| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| Alsaadi (Controls exposed to LTG), 2020 |
United Arab Emirates 2008 - 2015 |
Women with epilepsy who attended the Obstetric Medicine Neurology Clinic at Corniche Hospital in Abu Dhabi, United Arab Emirates (UAE). | Women with epilepsy who were taking Levetiracetam in monotherapy during the first trimester of pregnancy. |
exposed to other treatment, sick
Women with epilepsy who were taking Lamotrigine in monotherapy during the first trimester of pregnancy. |
46 / 13 | |
| Alsaadi (Controls unexposed sick), 2020 |
United Arab Emirates 2008 - 2015 |
Women with epilepsy who attended the Obstetric Medicine Neurology Clinic at Corniche Hospital in Abu Dhabi, United Arab Emirates (UAE). | Women with epilepsy who were taking Levetiracetam in monotherapy during the first trimester of pregnancy. |
unexposed, sick
Women with epilepsy who were not taking antiseizure drugs (ASDs) during the first trimester of pregnancy. |
46 / 40 | |
| Alsfouk (Levetiracetam), 2022 |
Riyadh and Jeddah, Saudi Arabia. 2005 - 2020 |
Pregnant women with epilepsy followed up prospectively between the study period. | Epileptic mothers with levetiracetam monotherapy administered during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Epileptic mothers with lamotrigine monotherapy administered during pregnancy. |
24 / 15 | |
| Alsfouk (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2021 |
Riyadh and Jeddah, Saudi Arabia. 1993 - 2020 |
Pregnant women with epilepsy followed up prospectively between the study period. | Epileptic mothers with levetiracetam monotherapy administered during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Epileptic mothers with lamotrigine monotherapy administered during pregnancy. |
24 / 15 | |
| Alsfouk (Levetiracetam) (Controls unexposed, sick), 2021 |
Riyadh and Jeddah, Saudi Arabia. 1993 - 2020 |
Pregnant women with epilepsy followed up prospectively between the study period. | Epileptic mothers with levetiracetam monotherapy administered during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Epileptic mothers who did not take antiseizure medications during pregnancies. |
24 / 30 | |
| AlSheikh (Levetiracetam) (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 levetiracetam 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. |
9 / 20 | |
| AlSheikh (Levetiracetam) (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 levetiracetam 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. |
9 / 8 | |
| Arkilo (Levetiracetam), 2015 |
USA 2006 - 2011 |
Women with epilepsy who were pregnant between the study period and exposed to monotherapy antiepileptic medication at any point during the pregnancy. | Singleton whose epileptic mothers were exposed to levetiracetam monotherapy at any point during the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Singleton whose epileptic mothers were exposed to lamotrigine monotherapy at any point during the pregnancy. |
11 / 24 | |
| Artama (Levetiracetam) (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 levetiracetam 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. |
13 / 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. |
| Artama (Levetiracetam) (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 levetiracetam 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. |
13 / 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. |
| Artama (Levetiracetam) (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 levetiracetam 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. |
13 / 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. |
| Aydin (Levetiracetam) (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 levetiracetam 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. |
10 / 7 | There were no patients who had drug changes or discontinued during pregnancy. |
| Aydin (Levetiracetam) (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 levetiracetam 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. |
10 / 22 | There were no patients who had drug changes or discontinued during pregnancy. |
| Babic (Levetiracetam), 2014 |
Serbia 1998 - 2008 |
During the study period 21 women (25 pregnancies) with juvenile myoclonic epilepsy were enrolled. | Children whose epileptic mothers were exposed to levetiracetam in monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children whose epileptic mothers were exposed to lamotrigine in monotherapy during pregnancy. |
4 / 8 | |
| Battino, 2024 |
Worldwide (47 countries) 1999 - 2022 |
Pregnant women with epilepsy exposed to antiseizure medications at the time of conception and enrolled within the 16th week of gestation, where fetal outcome had not yet been determined. | Pregnant women with epilepsy exposed to Levetiracetam monotherapy at the time of conception. |
exposed to other treatment, sick
Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception. |
1325 / 3584 | Overlapping/Update: (Major) malfo as a whole: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016), Huber-Mollema 2019, Martinez 2018, Tomson 2011 => Use of Battino 2024 for these outcomes. |
| Bhaskaran, 2025 |
