Oxcarbazepine (All indications)

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
AlSheikh (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2020 		Saudi Arabia
2018 - 2019
prospective cohort 		King Fahd University Hospital Fetuses/neonates of patients with active epilepsy who received oxcarbazepine monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Fetuses/neonates of patients with active epilepsy who received lamotrigine monotherapy during pregnancy. 		during pregnancy (anytime or not specified) 3 / 20
Information was collected through a structured questionnaire ‘Questionnaire for Investigation of Epilepsy in Tropical Countries'.
AlSheikh (Oxcarbazepine) (Controls unexposed, sick)
2020 		Saudi Arabia
2018 - 2019
prospective cohort 		King Fahd University Hospital Fetuses/neonates of patients with active epilepsy who received oxcarbazepine monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Fetuses/neonates of patients with active epilepsy who did not take antiepileptic drugs during pregnancy. 		during pregnancy (anytime or not specified) 3 / 8
Information was collected through a structured questionnaire ‘Questionnaire for Investigation of Epilepsy in Tropical Countries'.
Artama (Oxcarbazepine)
2005 		Finland
1991 - 2000
retrospective cohort (registry) 		The Medical Birth Register and the Social Insurance Institution (SII) of Finland. Children whose epileptic mothers were exposed to oxcarbazepine as 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 whose epileptic mothers were untreated during the first trimester of pregnancy. 		1st trimester 99 / 939
Information on the antiepileptic drugs received during pregnancy was abstracted from medical records of the mothers with epilepsy.
Artama (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2013 		Finland
1996 - 2008
population based cohort retrospective 		The Medical Birth Register (MBR), the Finnish Malformation Register, the Special Refund Entitlement Register, the Register on Reimbursement Drugs and Cause-of-Death Register. Births in pregnant women with epilepsy exposed to oxcarbazepine in monotherapy 1 month prior to pregnancy and/or any time during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Births in pregnant women with epilepsy exposed to lamotrigine in monotherapy 1 month prior to pregnancy and/or any time during pregnancy. 		3rd trimester, during pregnancy (anytime or not specified) 532 / 173 Overlapping: For LBW and SGA: Artama 2013 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes.
The Special Refund Entitlement Register and the Register on Reimbursement Drugs contained informations on maternal drug treatment under ATC category N03.
Artama (Oxcarbazepine) (Controls unexposed, disease free)
2013 		Finland
1996 - 2008
population based cohort retrospective 		The Medical Birth Register (MBR), the Finnish Malformation Register, the Special Refund Entitlement Register, the Register on Reimbursement Drugs and Cause-of-Death Register. Births in pregnant women with epilepsy exposed to oxcarbazepine in monotherapy 1 month prior to pregnancy and/or any time during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Births in pregnant women without epilepsy and unexposed to any antiepileptic drugs 1 month prior to pregnancy and/or any time during pregnancy. 		3rd trimester, during pregnancy (anytime or not specified) 532 / 721948 Overlapping: For LBW and SGA: Artama 2013 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes.
The Special Refund Entitlement Register and the Register on Reimbursement Drugs contained informations on maternal drug treatment under ATC category N03.
Artama (Oxcarbazepine) (Controls unexposed, sick)
2013 		Finland
1996 - 2008
population based cohort retrospective 		The Medical Birth Register (MBR), the Finnish Malformation Register, the Special Refund Entitlement Register, the Register on Reimbursement Drugs and Cause-of-Death Register. Births in pregnant women with epilepsy exposed to oxcarbazepine in monotherapy 1 month prior to pregnancy and/or any time during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Births in pregnant women with epilepsy and unexposed to any antiepileptic drugs 1 month prior to pregnancy and/or any time during pregnancy. 		3rd trimester, during pregnancy (anytime or not specified) 532 / 1800 Overlapping: For LBW and SGA: Artama 2013 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes.
The Special Refund Entitlement Register and the Register on Reimbursement Drugs contained informations on maternal drug treatment under ATC category N03.
Aydin (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2020 		Turkey
2007 - 2017
retrospective cohort 		The Division of Perinatology, Department of Obstetrics and Gynecology, Hacettepe University Pregnant women with epilepsy who received oxcarbazepine in monotherapy during 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 received lamotrigine in monotherapy during pregnancy. 		throughout pregnancy 4 / 7 There were no patients who had drug changes or discontinued during pregnancy.
Data were obtained from Perinatology Division’s computerized system. Antiepileptic drug use were reported.
Aydin (Oxcarbazepine) (Controls unexposed, sick)
2020 		Turkey
2007 - 2017
retrospective cohort 		The Division of Perinatology, Department of Obstetrics and Gynecology, Hacettepe University Pregnant women with epilepsy who received oxcarbazepine in monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Pregnant women with epilepsy with no antiepileptic drugs during pregnancy. 		throughout pregnancy 4 / 22 There were no patients who had drug changes or discontinued during pregnancy.
Data were obtained from Perinatology Division’s computerized system. Antiepileptic drug use were reported.
Bank (Oxcarbazepine) (Mixed indications)
2017 		USA
2002 - 2006
prospective cohort 		Emory Women’s Epilepsy and Mental Health Programs Singleton pregnancies in mothers taking oxcarbazepine monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Singleton pregnancies in mothers taking lamotrigine monotherapy during pregnancy. 		during pregnancy (anytime or not specified) 4 / 36
Medical records were obtained for review from the treating obstetrician, the delivery hospital, and the treating pediatrician. Umbilical cord and maternal venous blood were collected to measure total anti-epileptic levels by liquid chromatography/mass spectrometry.
Battino (Oxcarbazepine) (Epilepsy)
2024 		Worldwide (47 countries)
1999 - 2022
prospective cohort 		The International Registry of Antiepileptic Drugs and Pregnancy (EURAP). Pregnant women with epilepsy exposed to Oxcarbazepine 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 443 / 3584 Overlapping/Update: (Major) malfo as a whole: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) and Tomson 2011 => Use of Battino 2024 for the 8 (plus 16 in eSupp) monotherapies studied.
