Clobazam (Psy and Mixed indications) - Medication and Pregnancy KB

Clobazam (Psy and Mixed indications)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Christensen (Indications other than epilepsy), 2024	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017	All live-born singletons born of women without epilepsy in the included countries during the study periods.	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.	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).
Kilic (Mixed indications), 2014	Denmark 1997 - 2008	All singleton live-born children in Denmark during the study period.	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.	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).
Noh (Indications NOS), 2022	South Korea 2011 - 2018	All pregnancies in women aged 20 to 45 years at delivery resulting in live births from 1 January 2011 to 31 December 2018, in South Korea.	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).	218 / 3053381	Propensity scored adjusted for indications and led to an unexposed cohort with similar psychiatric conditions => considered as unexposed, sick control groups.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

master protocol