Fludiazepam - Medication and Pregnancy KB

Fludiazepam

Exposed non-exposed, cohort studies

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 Fludiazepam 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).
Meng a (Controls unexposed, sibling) 2023	Taiwan 2004 - 2018 population based cohort retrospective		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).		early pregnancy	-9 / -9
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 Fludiazepam 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	6935 / 2763896	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.
Meng a (Controls unexposed, sick) 2023	Taiwan 2004 - 2018 population based cohort retrospective		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).		early pregnancy	6935 / 2763896
Meng b 2023	Taiwan 2004 - 2018 other	The Taiwan’s National Birth Certificate Application database and the National Health Insurance database.	Women receiving at least 1 prescription of Fludiazepam during the risk period only (1-28 days before miscarriage).	unexposed, sick Women receiving at least 1 prescription of Fludiazepam during the reference period only (181-208 days before the last menstrual period).	during pregnancy (anytime or not specified)	136134 / 134864	Use of Case-Time-Control (CTC) Design OR => nb of exposures/cases/controls not applicable; and the main Reference period, i.e 181 to 208 days before the last menstrual period.
Meng b 2023	Taiwan 2004 - 2018 other		The National Health Insurance (NHI) database that comprises anonymized prescriptions for more than 99% of the population in Taiwan.		during pregnancy (anytime or not specified)	136134 / 134864

Case-control studies

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;

Empty. There are no case-control studies available for this drug.

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