Reporting physicians collected information on drug therapy after each trimester.
Bech (Oxcarbazepine) (Mixed indications)
2018 		Denmark
2005 - 2008
population based cohort propective 		The Danish Prescription Register, the Danish Medical Birth Register, the Danish Psychiatric Central Research Register and Danish National Patient Registry. Singleton offspring of mothers exposed to oxcarbazepine monotherapy within 90 days prior to conception to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Singleton offspring of mothers exposed to antiepileptic drugs at any time but not during pregnancy. 		during pregnancy (anytime or not specified) 44 / 434
The Danish National Prescription Register was used to obtain data on redeemed prescriptions using Anatomical Therapeutic Chemical (ATC) codes.
Bjørk (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2022 		Danemark, Finland, Iceland, Norway and Sweden.
1996 - 2017
population based cohort retrospective 		Social register data from Danemark, Finland, Iceland, Norway, Sweden for SCAN-AED: Nordic register-based study of antiepileptic drugs in pregnancy. Pregnacies in epileptic mothers (>90%) filling at least one oxcarbazepine monotherapy prescription from her last menstrual period until birth. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Pregnacies in epileptic mothers filling at least one lamotrigine monotherapy prescription from her last menstrual period until birth. 		during pregnancy (anytime or not specified) 1539 / 5073 Overlapping between Daugaard 2020, Dreier 2023 and Bjork 2022 for Intellectual disabilities (2 outcomes), and Christensen 2013, Dreier and Bjork for ASD (2 outcomes) with more pregnancies in Bjork 2022 => use of Bjork 2022 data.
Prescriptions through national prescription registers according to Anatomical Therapeutic Chemical classification codes N03, N05BA09, and S01EC01.
Bjørk (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2018 		Norway
1999 - 2008
population based cohort propective 		The Norwegian Mother and Child Cohort Study (MoBa) and The Medical Birth Registry of Norway. Children of women with reported epilepsy and oxcarbazepine monotherapy use during 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 reported epilepsy and lamotrigine monotherapy use during pregnancy. 		during pregnancy (anytime or not specified) 9 / 104
Information on anti-epileptics use was obtained from the questionnaires completed by mothers during gestational weeks 17 to 19 (Q1) and 30 (Q2); and through the Medical Birth Registry of Norway.
Bjørk (Oxcarbazepine) (Controls unexposed NOS)
2022 		Danemark, Finland, Iceland, Norway and Sweden.
1996 - 2017
population based cohort retrospective 		Social register data from Danemark, Finland, Iceland, Norway, Sweden for SCAN-AED: Nordic register-based study of antiepileptic drugs in pregnancy. Pregnancies in epileptic mothers (>90%) filling at least one oxcarbazepine monotherapy prescription from her last menstrual period until birth. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Pregnancies in mothers without antiseizure medication prescription from her last menstrual period until birth. 		during pregnancy (anytime or not specified) 1539 / 4463879 Overlapping between Daugaard 2020, Dreier 2023 and Bjork 2022 for Intellectual disabilities (2 outcomes), and Christensen 2013, Dreier and Bjork for ASD (2 outcomes) with more pregnancies in Bjork 2022 => use of Bjork 2022 data.
Prescriptions through national prescription registers according to Anatomical Therapeutic Chemical classification codes N03, N05BA09, and S01EC01.
Bjørk (Oxcarbazepine) (Controls unexposed, disease free)
2018 		Norway
1999 - 2008
population based cohort propective 		The Norwegian Mother and Child Cohort Study (MoBa) and The Medical Birth Registry of Norway. Children of women with reported epilepsy and oxcarbazepine monotherapy use during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
All children of mothers without reported epilepsy unexposed to antiepileptic drugs during pregnancy. 		during pregnancy (anytime or not specified) 9 / 104222
Information on anti-epileptics use was obtained from the questionnaires completed by mothers during gestational weeks 17 to 19 (Q1) and 30 (Q2); and through the Medical Birth Registry of Norway.
Bjørk (Oxcarbazepine) (Controls unexposed, sick)
2022 		Danemark, Finland, Iceland, Norway and Sweden.
1996 - 2017
population based cohort retrospective 		Social register data from Danemark, Finland, Iceland, Norway, Sweden for SCAN-AED: Nordic register-based study of antiepileptic drugs in pregnancy. Pregnancies in epileptic mothers filling at least one oxcarbazepine monotherapy prescription from her last menstrual period until birth. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Pregnancies in epileptic mothers without antiseizure medication prescription from her last menstrual period until birth. 		during pregnancy (anytime or not specified) 1429 / 21634 Overlapping between Daugaard 2020, Dreier 2023 and Bjork 2022 for Intellectual disabilities (2 outcomes), and Christensen 2013, Dreier and Bjork for ASD (2 outcomes) with more pregnancies in Bjork 2022 => use of Bjork 2022 data.
Prescriptions through national prescription registers according to Anatomical Therapeutic Chemical classification codes N03, N05BA09, and S01EC01.
Bjørk (Oxcarbazepine) (Controls unexposed, sick)
2018 		Norway
1999 - 2008
population based cohort propective 		The Norwegian Mother and Child Cohort Study (MoBa) and The Medical Birth Registry of Norway. Children of women with reported epilepsy and oxcarbazepine monotherapy use during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Children of women with reported epilepsy but no antiepileptic drug intake during pregnancy. 		during pregnancy (anytime or not specified) 9 / 389 In this control group 127 (70.9%) reported inactive epilepsy defined as not using AEDs during the 2 years before conception or no seizures during the previous 5 years.
Information on anti-epileptics use was obtained from the questionnaires completed by mothers during gestational weeks 17 to 19 (Q1) and 30 (Q2); and through the Medical Birth Registry of Norway.
