| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| AlSheikh (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 |
Saudi Arabia 2018 - 2019 |
Pregnant patients with active epilepsy admitted to the Obstetrics and Gynecology outpatient clinic and those seeking follow-up from our outpatient clinic. Patients on treatment and who had at least one seizure in the past one year. | 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. |
3 / 20 | |
| AlSheikh (Oxcarbazepine) (Controls unexposed, sick), 2020 |
Saudi Arabia 2018 - 2019 |
Pregnant patients with active epilepsy admitted to the Obstetrics and Gynecology outpatient clinic and those seeking follow-up from our outpatient clinic. Patients on treatment and who had at least one seizure in the past one year. | 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. |
3 / 8 | |
| Artama (Oxcarbazepine), 2005 |
Finland 1991 - 2000 |
Children born during the study period (n= 2350) to women who became eligible for full reimbursement for antiepileptic drugs with epilepsy as indication diagnosed before the birth. | 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. |
99 / 939 | |
| Artama (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2013 |
Finland 1996 - 2008 |
All singleton births (n = 751,139) in Finland during the study period. | 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. |
532 / 173 | |
| Artama (Oxcarbazepine) (Controls unexposed, disease free), 2013 |
Finland 1996 - 2008 |
All singleton births (n = 751,139) in Finland during the study period. | 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. |
532 / 721948 | |
| Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 |
Finland 1996 - 2008 |
All singleton births (n = 751,139) in Finland during the study period. | 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. |
532 / 1800 | |
| Aydin (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 |
Turkey 2007 - 2017 |
Pregnant women with epilepsy who delivered and had follow ups at the division of perinatalogy between the study period. | 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. |
4 / 7 | There were no patients who had drug changes or discontinued during pregnancy. |
| Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 |
Turkey 2007 - 2017 |
Pregnant women with epilepsy who delivered and had follow ups at the division of perinatalogy between the study period. | 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. |
4 / 22 | There were no patients who had drug changes or discontinued during pregnancy. |
| Bjørk (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | 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. |
1539 / 5073 | Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022 (92.9% of epileptic women), with more pregnancies (in epileptic women) in Dreier 2023 => use of Dreier 2023 data. |
| Bjørk (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2018 |
Norway 1999 - 2008 |
Pregnancies registered in the MoBa cohort when information concerning use of folic acid supplements and/or plasma folate concentration during pregnancy was available. | 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. |
9 / 104 | |
| Bjørk (Oxcarbazepine) (Controls unexposed NOS), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | 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). |
unexposed (general population or NOS)
Pregnacies in mothers without antiseizure medication prescription from her last menstrual period until birth. |
1539 / 4463879 | Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022 (92.9% of epileptic women), with more pregnancies (in epileptic women) in Dreier 2023 => use of Dreier 2023 data. |
| Bjørk (Oxcarbazepine) (Controls unexposed, disease free), 2018 |
Norway 1999 - 2008 |
Pregnancies registered in the MoBa cohort when information concerning use of folic acid supplements and/or plasma folate concentration during pregnancy was available. | 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. |
9 / 104222 | |
| Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies 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
Pregnacies in epileptic mothers without antiseizure medication prescription from her last menstrual period until birth. |
1429 / 21634 | Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022 (92.9% of epileptic women), with more pregnancies (in epileptic women) in Dreier 2023 => use of Dreier 2023 data. |
| Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2018 |
Norway 1999 - 2008 |
Pregnancies registered in the MoBa cohort when information concerning use of folic acid supplements and/or plasma folate concentration during pregnancy was available. | 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. |
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. |
| Cohen (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2019 |
USA 2000 - 2010 |
