Valsartan (versus unexposed)

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
Hoeltzenbein 2018	Germany 2000 - 2014 prospective cohort	The German Embryotox pharmacovigilance institute in Berlin, Germany.	Pregnancies in hypertensive women with Valsartan exposure in the first trimester of pregnancy.	unexposed, disease free Pregnant women randomly selected among those ascertained through risk consultation without a diagnosis of hypertension or treatment of hypertension during pregnancy.	early pregnancy	41 / 642	The most frequently used ARBs were candesartan (n = 76, median daily dose 16 mg) and valsartan (n = 41, median daily dose 80 mg). Treatment indication was hypertension in 97% of patients. ARBs were discontinued at the median GW 6.29 (IQR 5.0–8.14).
Hoeltzenbein 2018	Germany 2000 - 2014 prospective cohort		Prospective observational cohort study, i.e., the outcome of the evaluated pregnancies was not known at the time of case enrollment. => Exposure collected at the time of enrollment when health care professionals and patients called the service.		early pregnancy	41 / 642

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;