Blotière (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications)
2019 		France
2011 - 2015
retrospective cohort (claims database) 		The French national health insurance database (DCIR) and the French hospital discharge database (PMSI). Pregnancies exposed to oxcarbazepine monotherapy between 1 month before and 2 months after the beginning of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Pregnancies exposed to lamotrigine monotherapy between 1 month before and 2 months after the beginning of pregnancy. 		1st trimester 139 / 2997 Authors excluded twin pregnancies and pregnancies with a chromosomal abnormality identified. Less than 90% of exposed pregnancies have a proxy for epilepsy. Publication's OR were not kept when lower limit of the confidence interval or OR equal to 0.
The French national health insurance database contains all health care claims reimbursed by French National Health Insurance. Include dispensed drugs coded according to the ATC classification. Monotherapy was defined as the absence of any other antiepileptic drug dispensed during the same period.
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications)
2019 		France
2011 - 2015
retrospective cohort (claims database) 		The French national health insurance database (DCIR) and the French hospital discharge database (PMSI). Pregnancies exposed to oxcarbazepine monotherapy between 1 month before and 2 months after the beginning of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Pregnancies with no reimbursement for antiepileptic drugs. 		1st trimester 139 / 1875733 Authors excluded twin pregnancies and pregnancies with a chromosomal abnormality identified. Less than 90% of exposed pregnancies have a proxy for epilepsy. Publication's OR were not kept when lower limit of the confidence interval or OR equal to 0.
The French national health insurance database contains all health care claims reimbursed by French National Health Insurance. Include dispensed drugs coded according to the ATC classification. Monotherapy was defined as the absence of any other antiepileptic drug dispensed during the same period.
Christensen (Oxcarbazepine) (All indications) (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 who had redeemed at least one prescription of Oxcarbazepine 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) 1591 / 8756 Overlapping: For LBW and SGA: Christensen 2024 totally included Kilic 2014 and Artama 2013 => use of Christensen 2024 for these outcomes (longer study period, 5 countries and more pregnancies).
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 (Oxcarbazepine) (All indications) (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 who had redeemed at least one prescription of Oxcarbazepine 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 who had not redeemed prescription of anti-seizure medication. 		during pregnancy (anytime or not specified) 1591 / 4467848 Overlapping: For LBW and SGA: Christensen 2024 totally included Kilic 2014 and Artama 2013 => use of Christensen 2024 for these outcomes (longer study period, 5 countries and more pregnancies).
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 (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Indications NOS)
2013 		Denmark
1996 - 2006
population based cohort propective 		The Danish Civil Registration System, the Medical Birth Register and the Danish Register of Medicinal Product Statistics. Children whose mothers have been exposed to oxcarbazepine in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day of birth. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Children whose mothers have been exposed to lamotrigine in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day of birth. 		during pregnancy (anytime or not specified) 321 / 647 Indications not specified. Overlapping: For ASD diagnosis/risk : data of Christensen 2013 included in Bjork 2022 because longer study period and 5 countries => use of Bjork 2022 data.
The Danish Prescription Register holds information on prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes.
Christensen (Oxcarbazepine) (Controls unexposed NOS) (Indications NOS)
2013 		Denmark
1996 - 2006
population based cohort propective 		The Danish Civil Registration System, the Medical Birth Register and the Danish Register of Medicinal Product Statistics. Children whose mothers have been exposed to oxcarbazepine in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day of 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 oxcarbazepine during the exposure window defined from 30 days before the estimated day of conception to the day of birth. 		during pregnancy (anytime or not specified) 321 / 655205 Overlapping: For ASD diagnosis/risk : data of Christensen 2013 included in Bjork 2022 because longer study period and 5 countries => use of Bjork 2022 data. Indications not specified.
The Danish Prescription Register holds information on prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes.
Cohen (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications)
2019 		USA
2000 - 2010
retrospective cohort (claims database) 		Medicaid Analytic eXtract (MAX) Pregnancies in women with at least one dispensed prescription for oxcarbazepine monotherapy (no other mood stabilizers or other anticonvulsants) in the first 20 weeks of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Pregnancies in women with at least one dispensed prescription for lamotrigine monotherapy (no other mood stabilizers or other anticonvulsants) in the first 20 weeks of pregnancy. 		early pregnancy 1109 / 2682 Authors excluded deliveries with a major congenital malformation (identified by ICD-9).
The Medicaid Analytic Extract data include prescriptions filled on an outpatient basis.
Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications)
2019 		USA
2000 - 2010
retrospective cohort (claims database) 		Medicaid Analytic eXtract (MAX) Pregnancies in women with at least one dispensed prescription for oxcarbazepine monotherapy (no other mood stabilizers or other anticonvulsants) in the first 20 weeks of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Pregnancies in patients with no dispensing of lithium or any anticonvulsant (including those not used as mood stabilizers) from 3 months before pregnancy until 20 weeks of gestation. 		early pregnancy 1109 / 1440631 Authors excluded deliveries with a major congenital malformation (identified by ICD-9).
The Medicaid Analytic Extract data include prescriptions filled on an outpatient basis.
Cohen (Oxcarbazepine) (Epilepsy) (Controls exposed to LTG)
2023 		Denmark, Finland, Iceland, Norway, and Sweden
1996 - 2020
population based cohort retrospective 		Health national registers from the 5 Nordic countries. Pregnancies in which the mother had filled one or more prescriptions of oxcarbazepine ([ATC] code N03AF02) monotherapy during the first trimester. exposed to other treatment, sick
Pregnancies in which the mother had filled one or more prescriptions of lamotrigine monotherapy during the first trimester. 		1st trimester 1313 / 8339 Main oxcarbazepine indications: 96% epilepsy. Overlapping: Cohen 2023 included totally Christensen 2021 (excluded); and for Kallen 2013 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept.
Data on filled prescriptions were obtained from the medical birth registers linked with registers for prescribed drugs.