India Not specified. |
Children born to mothers with epilepsy consecutively chosen in the Kerala Registry of Epilepsy and Pregnancy (KREP) and without epilepsy chosen by convenience sampling from Child Development Centre. | Children born to mothers with epilepsy with levetiracetam monotherapy during pregnancy. |
unexposed, disease free
Children born to mothers with no epilepsy during pregnancy and not exposed to antiseizure medications, chosen by convenience sampling from Child Development Centre which is a government aided tertiary care centre in South Kerala. |
10 / 50 | Overlapping: LEV: data of Psychomotor and cognitive outcomes included in Thomas 2022a and b with more pregnancies and more relevant control groups => only langage outcomes of Bhaskaran 2025 reported here. |
| Bjørk (Levetiracetam) (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 levetiracetam 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. |
1017 / 5073 | Overlapping for ASD (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Dreier 2023 => use of Dreier 2023 data. Intellectual disability not implemented owing to personal data protection restrictions on publishing cell counts less than 5. |
| Bjørk (Levetiracetam) (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 levetiracetam 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. |
16 / 104 | |
| Bjørk (Levetiracetam) (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 levetiracetam 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. |
1017 / 4463879 | Overlapping for ASD (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Dreier 2023 => use of Dreier 2023 data. Intellectual disability not implemented owing to personal data protection restrictions on publishing cell counts less than 5. |
| Bjørk (Levetiracetam) (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 levetiracetam 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. |
16 / 104222 | |
| Bjørk (Levetiracetam) (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 levetiracetam 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. |
1004 / 21634 | Overlapping for ASD (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Dreier 2023 => use of Dreier 2023 data. Intellectual disability not implemented owing to personal data protection restrictions on publishing cell counts less than 5. |
| Bjørk (Levetiracetam) (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 levetiracetam 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. |
16 / 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. |
| Bromley (Levetiracetam), 2016 |
UK 2004 - 2007 |
Pregnant women with epilepsy, whether or not they were taking an antiepileptic drug in monotherapy and whose infant had been a live birth between the study period. | Children whose epileptic mothers were exposed to levetiracetam monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children whose epileptic mothers were untreated by antiepileptic drugs during their pregnancy. |
42 / 55 | Design parts of this study were completed thanks to Morrow 2006. Families were not invited to participate if their child had a genetic condition associated with neurodevelopmental impairment. |
| Bromley (Levetiracetam) (Controls exposed to LTG), 2023 |
United Kingdom 2014 - 2016 |
Pregnant women with epilepsy, of <21 weeks gestation, recruited from 21 hospitals in the UK (across the North West and North East of England and from Northern Ireland). | Pregnant women with epilepsy exposed to Levetiracetam during pregnancy. |
exposed to other treatment, sick
Pregnant women with epilepsy exposed to Lamotrigine during pregnancy. |
70 / 106 | |
| Bromley (Levetiracetam) (Controls unexposed, sick), 2023 |
United Kingdom 2014 - 2016 |
Pregnant women with epilepsy, of <21 weeks gestation, recruited from 21 hospitals in the UK (across the North West and North East of England and from Northern Ireland). | Pregnant women with epilepsy exposed to Levetiracetam during pregnancy. |
unexposed, sick
Pregnant women with epilepsy and with no antiseizure medication. |
70 / 80 | |
| Christensen (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2024 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 |
All live-born singletons born of women with epilepsy in the included countries during the study periods. | Children of mothers with epilepsy who had redeemed at least one prescription of Levetiracetam 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). |
1063 / 5299 | Overlapping: For LBW and SGA: Christensen 2024 totally included Artama 2013 => use of Christensen 2024 for these outcomes (longer study period, 5 countries and more pregnancies). |
| Christensen (Levetiracetam) (Epilepsy) (Controls unexposed, general population), 2024 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 |
All live-born singletons born of women with epilepsy in the included countries during the study periods. | Children of mothers with epilepsy who had redeemed at least one prescription of Levetiracetam monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period). |
unexposed, sick
Children of mothers with epilepsy who had not redeemed prescription of anti-seizure medication. |
