| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| Battino (Epilepsy), 2024 |
Worldwide (47 countries) 1999 - 2022 |
Pregnant women with epilepsy exposed to antiseizure medications at the time of conception and enrolled within the 16th week of gestation, where fetal outcome had not yet been determined. | Pregnant women with epilepsy exposed to Pregabalin monotherapy at the time of conception. |
exposed to other treatment, sick
Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception. |
7 / 3584 | Overlapping/Update: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) and Tomson 2011 => Use of Battino 2024 for the 8 (plus 16 in eSupp) ASM monotherapies studied here. |
| Bjørk (Controls exposed to Lamotrigine, sick) (Mixed indications), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies in mothers filling at least one pregabalin 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 mothers filling at least one lamotrigine monotherapy prescription from her last menstrual period until birth. |
1666 / 7950 | Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up. |
| Bjørk (Controls unexposed NOS) (Mixed indications), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies in mothers filling at least one pregabalin 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. |
1666 / 4463879 | Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up. |
| Bjørk (Controls unexposed, sick) (Mixed indications), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies in mothers filling at least one pregabalin 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. |
1666 / 21634 | Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up. |
| Blotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019 |
France 2011 - 2015 |
All pregnancies ending between the study period with at least 20 weeks of gestation | Pregnancies exposed to pregabalin monotherapy between 1 month before and 2 months after the beginning of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnancies exposed to lamotrigine monotherapy between 1 month before and 2 months after the beginning of pregnancy. |
1671 / 2997 | Authors excluded twin pregnancies and pregnancies with a chromosomal abnormality identified. Less than 90% of exposed pregnancies have a proxy for epilepsy. Publication's OR were not kept when lower limit of the confidence interval or OR equal to 0. |
| Blotière (Controls unexposed NOS) (Other indications), 2019 |
France 2011 - 2015 |
All pregnancies ending between the study period with at least 20 weeks of gestation | Pregnancies exposed to pregabalin monotherapy between 1 month before and 2 months after the beginning of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnancies with no reimbursement for antiepileptic drugs. |
1671 / 1875733 | Authors excluded twin pregnancies and pregnancies with a chromosomal abnormality identified. Less than 10% of exposed pregnancies have a proxy for epilepsy. Publication's OR were not kept when lower limit of the confidence interval or OR equal to 0. |
| Christensen (All indications) (Controls exposed to LTG), 2024 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 |
All live-born singletons born in the included countries during the study periods. | Children of mothers who had redeemed at least one prescription of Pregabalin 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). |
2214 / 8756 | Overlapping: For LBW and SGA: Same databases, overlap of study period: Christensen 2024 totally included Kilic 2014 and has a better period of exposure than Dudukina 2023 => use of Christensen 2024 for these outcomes. |
| Christensen (All indications) (Controls unexposed, general population), 2024 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 |
All live-born singletons born in the included countries during the study periods. | Children of mothers who had redeemed at least one prescription of Pregabalin monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period). |
unexposed (general population or NOS)
Children of mothers who had not redeemed prescription of anti-seizure medication. |
2214 / 4467848 | Overlapping: For LBW and SGA: Same databases, overlap of study period: Christensen 2024 totally included Kilic 2014 and has a better period of exposure than Dudukina 2023 => use of Christensen 2024 for these outcomes. |
| Coste (Controls exposed to Lamotrigine, sick) (Mixed indications), 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 pregabalin monotherapy indicated for the treatment of epilepsy and migraine 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. |
1627 / 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 (Controls unexposed, NOS) (Mixed indications), 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 pregabalin monotherapy indicated for the treatment of epilepsy and neuropathic pain 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. |