Cohen (Oxcarbazepine) (Epilepsy) (Controls unexposed, NOS)
2023 		Denmark, Finland, Iceland, Norway, and Sweden
1996 - 2020
population based cohort retrospective 		Health national registers from the 5 Nordic countries. Pregnancies in which the mother had filled one or more prescriptions of oxcarbazepine ([ATC] code N03AF02) monotherapy during the first trimester. unexposed (general population or NOS)
Pregnancies in which the mother had not filled a prescription for any Antiseizure medication (ATC code N03A) from 90 days before LMP to the end of the first trimester. 		1st trimester 1313 / 4866362 Overlapping: Cohen 2023 included totally Christensen 2021 (excluded); and for Kallen 2013 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. Main oxcarbazepine indication: 96% epilepsy.
Data on filled prescriptions were obtained from the medical birth registers linked with registers for prescribed drugs.
Coste (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2020 		France
2011 - 2014
retrospective cohort (claims database) 		The French national health data system (SNDS) Children born from mothers exposed to oxcarbazepine monotherapy indicated for the treatment of epilepsy with at least one dispensing between the month preceding onset of pregnancy and its end. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Children born from mothers exposed to lamotrigine monotherapy for mixed indications during pregnancy. 		during pregnancy (anytime or not specified) 143 / 2916 Children with a diagnosis of brain malformation (ICD-10 codes Q00 to Q04 and Q05.0 to Q05.4) during their stay in the maternity unit are excluded. Results are extracted from Blotière et al. 2020 because they reported aOR for vs LTG.
Defned by at least one dispensing of the drug to the mother between the beginning of the month preceding onset of pregnancy and the end of pregnancy. Mother had used this drug as monotherapy, defined by the use of a single drug during pregnancy.
Coste (Oxcarbazepine) (Controls unexposed, NOS)
2020 		France
2011 - 2014
retrospective cohort (claims database) 		The French national health data system (SNDS) Children born from mothers exposed to oxcarbazepine monotherapy indicated for the treatment of epilepsy with at least one dispensing between the month preceding onset of pregnancy and its end. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Children born from mothers not exposed to any antiepileptic drug during pregnancy. 		during pregnancy (anytime or not specified) 143 / 1710441 Children with a diagnosis of brain malformation (ICD-10 codes Q00 to Q04 and Q05.0 to Q05.4) during their stay in the maternity unit are excluded.
Defned by at least one dispensing of the drug to the mother between the beginning of the month preceding onset of pregnancy and the end of pregnancy. Mother had used this drug as monotherapy, defined by the use of a single drug during pregnancy.
Dreier (Oxcarbazepine) (Epilepsy) (Controls exposed to LTG)
2023 		Denmark, Finland, Iceland, Norway, and Sweden.
1996 - 2017
population based cohort propective 		A prospective, population-based register study within the SCAN-AED project, based on children born in Denmark, Finland, Iceland, Norway, and Sweden. Children prenatally exposed to Oxcarbazepine monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth. exposed to other treatment, sick
Children prenatally exposed to Lamotrigine monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth. 		during pregnancy (anytime or not specified) 1460 / 5288 Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Bjork 2022 => use of Bjork 2022 data. For ADHD: Christensen 2019 totally included in Dreier 2023.
Information on use of antiseizure medications was based on the national prescription registers, which contain information on all reimbursed prescription medications dispensed at pharmacies in each country, including date of dispensing and Anatomical Therapeutic Chemical (ATC) classification code.
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick)
2023 		Denmark, Finland, Iceland, Norway, and Sweden.
1996 - 2017
population based cohort propective 		A prospective, population-based register study within the SCAN-AED project, based on children born in Denmark, Finland, Iceland, Norway, and Sweden. Children prenatally exposed to Oxcarbazepine monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth. unexposed, sick
Children not prenatally exposed to antiseizure medication. 		during pregnancy (anytime or not specified) 1460 / 22203 Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Bjork 2022 => use of Bjork 2022 data. For ADHD: Christensen 2019 totally included in Dreier 2023.
Information on use of antiseizure medications was based on the national prescription registers, which contain information on all reimbursed prescription medications dispensed at pharmacies in each country, including date of dispensing and Anatomical Therapeutic Chemical (ATC) classification code.
Elkjaer (Oxcarbazepine)
2018 		Denmark
1997 - 2006
population based cohort propective 		The Danish Civil Registration System, the Danish Medical Birth Registry, the Danish Agency for Information Technology and Learning, the Danish Register of Medicinal Product Statistics. Children with oxcarbazepine monotherapy prescribed and redeemed within the exposure window defined from 30 days before the first day of the last menstrual period to 1 day before birth. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Children unexposed to any antiepileptic drugs in pregnancy. 		during pregnancy (anytime or not specified) 236 / 477162 There is no information about the exposure indication.
Information on medical exposure was retrieved from the Danish Register of Medicinal Product Statistics. Authors identified antiepileptic drugs with ATC codes N03A (AEDs) and N05BA09 (clobazam).
Guveli (Oxcarbazepine) (Epilepsy)
2017 		Turkey
1990 - 2006
retrospective cohort 		Departments of Istanbul Faculty of Medicine, Istanbul University, Turkey. Children born from mothers with epilepsy on Oxcarbazepine monotherapy during pregnancy. unexposed, sick
Children born from mothers were not exposed to Antiepileptic drugs (AED) during pregnancy. 		during pregnancy (anytime or not specified) 8 / 26
The clinical data of patients (dosages of AEDs used during pregnancy) were recorded retrospectively from patient files.