1063 / 22227 | Overlapping: For LBW and SGA: Christensen 2024 totally included Artama 2013 => use of Christensen 2024 for these outcomes (longer study period, 5 countries and more pregnancies). |
| Cohen (Levetiracetam) (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 levetiracetam ([ATC] code N03AX14) 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. |
1040 / 8339 | Main levetiracetam indication: 99% epilepsy. Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. |
| Cohen (Levetiracetam) (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 levetiracetam ([ATC] code N03AX14) 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. |
1040 / 4866362 | Main levetiracetam indication: 99% epilepsy. Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. |
| Coste (Levetiracetam) (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 levetiracetam 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 (i.e. with no other medication indicated for epilepsy) indicated for the treatment of epilepsy during pregnancy. |
621 / 2108 | 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 (Levetiracetam) (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 levetiracetam 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. |
621 / 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 (Levetiracetam) (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 Levetiracetam 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. |
1061 / 5288 | Overlapping for ASD (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Dreier 2023 => use of Dreier 2023 data. |
| Dreier (Levetiracetam) (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 Levetiracetam 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. |
1061 / 22203 | Overlapping for ASD (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Dreier 2023 => use of Dreier 2023 data. |
| Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 |
Turkey Not specified. |
Pregnant women with a diagnosis of epilepsy who were continuously treated with Levetiracetam, Lamotrigine or Carbamazepine from conception throughout pregnancy. | Pregnant women with a diagnosis of epilepsy who were continuously treated with Levetiracetam monotherapy from conception throughout pregnancy. |
exposed to other treatment, sick
Pregnant women with a diagnosis of epilepsy who were continuously treated with Lamotrigine monotherapy from conception throughout pregnancy. |
18 / 9 | |
| Hao (Controls exposed to LTG), 2025 |
China Not specified. |
Women with confirmed epilepsy of childbearing age attending the neurology or gynecology clinics in one of four large hospital. | Pregnant women with confirmed epilepsy that used levetiracetam 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. |
268 / 84 | Use of monotherapy data (table 2). |
| Hao (Controls unexposed, sick), 2025 |
China Not specified. |
Women with confirmed epilepsy of childbearing age attending the neurology or gynecology clinics in one of four large hospital. | Pregnant women with confirmed epilepsy that used levetiracetam monotherapy during the first trimester of pregnancy. |
unexposed, sick
Pregnant women with confirmed epilepsy and no anti-seizure medication use during the first trimester. |
268 / 261 | Use of monotherapy data (table 2). |
| Hernández-Díaz (Levetiracetam) (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 levetiracetam 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). |
450 / 1562 | Less than 90% of women are taking Lamotrigine for epilepsy. |
| Hernández-Díaz (Levetiracetam) (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 levetiracetam 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. |
450 / 442 | |
| Hoeltzenbein (Levetiracetam), 2024 |
Germany 2000 - 2017 |
Pregnancies identified through risk consultation at the Embryotox Center enrolled during the study period. | Pregnancies with levetiracetam monotherapy for epilepsy during the first trimester. |
exposed to other treatment, sick
Pregnancies with monotherapy of lamotrigine in women with epilepsy. |
221 / 469 | The median daily levetiracetam dose at conception was 1500mg (interquartile range [IQR] =1000–2000mg, n=339). Data of overall levetiracetam cohort not reported because mono and polytherapies (60/40%). |
| Hosny (Levetiracetam) (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 levetiracetam 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. |
67 / 1 | Each woman had one pregnancy during the study period. The correct figures were sent by the authors. |
| Hosny (Levetiracetam) (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 levetiracetam 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. |
67 / 21 | Each woman had one pregnancy during the study period. The correct figures were sent by the authors. |
| Huber-Mollema (Levetiracetam), 2019 |
The Netherlands 2015 - 2018 |
Children of mothers with epilepsy identified from the EURAP‐NL database. Recruitment of women ideally occurs within the first 16 weeks of pregnancy. | Children age between 6 years and 7 years 11 months of mothers with epilepsy exposed to levetiracetam monotherapy starting before conception and continuing during the entire pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children age between 6 years and 7 years 11 months of mothers with epilepsy exposed to lamotrigine monotherapy starting before conception and continuing during the entire pregnancy. |
