| 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 |
|---|---|---|---|---|---|---|---|---|
|
Christensen (Indications other than epilepsy) 2024 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 population based cohort retrospective |
Nordic population-based cohort study including register data from Denmark, Finland, Iceland, Norway, and Sweden–the SCAN-AED project. | Children of mothers without epilepsy who had redeemed at least one prescription of Clobazam monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period). |
unexposed (general population or NOS)
Children of mothers without epilepsy who had not redeemed prescription of anti-seizure medication. |
during pregnancy (anytime or not specified) | 17 / 4445621 | Considering the indication of this meta-analysis: use 'Indications other than epilepsy'. OR for LBW and SGA cannot be calculated due to censured values (<5). | |
| Prenatal exposure was identified via national prescription registers. These registers contain the Anatomical Therapeutic Chemical (ATC) classification code (www.whocc.no) and the date of dispensing. | ||||||||
|
Kilic (Mixed indications) 2014 |
Denmark 1997 - 2008 population based cohort retrospective |
The Danish Medical Birth Registry, the Danish Civil Registration System, the Danish National Hospital Registry, and the Danish Register of Medicinal Product Statistics. | Children whose mothers have been exposed to clobazam in (antiepileptic) monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Children whose mothers haven't been exposed to antiepileptic drugs 30 days before the estimated day of conception to the day of birth. |
during pregnancy (anytime or not specified) | 30 / 676834 | Less than 90% of women are epileptic. For Low birth weight: High discrepancy between raw data and unadjusted RR. => not reported here (mail sent to authors the 7 april 2025). | |
| The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes. | ||||||||
|
Noh (Indications NOS) 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 Clobazam 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 | 218 / 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 |
|---|
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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