Hao (Oxcarbazepine) (Epilepsy) (Controls exposed to LTG)
2025 		China
Not specified.
prospective cohort 		The West China Registry of Pregnancy in Epilepsy (WCRP_ Epi), an ongoing prospective multicenter cohort study based in Sichuan Province, Southwest China. Pregnant women with confirmed epilepsy that used oxcarbazepine monotherapy during the first trimester of pregnancy. exposed to other treatment, sick
Pregnant women with confirmed epilepsy that used lamotrigine monotherapy during the first trimester of pregnancy. 		1st trimester 90 / 84 Use of monotherapy data (table 2).
Treatment information was collected through case report forms mainly through face-to-face visits in the neurology clinic or remotely by video/telephone calls, at each trimester of pregnancy.
Hao (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick)
2025 		China
Not specified.
prospective cohort 		The West China Registry of Pregnancy in Epilepsy (WCRP_ Epi), an ongoing prospective multicenter cohort study based in Sichuan Province, Southwest China. Pregnant women with confirmed epilepsy that used oxcarbazepine monotherapy during the first trimester of pregnancy. unexposed, sick
Pregnant women with confirmed epilepsy and no anti-seizure medication use during the first trimester. 		1st trimester 90 / 261 Use of monotherapy data (table 2).
Treatment information was collected through case report forms mainly through face-to-face visits in the neurology clinic or remotely by video/telephone calls, at each trimester of pregnancy.
Hosny (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2021 		Egypt
2018 - 2020
prospective cohort 		Kasr Al-Ainy Hospital, Cairo University, Egypt Pregnant women with epilepsy on oxcarbazepine monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Pregnant women with epilepsy on lamotrigine monotherapy during the first trimester. 		1st trimester 3 / 1 Each woman had one pregnancy during the study period. The correct figures were sent by the authors.
The following data were evaluated: seizure control 6 months before pregnancy, seizure control during each trimester, type and dose of ASMs at conception.
Hosny (Oxcarbazepine) (Controls unexposed, sick)
2021 		Egypt
2018 - 2020
prospective cohort 		Kasr Al-Ainy Hospital, Cairo University, Egypt Pregnant women with epilepsy on oxcarbazepine monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Pregnant women with epilepsy with no treatment during the first trimester. 		1st trimester 3 / 21 Each woman had one pregnancy during the study period. The correct figures were sent by the authors.
The following data were evaluated: seizure control 6 months before pregnancy, seizure control during each trimester, type and dose of ASMs at conception.
Hvas (Oxcarbazepine) (Controls unexposed, disease free)
2000 		Denmark
1989 - 1997
retrospective cohort 		Department of Obstetrics and Gynaecology at Aarhus University Hospital. Children of women with epilepsy exposed to oxcarbazepine 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 7 / 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 (Oxcarbazepine) (Controls unexposed, sick)
2000 		Denmark
1989 - 1997
retrospective cohort 		Department of Obstetrics and Gynaecology at Aarhus University Hospital. Children of women with epilepsy exposed to oxcarbazepine 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 7 / 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.
Kaaja (Oxcarbazepine)
2003 		Finland
1980 - 1998
prospective cohort 		Department of Obstetrics and Gynecology from Helsinki University Central Hospital Infants whose epileptic mothers took oxcarbazepine as monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Infants whose epileptic mothers didn't take any antiepileptic drugs during the first trimester. 		1st trimester 9 / 239
Follow-up of the pregnant women with epilepsy included assessment of serum concentration of antiepileptic drugs at the end of the first trimester.
Källén (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Indications NOS)
2013 		Swedish
1996 - 2011
population based cohort retrospective 		The Swedish Medical Birth Register, the Swedish Register of Prescribed Drugs the Register of Birth Defect and Hospital Discharge Register. Infants whose mothers used oxcarbazepine in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Infants whose mothers used lamotrigine in monotherapy in early pregnancy. 		early pregnancy 40 / 1084 Overlapping: Cohen 2023 and Kallen 2013 => less of 50% of overlapping => the 2 studies were kept. Razaz 2017 and Wide 2004 outcomes' already included in Källèn 2013 or not compared to an adequate control group. Follow-up period: author's email reply.
At the midwife interview at the first antenatal care visit, the woman was asked if she had used any drugs since she became pregnant. Or determined by the use of the Swedish Register of Prescribed Drugs (since 2006).
Källén (Oxcarbazepine) (Controls unexposed, NOS) (Indications NOS)
2013 		Swedish
1996 - 2011
population based cohort retrospective 		The Swedish Medical Birth Register, the Swedish Register of Prescribed Drugs, the Register of Birth Defect and Hospital Discharge Register. Infants whose mothers used oxcarbazepine in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Infants in population whose mothers used at least one of a central nervous system active drugs (less than 3%) or weren't exposed in early pregnancy. 		early pregnancy 40 / 1575847 Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply. Overlapping: Cohen 2023 and Kallen 2013 => less of 50% of overlapping => the 2 studies were kept. Follow-up period: author's email reply.
At the midwife interview at the first antenatal care visit, the woman was asked if she had used any drugs since she became pregnant. Or determined by the use of the Swedish Register of Prescribed Drugs (since 2006).
Kilic (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications)
2014 		Denmark
1997 - 2008
population based cohort retrospective 		The Danish Medical Birth Registry, the Danish Civil Registration System, the Danish National Hospital Registry, and the Danish Register of Medicinal Product Statistics. Children whose mothers have been exposed to oxcarbazepine in 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). exposed to other treatment, sick
Children whose mothers have been exposed to lamotrigine in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. 		during pregnancy (anytime or not specified) 310 / 880 Less than 90% of women are epileptic. Overlapping: For LBW and SGA: Kilic 2014 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes.
The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes.
Kilic (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications)
2014 		Denmark
1997 - 2008
population based cohort retrospective 		The Danish Medical Birth Registry, the Danish Civil Registration System, the Danish National Hospital Registry, and the Danish Register of Medicinal Product Statistics. Children whose mothers have been exposed to oxcarbazepine in 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. 		during pregnancy (anytime or not specified) 310 / 676834 Less than 90% of women are epileptic. Overlapping: For LBW and SGA: Kilic 2014 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes.