30 / 88 | The method for measuring exposure is not specified, although the EURAP registry method was thought to be used. Overlapping: For malformations: data totally included in Battino 2024 => not reported here. |
| Husebye (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020 |
Norway 1999 - 2008 |
Children of mothers with and without epilepsy included in the MoBa cohort. | Children of mothers with epilepsy exposed to levetiracetam monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children of mothers with epilepsy exposed to lamotrigine monotherapy during pregnancy. |
17 / 112 | |
| Husebye (Levetiracetam) (Controls unexposed, disease free), 2020 |
Norway 1999 - 2008 |
Children of mothers with and without epilepsy included in the MoBa cohort. | Children of mothers with epilepsy exposed to levetiracetam monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Children of mothers without epilepsy. |
17 / 113674 | |
| Husebye (Levetiracetam) (Controls unexposed, sick), 2020 |
Norway 1999 - 2008 |
Children of mothers with and without epilepsy included in the MoBa cohort. | Children of mothers with epilepsy exposed to levetiracetam monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children of mothers with epilepsy unexposed to antiepileptic durgs during pregnancy. |
17 / 388 | For this comparison group, results are only available according to folic acid intake. |
| Koc (Levetiracetam), 2018 |
Turkey 2001 - 2017 |
The files of pregnant women with epilepsy who were followed-up during the study period. | Pregnancies in women with epilepsy who were exposed to levetiracetam treatment during pregnancy in the form of monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnancies in women with epilepsy who did not receive any antiepileptic drug during pregnancy. |
30 / 35 | |
| Li (Levetiracetam) (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 Levetiracetam monotherapy during pregnancy. |
exposed to other treatment, sick
Women with epilepsy (WWE) using Lamotrigine monotherapy during pregnancy. |
107 / 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 (Levetiracetam) (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 Levetiracetam monotherapy during pregnancy. |
unexposed, sick
Women with epilepsy (WWE) not using antiseizure medications during pregnancy. |
107 / 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. |
| Madley-Dowd_SE (Levetiracetam) (Controls exposed to LTG), 2024 |
Sweden 1995 - 2020 |
All liveborn children born between July 1, 1995, and December 31, 2020. | Fetal exposure to Levetiracetam monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy. |
exposed to other treatment, sick
Fetal exposure to Lamotrigine monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy. |
556 / 2383 | Data extracted from the e-Supp pdf (Table S10). |
| Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sick), 2024 |
Sweden 1995 - 2020 |
All liveborn children born between July 1, 1995, and December 31, 2020. | Fetal exposure to Levetiracetam monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy. |
unexposed, sick
No fetal exposure to antiseizure medication at any time during the pregnancy period, restricted for epilepsy indication. |
556 / 10769 | Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10). |
| Madley-Dowd_UK (Levetiracetam) (Epilepsy), 2024 |
United Kingdom 1995 - 2018 |
All liveborn children of women aged 11–49 years in the Clinical Practice Research Datalink (CPRD) Pregnancy Register born between January 1, 1995, and December 31, 2018. | Fetal exposure to Levetiracetam monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period. |
unexposed, sick
No fetal exposure to antiseizure medication at any time during the pregnancy period, restricted for epilepsy indication. |
174 / 4075 | Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10). |
| Margulis, 2019 |
Sweden 1996 - 2013 |
All women with records for AEDs in pregnancy who delivered a live infant with gestational age of 24 to 42 completed weeks in 1996–2013 and their newborns. | Infants whose mothers reported use of levetiracetam monotherapy at any time during pregnancy. |
exposed to other treatment, sick
Infants whose mothers reported use of lamotrigine at any time during pregnancy. |
127 / 1812 | Monotherapy results available in e-Supp tables (S3 File). |
| Mari (Levetiracetam), 2022 |
Rome, Italy 2009 - 2019 |
Pregnant women with focal epilepsy (FE) or generalized epilepsy (GE) followed at epilepsy centers during the study period including women on Anti-seizure medications with carbamazepine, lamotrigine or levetiracetam. | Women with focal epilepsy (FE) or generalized epilepsy (GE) undergoing Anti-seizure medications monotherapy with levetiracetam. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Women with focal epilepsy (FE) or generalized epilepsy (GE) undergoing Anti-seizure medications monotherapy with lamotrigine. |