Deliveries during the study period in mothers 12-55 years of age with continuous enrollment from 3 months before pregnancy until 1 month after delivery. They are linked to live born infants in the database. | Restricted to pregnancies in women with epilepsy 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
Restricted to pregnancies in women with epilepsy with at least one dispensed prescription for lamotrigine monotherapy (no other mood stabilizers or other anticonvulsants) in the first 20 weeks of pregnancy. |
-9 / -9 | Authors excluded deliveries with a major congenital malformation (identified by ICD-9). No crude data are available for the epilepsy subgroup with monotherapy exposure. |
| Cohen (Oxcarbazepine) (Controls unexposed NOS), 2019 |
USA 2000 - 2010 |
Deliveries during the study period in mothers 12-55 years of age with continuous enrollment from 3 months before pregnancy until 1 month after delivery. They are linked to live born infants in the database. | Restricted to pregnancies in women with epilepsy 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. |
-9 / 1440631 | Authors excluded deliveries with a major congenital malformation (identified by ICD-9). No crude data are available for the epilepsy subgroup with monotherapy exposure. |
| Cohen (Oxcarbazepine) (Epilepsy) (Controls exposed to LTG), 2023 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2020 |
All pregnancies in the general population, including singleton and multiple births, live births and stillbirths, with a gestational age of at least 22 weeks occurring during the study period (terminations of pregnancy for fetal anomaly (TOPFAs) recorded in Norway, Finland and Denmark but not in Sweden or Iceland). | 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. |
1313 / 8339 | Main oxcarbazepine indications: 96% epilepsy. Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. |
| Cohen (Oxcarbazepine) (Epilepsy) (Controls unexposed, NOS), 2023 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2020 |
All pregnancies in the general population, including singleton and multiple births, live births and stillbirths, with a gestational age of at least 22 weeks occurring during the study period (terminations of pregnancy for fetal anomaly (TOPFAs) recorded in Norway, Finland and Denmark but not in Sweden or Iceland). | 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. |
1313 / 4866362 | Main oxcarbazepine indication: 96% epilepsy. Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. |
| Coste (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 |
France 2011 - 2014 |
All liveborn singleton children born during the study period. The mother had to be covered by the national health insurance general scheme for salaried workers and to have had at least one health expenditure reimbursement over the 2 years preceding the onset of pregnancy. | 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. |
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. |
| Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 |
France 2011 - 2014 |
All liveborn singleton children born during the study period. The mother had to be covered by the national health insurance general scheme for salaried workers and to have had at least one health expenditure reimbursement over the 2 years preceding the onset of pregnancy. | 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. |
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. |
| Dreier (Oxcarbazepine), 2021 |
Danemark, Finland, Iceland, Norway, Sweden 1996 (depends)-2017 |
Live-born singleton children from women with epilepsy in five Nordic countries. | Offspring of women with prescription for oxcarbazepine monotherapy from 90 days before pregnancy to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offspring of women with epilepsy not using antiseizure medication in pregnancy. |
1459 / -9 | Unknown number in the exposed and unexposed group (abstract). |
| Dreier (Oxcarbazepine) (Epilepsy) (Controls exposed to LTG), 2023 |
Denmark, Finland, Iceland, Norway, and Sweden. 1996 - 2017 |
Live-born singleton children of mothers with epilepsy in Denmark (1997-2017), Finland (1996- 2016), Iceland (2004-2017), Norway (2005-2017), and Sweden (2006-2017). | 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. |
1460 / 5288 | Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022 (92.9% of epileptic women), with more pregnancies (in epileptic women) in Dreier 2023 => use of Dreier 2023 data. |
| Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023 |
Denmark, Finland, Iceland, Norway, and Sweden. 1996 - 2017 |
Live-born singleton children of mothers with epilepsy in Denmark (1997-2017), Finland (1996- 2016), Iceland (2004-2017), Norway (2005-2017), and Sweden (2006-2017). | 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. |
1460 / 22203 | Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Dreier 2023 => use of Dreier 2023 data. |
| Elkjaer (Oxcarbazepine), 2018 |
Denmark 1997 - 2006 |
All children born alive in Denmark between the study period. | 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. |
