Study Type of data Exposure measurement Outcome assessment Adjustment
Bortolus, 2000 randomized controlled trial Eligible women were randomly assigned treatment group. Group allocation was done by telephone to the Istituto Mario Negri in Bergamo. The randomisation list was generated by computer. Separate randomisation lists were used for each centre and type of hypertension. A postal questionnaire was sent to the parents which asked about the child‘s general health, height, weight, malformations, respiratory, hearing, and vision problems, and other major disorders. Other questions concerned the child’s gross and fine motor and language development. No adjustment. Randomisation. Exclusion of women history of chronic diseases such as diabetes or renal disease, documented fetal malformations, antihypertensive treatment if not interrupted before the eighth week of gestation.
Parazzini, 1998 randomized controlled trial Eligible women were randomly assigned treatment group. Group allocation was done by telephone to the Istituto Mario Negri in Bergamo. The randomisation list was generated by computer. Separate randomisation lists were used for each centre and type of hypertension. Two ultrasound examinations (before 20 weeks of gestation and between 28 and 34 weeks) were performed to check fetal growth. The clinical data were collected prospectively during pregnancy and were sent to the coordinating centre, together with the outcome of pregnancy and the infant’s condition. No adjustment. Randomisation. Exclusion of women history of chronic diseases such as diabetes or renal disease, documented fetal malformations, antihypertensive treatment if not interrupted before the eighth week of gestation.
Vermes, 2015 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 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.
Zarante, 2009 case control Information collected in 10 Colombian hospitals (NOS). Information collected in 10 Colombian hospitals (NOS). No match/adjustment for this group of exposure. No significant differences between both groups in terms of maternal age, birth weight and gestational age.

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