17 / 11 | In 46 out of 57 pregnancies, ASMs therapy remained unchanged during gestation (only one switch from CBZ to LEV, others are dosage-related). |
| Meador (Controls exposed to LTG), 2023 |
USA 2012 - 2016 |
Children of pregnant women (aged 14–45 years) with and without epilepsy who were enrolled during pregnancy (≤20 weeks’ gestational age). | Children born to women with epilepsy treated with Levetiracetam monotherapy. |
exposed to other treatment, sick
Children born to women with epilepsy treated with lamotrigine monotherapy. |
74 / 90 | Overlapping: Meador 2021 and 2023 used the same cohort in order to study the same outcome, at 2 different ages (=> use of the data on the older children, i.e Meador 2023). |
| Meador (Controls unexposed, disease free), 2023 |
USA 2012 - 2016 |
Children of pregnant women (aged 14–45 years) with and without epilepsy who were enrolled during pregnancy (≤20 weeks’ gestational age). | Children born to women with epilepsy treated with Levetiracetam monotherapy. |
unexposed, disease free
Children born to women without epilepsy. |
74 / 106 | Overlapping: Meador 2021 and 2023 used the same cohort in order to study the same outcome, at 2 different ages (=> use of the data on the older children, i.e Meador 2023). |
| Meador (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020 |
US 2012 - 2016 |
Pregenant women with epilepsy were recruited primarily from the clinical populations at the 20 MONEAD sites, but also via referral from physicians, as well as self-referral. They were ages 14–45 years and ≤20 weeks gestational age. | Children born to pregnant women with epilepsy exposed to levetiracetam 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
Children born to pregnant women with epilepsy exposed to lamotrigine monotherapy during the first trimester. |
99 / 113 | |
| Meador (Levetiracetam) (Controls unexposed, disease free), 2020 |
US 2012 - 2016 |
Pregenant women with epilepsy were recruited primarily from the clinical populations at the 20 MONEAD sites, but also via referral from physicians, as well as self-referral. They were ages 14–45 years and ≤20 weeks gestational age. | Children born to pregnant women with epilepsy exposed to levetiracetam monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Children born to healthy pregnant women. |
99 / 106 | |
| Meador (Levetiracetam) (Controls unexposed, sick), 2020 |
US 2012 - 2016 |
Pregenant women with epilepsy were recruited primarily from the clinical populations at the 20 MONEAD sites, but also via referral from physicians, as well as self-referral. They were ages 14–45 years and ≤20 weeks gestational age. | Children born to pregnant women with epilepsy exposed to levetiracetam monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children born to pregnant women with epilepsy with no antiepileptic drug use. |
99 / 15 | |
| Morrow (Levetiracetam) (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 levetiracetam 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. |
22 / 647 | Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study. |
| Morrow (Levetiracetam) (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 levetiracetam 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. |
22 / 227 | Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study. |
| Pekoz (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023 |
Turkey 2014 - 2019 |
Pregnant women with epilepsy (PWWE) followed up at the participating centers during the study period, with a live birth. | Pregnant women with epilepsy (PWWE) receiving Levetiracetam as monotherapy. |
exposed to other treatment, sick
Pregnant women with epilepsy (PWWE) receiving Lamotrigine as monotherapy. |
152 / 141 | |
| Pekoz (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 |
Turkey 2014 - 2019 |
Pregnant women with epilepsy (PWWE) followed up at the participating centers during the study period, with a live birth. | Pregnant women with epilepsy (PWWE) receiving Levetiracetam as monotherapy. |
unexposed, sick
Pregnant women with epilepsy (PWWE), antiseizure medication free. |
152 / 43 | |
| Razaz (Levetiracetam), 2024 |
Denmark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
All singleton births at 22 or more completed gestational weeks in the 5 Nordic countries during the different study periods. | Mothers with epilepsy who filled a prescription for Levetiracetam 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. |
1009 / 19043 | |
| Shallcross (Levetiracetam), 2011 |
UK and Ireland 2003 - 2010 |
Women taking levetiracetam or valproate monotherapy during their pregnancy and with an IQ above 70 and whose children were below the age of 2 years at the time of assessment were recruited. | Children born to women with epilepsy exposed to levetiracetam monotherapy throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Children born to women without epilepsy, not taking medication during pregnancy. |
51 / 97 | Control children were recruited from the LMNDG program. Study design is partly completed with cited source [13]. |
| Stjerna (Levetiracetam) (Epilepsy), 2024 |
Czech Republic, Finland, Germany, Italy, Spain, Sweden and the Netherlands. 2008 - 2020 |