The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes.
Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications)
2014 		Denmark
1997 - 2008
population based cohort retrospective 		The Danish Medical Birth Registry, the Danish Civil Registration System, the Danish National Hospital Registry, and the Danish Register of Medicinal Product Statistics. Children whose mothers have been exposed to oxcarbazepine in 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, sick
Children whose mothers have an epilepsy diagnosis and haven't been exposed to antiepileptic drugs 30 days before the estimated day of conception to the day of birth. 		during pregnancy (anytime or not specified) 310 / 5296 Less than 90% of women are epileptic. Overlapping: For LBW and SGA: Kilic 2014 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes.
The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes.
Kini (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2007 		UK
2000 - 2004
prospective cohort 		4 centres within the Manchester area and 7 centres in the Cheshire and Merseyside regions. Children of epileptic mothers taking oxcarbazepine 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 (Oxcarbazepine) (Controls unexposed, disease free)
2007 		UK
2000 - 2004
prospective cohort 		4 centres within the Manchester area and 7 centres in the Cheshire and Merseyside regions. Children of epileptic mothers taking oxcarbazepine 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 (Oxcarbazepine) (Controls unexposed, sick)
2007 		UK
2000 - 2004
prospective cohort 		4 centres within the Manchester area and 7 centres in the Cheshire and Merseyside regions. Children of epileptic mothers taking oxcarbazepine 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.
Li (Oxcarbazepine) (Controls exposed to LTG)
2023 		China
2009 - 2022
prospective cohort 		A prospective cohort study entitled 'Construction and Application of the Women with Epilepsy of Child-bearing Age Ontology (WWECA)', with West China Hospital of Sichuan University as the main center. Women with epilepsy (WWE) using Oxcarbazepine monotherapy during pregnancy. exposed to other treatment, sick
Women with epilepsy (WWE) using Lamotrigine monotherapy during pregnancy. 		during pregnancy (anytime or not specified) 44 / 38 Authors did not provide analysis after monotherapy exposure but raw data of major congenital malformation provided in the e-Supp allowed to extract data for monotherapy => only this outcome reported here. Overlapping: He 2017 totally included in Li 2023.
The use of antiseizure medications on the included patients was registered by doctors and trained researchers.
Li (Oxcarbazepine) (Controls unexposed, sick)
2023 		China
2009 - 2022
prospective cohort 		A prospective cohort study entitled 'Construction and Application of the Women with Epilepsy of Child-bearing Age Ontology (WWECA)', with West China Hospital of Sichuan University as the main center. Women with epilepsy (WWE) using Oxcarbazepine monotherapy during pregnancy. unexposed, sick
Women with epilepsy (WWE) not using antiseizure medications during pregnancy. 		during pregnancy (anytime or not specified) 44 / 253 Authors did not provide analysis after monotherapy exposure but raw data of major congenital malformation provided in the e-Supp allowed to extract data for monotherapy => only this outcome reported here. Overlapping: He 2017 totally included in Li 2023.
The use of antiseizure medications on the included patients was registered by doctors and trained researchers.
Meador (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2021 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). Children with epileptic mothers using oxcarbazepine monotherapy in the third trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Children with epileptic mothers using lamotrigine monotherapy in the third trimester. 		3rd trimester 13 / 93 Exclusion criteria included history of psychogenic nonepileptic spells, expected IQ of less than 70, other major medical illness, and switching of ASMs in pregnancy before enrollment.
Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.
Meador (Oxcarbazepine) (Controls unexposed, disease free)
2021 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). Children with epileptic mothers using oxcarbazepine monotherapy in the third trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Children of healthy women. 		3rd trimester 13 / 106 Exclusion criteria included history of psychogenic nonepileptic spells, expected IQ of less than 70, other major medical illness, and switching of ASMs in pregnancy before enrollment.
Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2006 		UK and Ireland
1996 - 2005
prospective cohort 		The UK Epilepsy and Pregnancy Register Infants of women with epilepsy exposed to oxcarbazepine in monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Infants of women with epilepsy exposed to lamotrigine in monotherapy during the first trimester. 		1st trimester 7 / 647 Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.
Morrow (Oxcarbazepine) (Controls unexposed, sick)
2006 		UK and Ireland
1996 - 2005
prospective cohort 		The UK Epilepsy and Pregnancy Register Infants of women with epilepsy exposed to oxcarbazepine in monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Infants of women with epilepsy and who didn't take any antiepileptic drugs during pregnancy. 		1st trimester 7 / 227 Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.
Razaz (Oxcarbazepine) (Epilepsy)
2024 		Denmark, Finland, Iceland, Norway and Sweden.
1996 - 2017
population based cohort retrospective 		The SCAN-AED project, using the Nordic register infrastructures. Mothers with epilepsy who filled a prescription for Oxcarbazepine monotherapy between the date of the last menstrual period (LMP) and the day of birth. unexposed, sick
Mothers with epilepsy who did not fill an antiseizure medication (ASM) prescription in the period between 90 days before the last menstrual period (LMP) and the day of birth. 		during pregnancy (anytime or not specified) 1439 / 19043
Prescription for antiseizure medication (ASM) was ascertained using nationwide prescription registers and identified ASMs based on Anatomical Therapeutic Chemical Classification.
Samrén (Oxcarbazepine)
1999 		Netherlands
1972 - 1994
retrospective cohort 		28 hospitals in four provinces of the Netherlands and National Perinatal Data Base LVR. Children born to mothers with epilepsy and using oxcarbazepine monotherapy at least during the first trimester of pregnancy unexposed, disease free
Children born to nonepileptic nonexposed women. 		at least 1st trimester 2 / 2000
Data were collected from medical records and include medication. The prescribed dose of thedrugs was also retrieved from obstetric files.
