Bisoprolol (versus unexposed)

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Delteil, 2024	retrospective cohort (claims database)	Women's drug exposure during pregnancy was estimated on the basis of dispensed prescription drugs recorded by the French Assurance Maladie.	Pregnancy outcomes were obtained from compulsory health certificates at 8 days, 9 months and 2 years for children recorded by the Protection Maternelle et Infantile (PMI) for births, and from data from the Primary Health Insurance Fund and the Toulouse University Hospital.	For malformations: adjusted for folic acid intake, the number of other medications during pregnancy, exposure to at least one teratogenic drug, diabetes and maternal age.
Fitton (Controls unexposed, disease free), 2020	retrospective cohort (claims database)	The Prescribing Information System which collects information on encashed prescriptions issued by primary care and dispensed from community pharmacies for all Scottish residents.	The Scottish Morbidity Record 02 database, which collects data on maternal, obstetric, and child outcomes.	Adjusted for: Maternal body mass index, maternal diabetes, parity, smoking status, maternal age, preeclampsia, Scottish Index of Multiple Deprivation (SIMD) quintile, drug misuse, alcohol intake, previous stillbirths and interactions. Only singleton live birth.
Fitton (Controls unexposed, sick), 2020	retrospective cohort (claims database)	The Prescribing Information System which collects information on encashed prescriptions issued by primary care and dispensed from community pharmacies for all Scottish residents.	The Scottish Morbidity Record 02 database, which collects data on maternal, obstetric, and child outcomes.	No adjustment for this group of comparison. Only singleton live birth.
Hoeltzenbein, 2018	prospective cohort	At the initial contact (during pregnancy) maternal characteristics and detailed exposure assessment are asked for after informed consent. The outcome of pregnancy was not known at the time of enrollment.	About 8 weeks after the estimated date of birth, information on course and outcome of pregnancy is collected via structured telephone interview or mailed questionnaires. For neonates, information on the third German pediatric examination at age of 4– 5 weeks is included.	Adjusted fo maternal age, body mass index, pregestational diabetes, alcohol consumption, smoking status, and numbers of previous deliveries, previous spontaneous abortions and previous children with birth defects. Pregnancies exposed to known teratogens such as vitamin-K antagonists, valproate, methotrexate or mycophenolate were excluded from the exposed and the control groups.
Ishibashi, 2017	retrospective cohort	All data were collected with checking their maternity record book.	All data were collected with checking their maternity record book. The infants’ data (premature birth and low birth weight) was collected from the patients’ maternity records.	None.
Tanaka, 2016	retrospective cohort	Patient data were collected from their medical records and included medication(s) used (β-blockers and other ones).	Patient data were collected from their medical records.	No adjustment for this group of exposure. Singleton only. Smoking and alcohol consumption during pregnancy not observed in any of the patients. No significant differences in gestational DM and pregnancy-induced hypertension between the 3 groups.
Vaclavik, 2024	population based cohort retrospective	The National Registry of Reimbursable Health Services (NRHZS).	Nationwide data on all births and abortions in the Czech Republic were obtained from the National Registry of Reproductive Health (NRRZ).	None.

master protocol