| 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 |
|---|
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|
|
Bonnot 2003 |
France 1976 - 1997 case control |
European Institut of Genomutations (IEG), Lyon, France. | Infants with the studied congenital malformation. | Infants with a malformations other than this one studied. | The medical records are checked to obtain data on treatment intake and other exposures or risks. | 1st trimester | -9 / -9 | Total number of infants with a congenital malformation is 13703, but the number of cases changes according to the studied malformations. Raw data not sufficient to calculate OR (data for 'control' groups not available). | |
| After having defined a population, often on geographical criteria, these networks set up birth observatories in order to exhaustively identify neonatal malformations in their reference population. | |||||||||
|
Kitchin 2022 |
Spain 2002 - 2015 case control |
The Spanish database BIFAP (Base de Datos para la Investigacion Farmacoepidemiologica en Atencion Primaria, Database for Pharmacoepidemiological Research in Primary Care). | Pregnant woman suffering a miscarriage. | Pregnant woman randomly selected from the whole cohort among women who were still at risk within follow-up, by risk-set sampling and individually matched to cases. | Database for Pharmacoepidemiological Research in Primary Care, a computerized medical longitudinal population database of electronic medical records from 10.153 primary care practitioners and pediatricians distributed on nine Autonomous Regions (out of 17), which contains prescriptions. | 1st trimester | 18070 / 54209 | Authors provided 2 exposure definitions: Use in both periods (continuers) and Use only during pregnancy (new users) => use of data for 'Use in both periods (continuers)', to decrease misclassification bais (exposure occurred before outcome). | |
| Database for Pharmacoepidemiological Research in Primary Care, a computerized medical longitudinal population database of electronic medical records from 10.153 primary care practitioners and pediatricians, which contains medical diagnoses, medical visits, hospital admissions. | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;