The NAAED (Oxcarbazepine) (Controls exposed to LTG) (Indications NOS)
2023 		North America and Canada
1997 - 2022
prospective cohort 		The North American Antiepileptic Drug Pregnancy Register Infants of pregnant women who used Oxcarbazepine as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Infants of pregnant women who used lamotrigine as monotherapy, during the first trimester. 		1st trimester 327 / 2461 Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry website. Overlapping/update with Hernández-Díaz et al. 2012 and previous website reports.
Women are interviewed at enrollment, at 7 months’ gestation and at 8 –12 weeks after the expected date of delivery. The computer-assisted interviews include questions on start and stop dates of each antiepileptic drugs taken, dose, frequency and changes in medication.
The NAAED (Oxcarbazepine) (Controls unexposed, disease free) (Indications NOS)
2023 		North America and Canada
1997 - 2022
prospective cohort 		The North American Antiepileptic Drug Pregnancy Register Infants of pregnant women who used Oxcarbazepine as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Infants of pregnant women, not taking an antiepileptic drug and without epilepsy, who were recruited from among the friends and family members of the enrolled women taking an antiepileptic drug. 		1st trimester 327 / 1311 Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry website. Overlapping/update with Hernández-Díaz et al. 2012 and previous website reports. Use of internal control.
Women are interviewed at enrollment, at 7 months’ gestation and at 8 –12 weeks after the expected date of delivery. The computer-assisted interviews include questions on start and stop dates of each antiepileptic drugs taken, dose, frequency and changes in medication.
Thomas (Oxcarbazepine) (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 oxcarbazepine 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 71 / 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 (Oxcarbazepine) (Controls unexposed, disease free)
2021 		India
1998 - 2015
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) Children of women with epilepsy using oxcarbazepine 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, disease free
Children of women without epilepsy in the first trimester of pregnancy and not using antiepileptic drugs from the antenatal clinic of government hospital. 		1st trimester 41 / 319 This external control group is only available in the 2017 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 (Oxcarbazepine) (Controls unexposed, sick)
2021 		India
1998 - 2019
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) Children of women with epilepsy using oxcarbazepine 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 71 / 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.
Thomas (Oxcarbazepine) (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 Oxcarbazepine 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) 42 / 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 (Oxcarbazepine) (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 Oxcarbazepine 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) 42 / 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.
Tomson (Oxcarbazepine)
2018 		42 countries
1999 - 2016
prospective cohort 		The EURAP epilepsy and pregnancy registry Offspring exposed in utero to oxcarbamazepine monotherapy during the first trimester and born from epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Offspring exposed in utero to lamotrigine monotherapy during the first trimester and born from epileptic mothers. 		at least 1st trimester 333 / 2514 Overlapping/Update: (Major) malfo as a whole: Battino 2024 (1999-2022) updates Tomson 2018 (1999-2016) and Tomson 2011 => These outcomes are not reported here => use of Battino 2024.
Information obtained during early pregnancy and follow-up by the treating physician who transferred it online to a EURAP national coordinator. He then, reviewed the reports for completeness and accuracy before transmission to the EURAP central database.
Tomson (Oxcarbazepine)
2015 		42 countries
1999 - 2013
prospective cohort 		The EURAP epilepsy and pregnancy registry Pregnancies in women with epilepsy treated with oxcarbazepine monotherapy at least during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Pregnancies in women with epilepsy treated with lamotrigine monotherapy at least during the first trimester. 		at least 1st trimester 262 / 1910 Pregnancies that occurred in women without epilepsy were excluded. EURAP registry: potential overlap.
The data concerning treatment at the time of conception are obtained by the physicians responsible for the women’s care and transferred online. (Intention-to-treat principle).
Trivedi (Oxcarbazepine) (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 oxcarbazepine 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 56 / 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 (Oxcarbazepine) (Controls unexposed, sick)
2018 		India
1998 - 2015
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) Pregnant women with epilepsy who used oxcarbazepine 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 56 / 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 a (Oxcarbazepine) (Controls exposed to LTG) (Epilepsy)
2024 		Australia
1999 - 2023
prospective cohort 		The Australian Pregnancy Register of Antiepileptic Drugs (APR). Women with epilepsy exposed to Oxcarbazepine monotherapy during pregnancy. exposed to other treatment, sick
Women with epilepsy exposed to lamotrigine monotherapy during pregnancy. 		during pregnancy (anytime or not specified) 20 / 442 Overlapping between Vajda 2024a (1999 - 2023) and Vajda 2018 (1999 - 2016) based on the same register and for the almost same outcome (with or without elective termination) => Use of Vajda 2024a because accounting for more relevant confounders.
Not specified. All contact between the pregnant women and the Melbourne-based register has been by telephone.
Vajda a (Oxcarbazepine) (Controls unexposed sick) (Epilepsy)
2024 		Australia
1999 - 2023
prospective cohort 		The Australian Pregnancy Register of Antiepileptic Drugs (APR). Women with epilepsy exposed to Oxcarbazepine monotherapy during pregnancy. unexposed, sick
Women with epilepsy unexposed to antiseizure medication during pregnancy. 		during pregnancy (anytime or not specified) 20 / 184 Overlapping between Vajda 2024a (1999 - 2023) and Vajda 2018 (1999 - 2016) based on the same register and for the almost same outcome (with or without elective termination) => Use of Vajda 2024a because accounting for more relevant confounders.
Not specified. All contact between the pregnant women and the Melbourne-based register has been by telephone.
Vajda b (Oxcarbazepine) (Epilepsy) (Controls exposed to Lamotrigine, sick)
2024 		Australia
1999 - 2022
prospective cohort 		The Raoul Wallenberg Australian Pregnancy Register of Antiepileptic Drugs (referred to as ‘Australian Pregnancy Register’ from this point forward). Women with epilepsy exposed to oxcarbazepine in monotherapy in early pregnancy. exposed to other treatment, sick
Women with epilepsy exposed to lamotrigine in monotherapy in early pregnancy. 		early pregnancy 23 / 473 Overlapping: Vajda 2024 totally included other APR data (Vajda 2019; Vajda 2007; 2010 (x2); 2012 (x2); 2013; 2014). Study design partly completed with Vajda 2013.
