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 |
---|---|---|---|---|---|---|---|---|
Colvin 2010 |
Australia 2002 - 2005 retrospective cohort (claims database) |
Linkage between administrative records of medicines dispensed in pregnancy (Pharmaceutical Benefits Scheme (PBS) and health administrative data. | Perindopril erbumine dispensed from 14 days after the last menstrual period (LMP) to the end of first trimester or to the end of the pregnancy event. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
All other births (those births to women dispensed a Pharmaceutical Benefits Scheme (PBS) medicine or not). |
1st trimester | 32 / 106042 | Category D or X medicines also studied. Total nb of unexposed: 106042=106074-32. Birth defect: structural or functional abnormality. Most minor defects are not recorded in the BDR. Of all cases, about 90% have at least one major birth defect. | |
The national Pharmaceutical Benefits Scheme, with around 80% of prescriptions dispensed in Australia. |
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;