Pantoprazole

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.
Choi, 2023	retrospective cohort (claims database)	Prescription database.	The National Health Insurance Service (NHIS) database.	Propensity score: maternal age, medical aid, income level, parity, multiple gestations, indications for PPIs (GERD, duodenitis...), maternal conditions (eg, anxiety, diabetes, and epilepsy), other medication prescription, obstetric comorbidity index, and measures of health care use. Sensitivity analyses: indications, singleton only, body mass index, smoking, sibling design, first-time pregnancy.
Diav-Citrin, 2005	prospective cohort	Details of exposure were collected during pregnancy before pregnancy outcome was known, using a structured questionnaire.	After the expected date of delivery, follow-up was conducted with the woman, her physician or midwife by a telephone interview and/or mailed questionnaire to obtain details on the pregnancy outcome.	None.
Pasternak, 2010	population based cohort retrospective	The Prescription Drug Register provided information on all pantoprazole prescriptions filled by women in the cohort between 4 weeks before conception and delivery.	Cases of birth defects were identified with the use of the National Patient Register and a random sample had a medical records review. Major birth defects were defined according to the EUROCAT classification.	No potential confounder stood out as an important one, therefore, as an alternative all potential confounders and their effect were sum up into one variable: the propensity score.

master protocol