Clobazam (Epilepsy)

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
Battino (Epilepsy)
2024 		Worldwide (47 countries)
1999 - 2022
prospective cohort 		The International Registry of Antiepileptic Drugs and Pregnancy (EURAP). 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. 		early pregnancy 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.
Reporting physicians collected information on drug therapy after each trimester.
Christensen (Epilepsy) (Controls exposed to LTG)
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 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). 		during pregnancy (anytime or not specified) 27 / 5299 Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
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.
Christensen (Epilepsy) (Controls unexposed, general population)
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 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. 		during pregnancy (anytime or not specified) 27 / 22227 Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
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.
Hvas (Epilepsy) (Controls unexposed, disease free)
2000 		Denmark
1989 - 1997
prospective cohort 		Department of Obstetrics and Gynaecology at Aarhus University Hospital. 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. 		1st trimester 1 / 24094
Women completed a questionnaire. They were categorised as users or nonusers of anticonvulsant drugs, by self-reported daily intake of any anticonvulsant drug during the first trimester.
Hvas (Epilepsy) (Controls unexposed, sick)
2000 		Denmark
1989 - 1997
prospective cohort 		Department of Obstetrics and Gynaecology at Aarhus University Hospital. 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. 		1st trimester 1 / 106
Women completed a questionnaire. They were categorised as users or nonusers of anticonvulsant drugs, by self-reported daily intake of any anticonvulsant drug during the first trimester.
Kini (Epilepsy) (Controls exposed to Lamotrigine, sick)
2007 		United Kingdom
2000 - 2004
prospective cohort 		4 centres within the Manchester area and 7 centres in the Cheshire and Merseyside regions, United Kingdom. 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. 		during pregnancy (anytime or not specified) 1 / 15 Details on the exposition measure were obtained from the publication of Mawer 2010.
The research nurse took a personal and medical history in accordance with the prospectively designed Patient Basic and Control Basic Record Forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records.
Kini (Epilepsy) (Controls unexposed, disease free)
2007 		United Kingdom
2000 - 2004
prospective cohort 		4 centres within the Manchester area and 7 centres in the Cheshire and Merseyside regions, United Kingdom. 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. 		during pregnancy (anytime or not specified) 1 / 236 Details on the exposition measure were obtained from the publication of Mawer 2010.
The research nurse took a personal and medical history in accordance with the prospectively designed Patient Basic and Control Basic Record Forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records.
Kini (Epilepsy) (Controls unexposed, sick)
2007 		United Kingdom
2000 - 2004
prospective cohort 		4 centres within the Manchester area and 7 centres in the Cheshire and Merseyside regions, United Kingdom. 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. 		during pregnancy (anytime or not specified) 1 / 34 Details on the exposition measure were obtained from the publication of Mawer 2010.
The research nurse took a personal and medical history in accordance with the prospectively designed Patient Basic and Control Basic Record Forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records.
Thomas (Epilepsy) (Controls exposed to Lamotrigine, sick)
2021 		India
1998 - 2019
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) 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. 		1st trimester 14 / 50 Study design completed with Thomas et al., 2017. Keni's 2018 malformations results are already reported in this publication.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
Thomas (Epilepsy) (Controls exposed to LTG)
2022 		India
1998 - 2019
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP), India. 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. 		during pregnancy (anytime or not specified) 7 / 26 No use of delayed mental development, because discrepancy in LTG data '1/26 (11.5%)'.
Each pregnant woman in the Kerala Registry of Epilepsy and Pregnancy (KREP) maintained a pregnancy diary to record the daily use of antiseizure medications (ASMs). Data were then transferred to the clinical records of the registry during their clinic visits.
Thomas (Epilepsy) (Controls unexposed, sick)
2022 		India
1998 - 2019
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP), India. 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. 		during pregnancy (anytime or not specified) 7 / 110
Each pregnant woman in the Kerala Registry of Epilepsy and Pregnancy (KREP) maintained a pregnancy diary to record the daily use of antiseizure medications (ASMs). Data were then transferred to the clinical records of the registry during their clinic visits.
Thomas (Epilepsy) (Controls unexposed, sick)
2021 		India
1998 - 2019
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) 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. 		1st trimester 14 / 340 Study design completed with Thomas et al., 2017.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
Trivedi (Epilepsy) (Controls exposed to Lamotrigine, sick)
2018 		India
1998 - 2015
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) 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. 		1st trimester 11 / 48 Study design partly completed with cites source Thomas et al., 2017.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
Trivedi (Epilepsy) (Controls unexposed, sick)
2018 		India
1998 - 2015
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP), India. 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. 		1st trimester 11 / 178 Study design partly completed with cites source Thomas et al., 2017.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
Vajda (Epilepsy) (Controls exposed to Lamotrigine, sick)
2019 		Australia
1999 - 2018
prospective cohort 		The Australian Register of Antiepileptic Drugs in 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. 		at least 1st trimester 2 / 406 Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013.
Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records.
Vajda (Epilepsy) (Controls unexposed, sick)
2019 		Australia
1999 - 2018
prospective cohort 		The Australian Register of Antiepileptic Drugs in 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. 		at least 1st trimester 2 / 176 Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013.
Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records.

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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