Isradipine (versus unexposed) - Medication and Pregnancy KB

Isradipine (versus unexposed)

Exposed non-exposed, cohort studies

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
Darcie 2004	Brazil 1994 - 1997 prospective cohort	A randomized, longitudinal, prospective study conducting at the Neonatal Pediatrics Service, Faculty of Medicine, University of São Paulo.	Newborns of hypertensive mothers treated with isradipine (5 mg twice a day) for at least 2 weeks before the delivery.	unexposed, sick Newborns of hypertensive mothers whose hypertension was controlled with diet only (without antihypertensive medication), for a minimum period of 2 weeks.	late pregnancy	39 / 14	Study considered as a prospective cohort because no precision indicating that a randomization was carried out.
Darcie 2004	Brazil 1994 - 1997 prospective cohort		This was a randomized, longitudinal, prospective study comparing 3 groups of patients according to the type of maternal treatment. => Not otherwise specified => Considered as a prospective cohort because no precision indicating that a randomization was carried out.		late pregnancy	39 / 14
Wide-Swensson 1995	Denmark and Sweden Not specified. randomized controlled trial	A double-blind randomized controlled trial conducted at five centers in Sweden and one in Denmark (University hospital of Lund, Karolinska Institute, University hospital Arhus, University hospital of Uppsala, Hospital of Orebro and Malmo hospital).	Women with hypertension in pregnancy randomized to capsules of oral slow-release isradipine 5 mg twice daily.	unexposed, sick Women with hypertension in pregnancy randomized to capsules of placebo given twice daily.	3rd trimester	54 / 57	Data related to Apgar scores not reported because the number of available data for the 2 groups not provided by authors.
Wide-Swensson 1995			The patients were randomized by numbers. The randomization was done in blocks of 6 patients. Information as to which treatment each woman was given was stored in a sealed envelope, which was not opened until the study was completed.		3rd trimester	54 / 57

Case-control studies

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;

Empty. There are no case-control studies available for this drug.

master protocol