Details are obtained by four in-depth telephone interviews with the women (at time of enrolment; at approximately 28 weeks of pregnancy; after the 1st post-partum (pp) month, and at one year pp). The accuracy of the information provided by the pregnant women is checked with their treating doctors.
Vajda b (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick)
2024 		Australia
1999 - 2022
prospective cohort 		The Raoul Wallenberg Australian Pregnancy Register of Antiepileptic Drugs (referred to as ‘Australian Pregnancy Register’ from this point forward). Women with epilepsy exposed to oxcarbazepine in monotherapy in early pregnancy. unexposed, sick
Women with epilepsy not treated with antiepileptic drugs in early pregnancy. 		at least 1st trimester 23 / 201 Overlapping: Vajda 2024 totally included other APR data (Vajda 2019; Vajda 2007; 2010 (x2); 2012 (x2); 2013; 2014). Study design partly completed with Vajda 2013.
Details are obtained by four in-depth telephone interviews with the women (at time of enrolment; at approximately 28 weeks of pregnancy; after the 1st post-partum (pp) month, and at one year pp). The accuracy of the information provided by the pregnant women is checked with their treating doctors.
Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications)
2014 		Norway
1999 - 2011
population based cohort retrospective 		Medical Birth Registry of Norway Children exposed prenatally to oxcarbazepine as monotherapy indicated for their mothers' epilepsy or other indications. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Children exposed prenatally to lamotrigine as monotherapy indicated for their mothers' epilepsy or other indications. 		throughout pregnancy 57 / 833 Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. Less than 90% of women are treated with Oxcarbazepine and Lamotrigine for epilepsy (Mixed indications).
A standardised notification form is filled in from the first prenatal visit with the general practitioner until discharge and transferred to the database by practitioners attending the delivery. (According to ATC Classification System).
Veiby (Oxcarbazepine) (Controls unexposed, disease free) (Mixed indications)
2014 		Norway
1999 - 2011
population based cohort retrospective 		Medical Birth Registry of Norway Children exposed prenatally to oxcarbazepine as monotherapy indicated for their mothers' epilepsy or other indications. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
All unexposed children born to women without epilepsy. 		throughout pregnancy 57 / 771412 Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. Less than 90% of women are treated with Oxcarbazepine for epilepsy (Mixed indications).
A standardised notification form is filled in from the first prenatal visit with the general practitioner until discharge and transferred to the database by practitioners attending the delivery. (According to ATC Classification System).
Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications)
2014 		Norway
1999 - 2011
population based cohort retrospective 		Medical Birth Registry of Norway Children exposed prenatally to oxcarbazepine as monotherapy indicated for their mothers' epilepsy or other indications. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Children born to women with a history of epilepsy but no antiepileptic drug treatment during pregnancy. 		throughout pregnancy 57 / 3773 Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. Less than 90% of women are treated with Oxcarbazepine for epilepsy (Mixed indications).
A standardised notification form is filled in from the first prenatal visit with the general practitioner until discharge and transferred to the database by practitioners attending the delivery. (According to ATC Classification System).
Videman (Oxcarbazepine) (Controls exposed to Lamotrigine, sick)
2016 		Finland
2009 - 2013
prospective cohort 		The Helsinki University Hospital Newborns from epileptic women with fetal monotherapy oxcarbazepine exposure during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Newborns from epileptic women with fetal monotherapy lamotrigine exposure during pregnancy. 		during pregnancy (anytime or not specified) 10 / 8 Study design partly completed with a previous article of Videman 2016.
Exposure data (including daily doses and serum levels for oxcarbazepine, carbamazepine, valproic acid, lamotrigine, and levetiracetam) were obtained prospectively at outpatient visits taking place every trimester and postnatally.
Videman (Oxcarbazepine) (Controls unexposed, disease free)
2016 		Finland
2009 - 2013
prospective cohort 		The Helsinki University Hospital Newborns from epileptic women with fetal monotherapy oxcarbazepine exposure during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Newborns from women with no antiepileptic drug or other brain-acting medication. 		during pregnancy (anytime or not specified) 10 / 67 Study design partly completed with a previous article of Videman 2016.
Exposure data (including daily doses and serum levels for oxcarbazepine, carbamazepine, valproic acid, lamotrigine, and levetiracetam) were obtained prospectively at outpatient visits taking place every trimester and postnatally.
Viinikainen (Oxcarbazepine) (Controls unexposed, disease free) a
2006 		Finland
1989 - 2000
prospective cohort 		Community-based pregnancy registry at the Kuopio University Hospital. Pregnancies of mothers who had active epilepsy and were using oxcarbazepine in monotherapy before conception and through the whole pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Pregnancies of mothers without epilepsy and unexposed to antiepileptic drugs. 		throughout pregnancy 2 / 24778 Multiple pregnancies and pregnancies with evident neonatal chromosomal abnormalities were excluded.
Obstetric data derived from the pregnancy registry and supplemented with medical records. And plasma levels of the antiepileptic drugs were monitoring during pregnancy at each control visit.
Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a
2006 		Finland
1989 - 2000
prospective cohort 		Community-based pregnancy registry at the Kuopio University Hospital. Pregnancies of mothers who had active epilepsy and were using oxcarbazepine in monotherapy before conception and through the whole pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Pregnancies of mothers who reported having previous history of epilepsy but no need for antiepileptic drugs at the time of the pregnancy. 		throughout pregnancy 2 / 52 Multiple pregnancies and pregnancies with evident neonatal chromosomal abnormalities were excluded.
Obstetric data derived from the pregnancy registry and supplemented with medical records. And plasma levels of the antiepileptic drugs were monitoring during pregnancy at each control visit.

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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