236 / 477162 | There is no information about the exposure indication. |
| Hernández-Díaz (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2012 |
North America and Canada 1997 - 2011 |
Pregnant women who are taking an antiepileptic drug for any reason and had a liveborn infant, a stillborn infant, or a pregnancy terminated because of a fetal abnormality and enrolled as 'pure' or 'traditional' enrollees. | Infants of pregnant women who used oxcarbazepine for epileptic indication as monotherapy, during the first 4 lunar months after the last menstrual period (equal 16 weeks of gestation). (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 for mixed indications as monotherapy, during the first 4 lunar months after the last menstrual period (equal 16 weeks of gestation). |
182 / 1562 | Less than 90% of women are taking Lamotrigine for epilepsy. |
| Hernández-Díaz (Oxcarbazepine) (Controls unexposed, disease free), 2012 |
North America and Canada 1997 - 2011 |
Pregnant women who are taking an antiepileptic drug for any reason and had a liveborn infant, a stillborn infant, or a pregnancy terminated because of a fetal abnormality and enrolled as 'pure' or 'traditional' enrollees. | Infants of pregnant women who used oxcarbazepine for epileptic indication as monotherapy, during the first 4 lunar months after the last menstrual period (equal 16 weeks of gestation). (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. |
182 / 442 | |
| Hosny (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2021 |
Egypt 2018 - 2020 |
Pregnant women with epilepsy enrolled within the first trimester recruited from the epilepsy outpatient clinic and several private epilepsy centers during the study period. | 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. |
3 / 1 | Each woman had one pregnancy during the study period. The correct figures were sent by the authors. |
| Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021 |
Egypt 2018 - 2020 |
Pregnant women with epilepsy enrolled within the first trimester recruited from the epilepsy outpatient clinic and several private epilepsy centers during the study period. | 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. |
3 / 21 | Each woman had one pregnancy during the study period. The correct figures were sent by the authors. |
| Hvas (Oxcarbazepine) (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 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. |
7 / 24094 | |
| Hvas (Oxcarbazepine) (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 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. |
7 / 106 | |
| Kaaja (Oxcarbazepine), 2003 |
Finland 1980 - 1998 |
All women with epilepsy regardless of whether they used antiepileptic drugs during the index pregnancy. | 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. |
9 / 239 | |
| Kini (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2007 |
UK 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 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. |
1 / 15 | Details on the exposition measure were obtained from the publication of Mawer 2010. |
| Kini (Oxcarbazepine) (Controls unexposed, disease free), 2007 |
UK 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 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. |
1 / 236 | Details on the exposition measure were obtained from the publication of Mawer 2010. |
| Kini (Oxcarbazepine) (Controls unexposed, sick), 2007 |
UK 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 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. |
1 / 34 | Details on the exposition measure were obtained from the publication of Mawer 2010. |
| Li (Oxcarbazepine) (Controls exposed to LTG), 2023 |
China 2009 - 2022 |
All pregnant participants occurring between 2009 and 2022 in the cohort of women with epilepsy (WWE) of childbearing age (20–45 years old) enrolled from 31 medical institutions. | Women with epilepsy (WWE) using Oxcarbazepine monotherapy during pregnancy. |
exposed to other treatment, sick
Women with epilepsy (WWE) using Lamotrigine monotherapy during pregnancy. |
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. |
| Li (Oxcarbazepine) (Controls unexposed, sick), 2023 |
China 2009 - 2022 |
All pregnant participants occurring between 2009 and 2022 in the cohort of women with epilepsy (WWE) of childbearing age (20–45 years old) enrolled from 31 medical institutions. | Women with epilepsy (WWE) using Oxcarbazepine monotherapy during pregnancy. |
unexposed, sick
Women with epilepsy (WWE) not using antiseizure medications during pregnancy. |
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. |
| Meador (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2021 |
US 2012 - 2016 |
Pregnant (gestational age of 20 weeks or less) women with epilepsy and healthy women were recruited from the 20 epilepsy practices and through referral from obstetricians and other physicians as well as self-referral. | 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. |