Mother–child pairs identified from the core EURAP study and corresponding to criteria for eligibility (exposure, mother’s ability to take care of the child, vailability of information on potential confounders and no significant pre-, peri- and postnatal neurological co-morbidity of the child). | Children of mothers with epilepsy that used Levetiracetam monotherapy during the entire period from conception to birth. |
exposed to other treatment, sick
Children of mothers with epilepsy that used lamotrigine monotherapy during the entire period from conception to birth. |
18 / 82 | Use of adjusted continuous data (transformed in OR) rather than unadjusted dichotomised data. Indications: Epilepsy (Table 1). Overlapping: Huber-Mollema 2020 (n=99; NL only) totally included in Stjerna 2024 (n=162; 7 countries) => Use of Stjerna. |
| Thomas (Controls exposed to LTG), 2022 |
India 1998 - 2019 |
All babies of women with epilepsy (WWE) enrolled in the pre-pregnancy stage or in the first trimester of pregnancy, who were over 12 months of age on 31st December, 2020 (and less than 24 months). | Infants of women with epilepsy who were exposed to Levetiracetam 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. |
62 / 26 | No use of delayed mental development, because discrepancy in LTG data '1/26 (11.5%)'. |
| Thomas (Controls unexposed, sick), 2022 |
India 1998 - 2019 |
All babies of women with epilepsy (WWE) enrolled in the pre-pregnancy stage or in the first trimester of pregnancy, who were over 12 months of age on 31st December, 2020 (and less than 24 months). | Infants of women with epilepsy who were exposed to Levetiracetam 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. |
62 / 110 | Trend of lower aMODQ and aMEDQ with medium and high doses, compared to low dose of the same drug. |
| Thomas (Levetiracetam) (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 levetiracetam 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. |
106 / 50 | Study design completed with Thomas et al., 2017. Keni's 2018 malformations results are already reported in this publication. |
| Thomas (Levetiracetam) (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 levetiracetam 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. |
30 / 319 | This external control group is only available in the 2017 publication. |
| Thomas (Levetiracetam) (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 levetiracetam 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. |
106 / 340 | Study design completed with Thomas et al., 2017. |
| Tomson (Levetiracetam), 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 levetiracetam 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. |
324 / 1910 | Pregnancies that occurred in women without epilepsy were excluded. EURAP registry: potential overlap. |
| Tomson (Levetiracetam), 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 levetiracetam 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. |
599 / 2514 | Overlapping/Update: (Major) malfo as a whole: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016), Martinez 2018, Tomson 2011 => Not reported here (use of Battino 2024 for these outcomes). |
| Trivedi (Levetiracetam) (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 levetiracetam 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. |
63 / 48 | Study design partly completed with cites source Thomas et al., 2017. |
| Trivedi (Levetiracetam) (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 levetiracetam 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. |
63 / 178 | Study design partly completed with cites source Thomas et al., 2017. |
| Vajda (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2013 |
Australia 1999 - 2013 |
Pregnant women with epilepsy whether treated with antiepileptic drugs or left untreated or pregnant women taking antiepileptic drugs for other purposes. | Offsprings from women with epilepsy exposed to levetiracetam 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 from women with epilepsy exposed to lamotrigine in monotherapy in at least the first trimester of pregnancy. |
63 / 315 | Women taking AED for epilepsy are in majority (more than 90%). Vajda 2019 provides the most recent update for major malformations results for this register. Specific malformations results are extracted from the review by Weston et al. 2016. |
| Vajda (Levetiracetam) (Controls unexposed, sick), 2013 |
Australia 1999 - 2013 |
Pregnant women with epilepsy whether treated with antiepileptic drugs or left untreated or pregnant women taking antiepileptic drugs for other purposes. | Offsprings from women with epilepsy exposed to levetiracetam 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 from women with epilepsy not exposed to antiepileptic drugs in at least the first trimester of pregnancy. |
63 / 147 | Women taking AED for epilepsy are in majority (more than 90%). Vajda 2019 provides the most recent update for malformations results for this register. |
| Vajda a (Levetiracetam) (Controls exposed to LTG), 2024 |
Australia 1999 - 2023 |
