprotein, serum creatinine, and left ventricular ejection fraction.
Kolding - Semaglutide (Controls exposed to insulin), 2025	retrospective cohort	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.	Data were collected from the electronic charts from all hospitals in the region.	Singletons only. No adjustment.
Kolding - Semaglutide (Controls unexposed, general pop), 2025	retrospective cohort	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.	Data were collected from the electronic charts from all hospitals in the region.	Singletons only. No adjustment.
Lewin, 2025	retrospective cohort (claims database)	Charts were queried (no other details).	Charts were queried (no other details) and outcomes identified by ICD-10 diagnosis codes.	None.
Maya, 2025	retrospective cohort	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.	Maternal anthropometric and delivery data were obtained from the Mass General Brigham Enterprise Data Warehouse; additional maternal diagnostics were obtained from the Mass General Brigham Research. Prepregnancy weight was self-reported and documented in the electronic health record (EHR).	Singleton only. Propensity score (and/or adjusted): body mass index, maternal age, parity, race and ethnicity, insurance type, preexisting diabetes (except for gestational diabetes analysis because this group was excluded), preexisting chronic hypertension (except for hypertensive disorders of pregnancy analysis because this group was excluded), year of delivery, and delivery location.
Pondugula, 2025	retrospective cohort	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.	Outcomes based on the electronic medical record (EMR) data from an existing institutional obstetric data repository. This repository includes standardized and templated data fields including recorded diagnoses ([ICD-10] codes and billing codes (Current Procedural Terminology).	Multiple gestations were excluded. Patients did not differ by age, insurance status, parity, race and ethnicity, or chronic hypertension diagnosis. Hypertensive disorders: adjusted for parity, chronic hypertension diagnosis, gestational diabetes mellitus, preterm birth, polycystic ovarian syndrome diagnosis, gestational weight gain, and age.

master protocol