Study Type of data Exposure measurement Outcome assessment Adjustment
Medveczky, 2004 case control 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. 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. Controls matched according to sex, birth week, and district of parents' residence. Multivariable unconditional logistic regression model for maternal age, birth order, and employment status.
Weber-Schoendorfer, 2008 prospective cohort 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). Follow-up was conducted by mailed questionnaire or by a telephone interview with the woman and/or her physician and/or the pediatrician of the infant. Pregnancy outcome, gestational age at birth, birth weight, birth defects and postnatal disorders were obtained. No adjustment for this group of exposure.

master protocol