Women with epilepsy (WWE), with voluntary inclusion, with known outcomes but in which that outcome was unknown at the time of the pregnancy’s enrolment. | Women with epilepsy exposed to Levetiracetam monotherapy during pregnancy. |
exposed to other treatment, sick
Women with epilepsy exposed to lamotrigine monotherapy during pregnancy. |
257 / 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. |
| Vajda a (Levetiracetam) (Controls unexposed sick), 2024 |
Australia 1999 - 2023 |
Women with epilepsy (WWE), with voluntary inclusion, with known outcomes but in which that outcome was unknown at the time of the pregnancy’s enrolment. | Women with epilepsy exposed to levetiracetam monotherapy during pregnancy. |
unexposed, sick
Women with epilepsy unexposed to antiseizure medication during pregnancy. |
257 / 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. |
| Vajda b (Levetiracetam) (Epilepsy) (Controls exposed to Lamotrigine, sick), 2024 |
Australia 1999 - 2022 |
Pregnant women with epilepsy collected in the Raoul Wallenberg Australian Pregnancy Register of Antiepileptic Drugs between 1999 and mid- 2022. | Women with epilepsy exposed to levetiracetam in monotherapy in early pregnancy. |
exposed to other treatment, sick
Women with epilepsy exposed to lamotrigine in monotherapy in early pregnancy. |
187 / 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. |
| Vajda b (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2024 |
Australia 1999 - 2022 |
Pregnant women with epilepsy collected in the Raoul Wallenberg Australian Pregnancy Register of Antiepileptic Drugs between 1999 and mid- 2022. | Women with epilepsy exposed to levetiracetam in monotherapy in early pregnancy. |
unexposed, sick
Women with epilepsy not treated with antiepileptic drugs in early pregnancy. |
187 / 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. |
| Van Marter (Levetiracetam) (Controls unexposed, disease free), 2021 |
US 2012 - 2016 |
Pregnant (gestational age of 20 weeks or less) women with epilepsy and healthy women who gave birth while enrolled in the study and their children who were enrolled at birth were included in the analysis population. | Children of pregnant women with epilepsy with exposure to levetiracetam monotherapy based on the mother’s prescribed antiepileptic drug at the time of enrollment. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Children of healthy pregnant women. |
97 / 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. |
| Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 |
US 2012 - 2016 |
Pregnant (gestational age of 20 weeks or less) women with epilepsy and healthy women who gave birth while enrolled in the study and their children who were enrolled at birth were included in the analysis population. | Children of pregnant women with epilepsy with exposure to levetiracetam monotherapy based on the mother’s prescribed antiepileptic drug at the time of enrollment. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children of pregnant women with epilepsy without prescribed antiepileptic drug at the time of enrollment. |
97 / 15 | 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. |
| Veiby (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to levetiracetam 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. |
114 / 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 (Levetiracetam) (Controls unexposed, disease free), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to levetiracetam 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. |
114 / 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 (Levetiracetam) (Controls unexposed, sick), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to levetiracetam 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. |
114 / 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 (Levetiracetam) (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 levetiracetam 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. |
7 / 8 | Study design partly completed with a previous article of Videman 2016. |
| Videman (Levetiracetam) (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 levetiracetam 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. |
7 / 67 | Study design partly completed with a previous article of Videman 2016. |
| Wiggs, 2024 |
Sweden 1996 - 2016 |
Singleton children born to women with epilepsy diagnosed before conception in Sweden between January 1, 1996, and December 31, 2016. | Children born to women with a recent epilepsy diagnosis who reported the use of Levetiracetam monotherapy at their first antenatal visit (8th-12th week of pregnancy). |
unexposed, sick
Children whose mothers had a recent diagnosis of epilepsy but who did not report the use of any antiseizure medications (ASMs) at their first antenatal visit. |
185 / 9364 | Overlapping: Razaz 2017 totally included in this study. Use of data in children born to women with a recent diagnosis of epilepsy prior to conception and with single antiseizure medication exposure. Total number of unexposed group based on eTable 3. |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|
7 studies, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.
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