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. |
| Meador (Oxcarbazepine) (Controls unexposed, disease free), 2021 |
US 2012 - 2016 |
Pregnant (gestational age of 20 weeks or less) women with epilepsy and healthy women were recruited from the 20 epilepsy practices and through referral from obstetricians and other physicians as well as self-referral. | 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. |
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. |
| Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 |
UK and Ireland 1996 - 2005 |
Pregnant women with epilepsy, whether or not they were taking an AED, either in monotherapy or polytherapy, and who were referred to the register before the outcome of the pregnancy was known. | 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. |
7 / 647 | Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study. |
| Morrow (Oxcarbazepine) (Controls unexposed, sick), 2006 |
UK and Ireland 1996 - 2005 |
Pregnant women with epilepsy, whether or not they were taking an antiepileptic drug, either in monotherapy or polytherapy, and who were referred to the register before the outcome of the pregnancy was known. | 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. |
7 / 227 | Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study. |
| Razaz (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2017 |
Sweden 1997- 2011 |
All singleton births at 22 or more completed gestational weeks. | Infants of mothers with epilepsy who had reimbursement for oxcarbazepine monotherapy between 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
Infants of mothers with epilepsy who had reimbursement for lamotrigine monotherapy between 30 days before the estimated day of conception to the day of birth. |
23 / 503 | |
| Razaz (Oxcarbazepine) (Controls unexposed, disease free), 2017 |
Sweden 1997- 2011 |
All singleton births at 22 or more completed gestational weeks. | Infants of mothers with epilepsy who had reimbursement for oxcarbazepine monotherapy between 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, disease free
Infants of mothers without epilepsy. |
23 / 1424279 | |
| Razaz (Oxcarbazepine) (Controls unexposed, sick), 2017 |
Sweden 1997- 2011 |
All singleton births at 22 or more completed gestational weeks. | Infants of mothers with epilepsy who had reimbursement for oxcarbazepine monotherapy between 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, sick
Infants of mothers with epilepsy not receiving antiepileptic drug between 30 days before the estimated day of conception to the day of birth. |
23 / 1868 | |
| Samrén (Oxcarbazepine), 1999 |
Netherlands 1972 - 1994 |
Offspring of women with epilepsy, with or without antiepileptic drug use during pregnancy, born during the study period. | 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. |
2 / 2000 | |
| Thomas (Oxcarbazepine) (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 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. |
71 / 50 | Study design completed with Thomas et al., 2017. Keni's 2018 malformations results are already reported in this publication. |
| Thomas (Oxcarbazepine) (Controls unexposed, disease free), 2021 |
India 1998 - 2015 |
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 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. |
41 / 319 | This external control group is only available in the 2017 publication. |
| Thomas (Oxcarbazepine) (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 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. |
71 / 340 | Study design completed with Thomas et al., 2017. |
| Tomson (Oxcarbazepine), 2015 |
42 countries 1999 - 2013 |
Pregnant women (n=6,146) treated with antiepileptic drugs for any indication at the time of conception, enrolment within gestation week 16 and before fetal outcome is known. | 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. |
262 / 1910 | Pregnancies that occurred in women without epilepsy were excluded. EURAP registry: potential overlap. |
| Tomson (Oxcarbazepine) , 2018 |
42 countries 1999 - 2016 |
Pregnancies registered in the database during the study period who had been exposed to antiepileptic drug monotherapy and had complete follow-up data up to 1 year. They were enrolled within gestation week 16 and before fetal outcome is known. | Offspring exposed in utero to oxcarbazepine 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. |
333 / 2514 | This study is an update of Tomson's 2011 publication. They excluded from the current analysis pregnancies occurring in women without epilepsy. EURAP registry: potential overlap. |
| Trivedi (Oxcarbazepine) (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 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. |
56 / 48 | Study design partly completed with cites source Thomas et al., 2017. |
| Trivedi (Oxcarbazepine) (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 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. |
