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 |
---|---|---|---|---|---|---|---|---|
Weber-Schoendorfer 2008 |
Finland, France, Germany, Israel, Italy, the Netherlands. 1986 - 2003 prospective cohort |
A multicenter (n = 11), prospective observational study of the European Network of Teratology Information Services (ENTIS). | Pregnant women with first- trimester exposure to Verapamil. |
unexposed (general population or NOS)
Pregnant women who had been counseled during pregnancy about exposures known to be non-teratogenic. |
at least 1st trimester | 62 / 806 | ||
A similarly structured questionnaire was used by all the centres to record the following data at the first contact during (early) pregnancy before the pregnancy outcome was known, including details of drug exposure (timing in pregnancy, dose, and duration). |
Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
---|---|---|---|---|---|---|---|---|---|
Medveczky 2004 |
Hungary 1980 - 1996 case control |
The Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). | Newborn infants (including infant deaths and usual stillborn fetuses) with Neural tube defects with non-syndromic (i.e. isolated anencephaly, spina bifida aperta/cystica, encephalocele). | Newborn infants (including infant deaths and usual stillborn fetuses) without congenital abnormalities. | Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents requesting drugs taken during pregnancy, according to gestational months; maternal prenatal care logbook (in which obstetricians must record all prescribed drugs); nurses visited non-responding families. | 1st trimester | 1202 / 38151 | Study design completed with other studies published on the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). | |
The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory (including infant deaths and usual stillborn fetuses). Controls were selected from the National Birth Registry of the Central Statistical Office. |
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;