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 |
---|---|---|---|---|---|---|---|---|
Meng a (Controls unexposed, sibling) 2023 |
Taiwan 2004 - 2018 population based cohort retrospective |
A nationwide, population-based cohort study in Taiwan using three data sources: Taiwan’s National Birth Certificate Application database, the National Health Insurance database, and the Maternal and Child Health Database. | Sibling with at least one Midazolam prescription received by the mother during early pregnancy (the first 20 weeks of pregnancy). |
sibling
Discordant matched sibling without benzodiazepine or Z-hypnotic prescriptions from 30 days before the date of the estimated last menstrual period to the end of the 20th week of pregnancy. |
early pregnancy | -9 / -9 | Number of exposures not provided (authors provided number of Exposure discordant pairs and number of Case discordant pairs). | |
The National Health Insurance (NHI) database that comprises anonymised health insurance claims for visits, procedures, and prescriptions for more than 99% of the population in Taiwan (about 23 million). | ||||||||
Meng a (Controls unexposed, sick) 2023 |
Taiwan 2004 - 2018 population based cohort retrospective |
A nationwide, population-based cohort study in Taiwan using three data sources: Taiwan’s National Birth Certificate Application database, the National Health Insurance database, and the Maternal and Child Health Database. | At least one Midazolam prescription received by a mother during early pregnancy (the first 20 weeks of pregnancy). |
unexposed, sick
Pregnant women with no benzodiazepine or Z-hypnotic prescriptions from 30 days before the date of the estimated last menstrual period to the end of the 20th week of pregnancy. |
early pregnancy | 1317 / 2763341 | Use of results obtained with PS-FSW because more exposures, with a sick control group and sensitivity analyses (sibling control study, and paternal negative control design) that obtained similar results. | |
The National Health Insurance (NHI) database that comprises anonymised health insurance claims for visits, procedures, and prescriptions for more than 99% of the population in Taiwan (about 23 million). | ||||||||
Noh 2022 |
South Korea 2011 - 2018 population based cohort retrospective |
A nationwide retrospective cohort study using healthcare data retrieved from the Health Insurance Review and Assessment Service (HIRA) database. | Pregnant women who filled at least Midazolam prescription during the first trimester (first 90 days of pregnancy). |
unexposed, sick
Pregnant women who were not prescribed any benzodiazepine from 3 months before the last menstrual period to the end of the first trimester (with similar psychiatric conditions after propensity score). |
1st trimester | 8609 / 3053381 | Propensity scored adjusted for indications and led to an unexposed cohort with similar psychiatric conditions => considered as unexposed, sick control groups. | |
The Health Insurance Review and Assessment Service (HIRA) database that comprises notably healthcare utilization (e.g., drug prescription and medical procedure). |
Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
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Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;