56 / 178 | Study design partly completed with cites source Thomas et al., 2017. |
| Vajda (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2018 |
Australia 1999 - 2016 |
Pregnant women whether treated with antiepileptic drugs or left untreated in at least the first half of pregnancy. | Offsprings of pregnant women with epilepsy exposed to oxcarbazepine in monotherapy throughout. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Offsprings of pregnant women with epilepsy exposed to lamotrigine in monotherapy throughout. |
19 / 382 | |
| Vajda (Oxcarbazepine) (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 oxcarbazepine 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. |
19 / 406 | Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2013, 2010 and 2014. Study design partly completed with Vajda 2013. |
| Vajda (Oxcarbazepine) (Controls unexposed, sick), 2018 |
Australia 1999 - 2016 |
Pregnant women whether treated with antiepileptic drugs or left untreated in at least the first half of pregnancy. | Offsprings of pregnant women with epilepsy exposed to oxcarbazepine in monotherapy throughout. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offsprings of pregnant women with epilepsy that have been untreated in at least the first half of pregnancy. |
19 / 170 | |
| Vajda (Oxcarbazepine) (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 oxcarbazepine 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. |
19 / 176 | Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2013, 2010 and 2014. Study design partly completed with Vajda 2013. |
| Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to oxcarbazepine as monotherapy indicated for their mothers' epilepsy. (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. |
51 / 593 | We will only consider the subgroup of women exposed to antiepileptic drugs for the strict indication of epilepsy. Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. |
| Veiby (Oxcarbazepine) (Controls unexposed, disease free), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to oxcarbazepine as monotherapy indicated for their mothers' epilepsy. (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. |
51 / 771412 | Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. We will only consider the subgroup of women exposed to antiepileptic drugs for the strict indication of epilepsy. |
| Veiby (Oxcarbazepine) (Controls unexposed, sick), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to oxcarbazepine as monotherapy indicated for their mothers' epilepsy. (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. |
51 / 3773 | Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. We will only consider the subgroup of women exposed to antiepileptic drugs for the strict indication of epilepsy. |
| Videman (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2016 |
Finland 2009 - 2013 |
All pregnant women with epilepsy (PWE) treated with antiepileptic drugs living in Helsinki between the study period. Pregnant women with no antiepileptic drug or other brain-acting medication was recruited by a nurse during regular pregnancy monitoring in an outpatient clinic or by a newspaper announcement. | 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. |
10 / 8 | Study design partly completed with a previous article of Videman 2016. |
| Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016 |
Finland 2009 - 2013 |
All pregnant women with epilepsy (PWE) treated with antiepileptic drugs living in Helsinki between the study period. Pregnant women with no antiepileptic drug or other brain-acting medication was recruited by a nurse during regular pregnancy monitoring in an outpatient clinic or by a newspaper announcement. | 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. |
10 / 67 | Study design partly completed with a previous article of Videman 2016. |
| Viinikainen (Oxcarbazepine) (Controls unexposed, disease free) a, 2006 |
Finland 1989 - 2000 |
24,778 singleton pregnancies in 16,598 women and 179 of these were pregnancies of women with epilepsy followed up during the pregnancy by the Department of Neurology and gave birth in the 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. |
2 / 24778 | Multiple pregnancies and pregnancies with evident neonatal chromosomal abnormalities were excluded. |
| Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 |
Finland 1989 - 2000 |
24,778 singleton pregnancies in 16,598 women and 179 of these were pregnancies of women with epilepsy followed up during the pregnancy by the Department of Neurology and gave birth in the 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. |
2 / 52 | Multiple pregnancies and pregnancies with evident neonatal chromosomal abnormalities were excluded. |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|
3 studies, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.
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