Clobazam (Epilepsy) updated on 02-10-2025

Major congenital malformations

id	Study   Auto Battino (Epilepsy), 2024Thomas (Epilepsy) (Controls exposed to Lamotrigine, sick), 2021Thomas (Epilepsy) (Controls unexposed, sick), 2021Vajda (Epilepsy) (Controls exposed to Lamotrigine, sick), 2019Vajda (Epilepsy) (Controls unexposed, sick), 2019Kini (Epilepsy) (Controls exposed to Lamotrigine, sick), 2007Kini (Epilepsy) (Controls unexposed, disease free), 2007Kini (Epilepsy) (Controls unexposed, sick), 2007Hvas (Epilepsy) (Controls unexposed, disease free), 2000Hvas (Epilepsy) (Controls unexposed, sick), 2000	Lib. in paper	Exposition period  Auto during pregnancy (anytime or not specified)1st trimester2nd trimester3rd trimester2nd and/or 3rd trimesterthroughout pregnancyearly pregnancydays before deliverylate pregnancypreconception-onlypericonceptionalpreconceptional for kinetic reasonat least 1st trimester3 months (or more) before pregnancy or during pregnancy1st and 2nd trimester3 months or more before pregnancy or1st trimester	Study type  All studies Case control excluded Only case control	Control type    Auto unexposed (general population or NOS)unexposed, sickunexposed, disease freeexposed to other treatment, sicknot specifiedsiblingwhatever (meta-analysis)	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S16577 R69635	Battino (Epilepsy), 2024	Major congenital malformations (MCMs)	early pregnancy	prospective cohort	exposed to other treatment, sick	Adjustment: No	1.75 [0.23;13.26] C	1/19   110/3,584	111	19		ref
S12866 R48559	Thomas (Epilepsy) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	13.36 [1.27;140.94] C excluded (control group)	3/14   1/50	4	14		ref
S12867 R48569	Thomas (Epilepsy) (Controls unexposed, sick), 2021	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	5.52 [1.40;21.77] C	3/14   16/340	19	14		ref
S7790 R23008	Vajda (Epilepsy) (Controls exposed to Lamotrigine, sick), 2019	Fetal malformations	at least 1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	6.27 [0.25;158.67] C excluded (control group)	0/2   20/406	20	2		ref
S7791 R23009	Vajda (Epilepsy) (Controls unexposed, sick), 2019	Fetal malformations	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	10.33 [0.38;283.37] C	0/2   5/176	5	2		ref
S6649 R18355	Kini (Epilepsy) (Controls exposed to Lamotrigine, sick), 2007	Major malformations	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	29.00 [0.23;3625.72] C excluded (control group)	0/1   0/15	0	1		ref
S6639 R18345	Kini (Epilepsy) (Controls unexposed, disease free), 2007	Major malformations	during pregnancy (anytime or not specified)	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	41.91 [0.76;2311.57] C excluded (control group)	0/1   5/236	5	1		ref
S6644 R18350	Kini (Epilepsy) (Controls unexposed, sick), 2007	Major malformations	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	67.00 [0.54;8247.13] C excluded (exposition period)	0/1   0/34	0	1		ref
S8390 R26547	Hvas (Epilepsy) (Controls unexposed, disease free), 2000	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No	83.94 [1.66;4238.34] C excluded (control group)	0/1   280/23,827	280	1		ref
S8391 R26548	Hvas (Epilepsy) (Controls unexposed, sick), 2000	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	211.00 [1.73;25761.82] C	0/1   0/106	0	1		ref
					Total	4 studies	5.36 [1.56;18.43]		135	36
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

Sensitivity analysis

Publication bias and p-hacking diagnosis

Sub-groups analysis using all included studies

excluded 8390, 6649, 6639, 7790, 12866