Clobazam (Epilepsy) - Medication and Pregnancy KB

Clobazam (Epilepsy)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Battino (Epilepsy), 2024	Worldwide (47 countries) 1999 - 2022	Pregnant women with epilepsy exposed to antiseizure medications at the time of conception and enrolled within the 16th week of gestation, where fetal outcome had not yet been determined.	Pregnant women with epilepsy exposed to Clobazam monotherapy at the time of conception.	exposed to other treatment, sick Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.	19 / 3584	Overlapping: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016), Tomson 2011 and Jimenez 2020 (1 center in Spain 2000-2018) => Use of Battino 2024 for the 8 (plus 16 in eSupp) ASM monotherapies studied here.
Christensen (Epilepsy) (Controls exposed to LTG), 2024	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017	All live-born singletons born of women with epilepsy in the included countries during the study periods.	Children of mothers with 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).	exposed to other treatment, sick Children of mothers who had redeemed at least one prescription of Lamotrigine monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period).	27 / 5299	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
Christensen (Epilepsy) (Controls unexposed, general population), 2024	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017	All live-born singletons born of women with epilepsy in the included countries during the study periods.	Children of mothers with 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, sick Children of mothers with epilepsy who had not redeemed prescription of anti-seizure medication.	27 / 22227	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
Hvas (Epilepsy) (Controls unexposed, disease free), 2000	Denmark 1989 - 1997	Singleton pregnancies in Danish-speaking women who attended for antenatal care and delivered at Aarhus University Hospital during the study period. All women who reported chronic disease other than epilepsy were excluded.	Children of women with epilepsy exposed to clobazam monotherapy during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Children of women without chronic disease.	1 / 24094
Hvas (Epilepsy) (Controls unexposed, sick), 2000	Denmark 1989 - 1997	Singleton pregnancies in Danish-speaking women who attended for antenatal care and delivered at Aarhus University Hospital during the study period. All women who reported chronic disease other than epilepsy were excluded.	Children of women with epilepsy exposed to clobazam monotherapy during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children of women with epilepsy without treatment.	1 / 106
Kini (Epilepsy) (Controls exposed to Lamotrigine, sick), 2007	United Kingdom 2000 - 2004	Women with epilepsy were recruited to the study by the research nurses at the time of booking for antenatal care from the study centers.	Children of epileptic mothers taking clobazam monotherapy during the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children of epileptic mothers taking lamotrigine monotherapy during the pregnancy.	1 / 15	Details on the exposition measure were obtained from the publication of Mawer 2010.
Kini (Epilepsy) (Controls unexposed, disease free), 2007	United Kingdom 2000 - 2004	Women with epilepsy were recruited to the study by the research nurses at the time of booking for antenatal care from the study centers.	Children of epileptic mothers taking clobazam monotherapy during the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Children of mothers without epilepsy recruited at the same time.	1 / 236	Details on the exposition measure were obtained from the publication of Mawer 2010.
Kini (Epilepsy) (Controls unexposed, sick), 2007	United Kingdom 2000 - 2004	Women with epilepsy were recruited to the study by the research nurses at the time of booking for antenatal care from the study centers.	Children of epileptic mothers taking clobazam monotherapy during the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children of epileptic mothers who were not exposed to any antiepileptic drugs during pregnancy.	1 / 34	Details on the exposition measure were obtained from the publication of Mawer 2010.
Thomas (Epilepsy) (Controls exposed to Lamotrigine, sick), 2021	India 1998 - 2019	All pregnancies with known outcomes in women with epilepsy enrolled in the registry during 1998 - 2013 and the diagnosis of epilepsy was confirmed before registration.	Children of women with epilepsy using clobazam monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children of women with epilepsy using lamotrigine monotherapy any time during the first trimester of pregnancy.	14 / 50	Study design completed with Thomas et al., 2017. Keni's 2018 malformations results are already reported in this publication.
Thomas (Epilepsy) (Controls exposed to LTG), 2022	India 1998 - 2019	All babies of women with epilepsy (WWE) enrolled in the pre-pregnancy stage or in the first trimester of pregnancy, who were over 12 months of age on 31st December, 2020 (and less than 24 months).	Infants of women with epilepsy who were exposed to Clobazam monotherapy at anytime during the antenatal period.	exposed to other treatment, sick Infants of women with epilepsy who were exposed to Lamotrigine monotherapy at anytime during the antenatal period.	7 / 26	No use of delayed mental development, because discrepancy in LTG data '1/26 (11.5%)'.
Thomas (Epilepsy) (Controls unexposed, sick), 2021	India 1998 - 2019	All pregnancies with known outcomes in women with epilepsy enrolled in the registry during 1998 - 2013 and the diagnosis of epilepsy was confirmed before registration.	Children of women with epilepsy using clobazam monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children of women with epilepsy not using any antiepileptic drugs during the first trimester.	14 / 340	Study design completed with Thomas et al., 2017.
Thomas (Epilepsy) (Controls unexposed, sick), 2022	India 1998 - 2019	All babies of women with epilepsy (WWE) enrolled in the pre-pregnancy stage or in the first trimester of pregnancy, who were over 12 months of age on 31st December, 2020 (and less than 24 months).	Infants of women with epilepsy who were exposed to Clobazam monotherapy at anytime during the antenatal period.	unexposed, sick Infants of women with epilepsy who were not exposed to any antiseizure medications (ASMs) during pregnancy.	7 / 110
Trivedi (Epilepsy) (Controls exposed to Lamotrigine, sick), 2018	India 1998 - 2015	All women with epilepsy who had completed their pregnancies and enrolled in the registry between the study period. The diagnosis of epilepsy was confirmed before registration.	Pregnant women with epilepsy who used clobazam monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Pregnant women with epilepsy who used lamotrigine monotherapy any time during the first trimester of pregnancy.	11 / 48	Study design partly completed with cites source Thomas et al., 2017.
Trivedi (Epilepsy) (Controls unexposed, sick), 2018	India 1998 - 2015	All women with epilepsy who had completed their pregnancies and enrolled in the registry between the study period. The diagnosis of epilepsy was confirmed before registration.	Pregnant women with epilepsy who used clobazam monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Pregnant women with epilepsy who were not on antiepileptic drug during their first trimester.	11 / 178	Study design partly completed with cites source Thomas et al., 2017.
Vajda (Epilepsy) (Controls exposed to Lamotrigine, sick), 2019	Australia 1999 - 2018	Pregnant women taking antiepileptic drugs for any indications or not treated with antiepileptic drugs in at least the first half of pregnancy.	Offsprings born from women nearly always with epilepsy exposed to clobazam in monotherapy in at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Offsprings born from women nearly always with epilepsy exposed to lamotrigine in monotherapy in at least the first trimester of pregnancy.	2 / 406	Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013.
Vajda (Epilepsy) (Controls unexposed, sick), 2019	Australia 1999 - 2018	Pregnant women taking antiepileptic drugs for any indications or not treated with antiepileptic drugs in at least the first half of pregnancy.	Offsprings born from women nearly always with epilepsy exposed to clobazam in monotherapy in at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Offsprings born from women nearly always with epilepsy not treated with antiepileptic drugs in at least the first half of pregnancy.	2 / 176	Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

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