1627 / 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 (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 pregabalin 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. |
120 / 5288 | |
| Dreier (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 pregabalin 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. |
120 / 22203 | |
| Dudukina (Controls exposed to LTG) (Mixed indications), 2023 |
Denmark, Finland, Norway, and Sweden. 2005 - 2016 |
All pregnancies (ending in live births or stillbirths) identified in the respective administrative registries from 2005 to 2015 in Denmark, Finland, and Norway and all pregnancies identified from 2006 to 2016 in Sweden. | At least one dispensing of pregabalin monotherapy (no dispensing for any other antipileptic drug) from last menstrual period (LMP) -90 days to LMP 97 days (first trimester) or any trimester to treat epilepsy, generalized anxiety disorder (GAD), and neuropathic pain. |
exposed to other treatment, sick
At least one dispensing of lamotrigine monotherapy (no dispensing for any other antipileptic drug) from last menstrual period (LMP) -90 days to LMP 97 days (first trimester) or any trimester. |
2332 / 7005 | Overlapping: Dudukina 2023 included in Bjork 2022 (for ASD and Cognitive disorders) and in Christensen 2024 (for LBW/SGA/Microcephaly), that have a better period of exposure => Use of Bjork and Christensen. Use of sensitivity analysis for monotherapy. |
| Dudukina (Controls unexposed, NOS) (Mixed indications), 2023 |
Denmark, Finland, Norway, and Sweden. 2005 - 2016 |
All pregnancies (ending in live births or stillbirths) identified in the respective administrative registries from 2005 to 2015 in Denmark, Finland, and Norway and all pregnancies identified from 2006 to 2016 in Sweden. | At least one dispensing of pregabalin monotherapy (no dispensing for any other antiepileptic drug) from last menstrual period (LMP) -90 days to LMP 97 days (first trimester) or any trimester to treat epilepsy, generalized anxiety disorder (GAD), and neuropathic pain. |
unexposed (general population or NOS)
Pregnancies without dispensing for pregabalin monotherapy or other antiepileptic drugs including lamotrigine, or duloxetine during the first trimester or any trimester. |
2332 / 3063173 | Overlapping: Dudukina 2023 included in Bjork 2022 (for ASD and Cognitive disorders) and in Christensen 2024 (for LBW/SGA/Microcephaly), that have a better period of exposure => Use of Bjork and Christensen. Use of sensitivity analysis for monotherapy. |
| Källén (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013 |
Swedish 1996 - 2011 |
Nearly all births in Sweden during the study period (1,575,847) are registered in The Swedish Medical Birth Register. | Infants whose mothers used pregabalin in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Infants whose mothers used lamotrigine in monotherapy in early pregnancy. |
111 / 1084 | Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply. |
| Källén (Controls unexposed, NOS) (Indications NOS), 2013 |
Swedish 1996 - 2011 |
Nearly all births in Sweden during the study period (1,575,847) are registered in The Swedish Medical Birth Register. | Infants whose mothers used pregabalin in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Infants in population whose mothers used at least one of a central nervous system active drugs (less than 3%) or weren't exposed in early pregnancy. |
111 / 1575847 | Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply. |
| Kaskal (Indications NOS), 2024 |
Turkey 2013 - 2022 |
Pregnancies in patients who used pregabalin medication during any stage of their pregnancy between 2013–2022. | Pregnant women who had taken pregabalin during pregnancy. |
unexposed (general population or NOS)
Pregnant women who did not use pregabalin, who applied to pharmacology outpatient clinic and were exposed to drugs in the lower-risk category such as penicillin group antibiotics and paracetamol-like analgesics. |
31 / 93 | OR provided by authors not consistent with raw data were not reported. |
| Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 |
Denmark 1997 - 2008 |
All singleton live-born children in Denmark during the study period. | Children whose mothers have been exposed to pregabalin in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children whose mothers have been exposed to lamotrigine in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. |
13 / 880 | Less than 90% of women are epileptic. Overlapping: For LBW and SGA: Kilic 2014 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes. |
| Kilic (Controls unexposed NOS) (Mixed indications), 2014 |
Denmark 1997 - 2008 |
All singleton live-born children in Denmark during the study period. | Children whose mothers have been exposed to pregabalin in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Children whose mothers haven't been exposed to antiepileptic drugs 30 days before the estimated day of conception to the day of birth. |
13 / 676834 | Less than 90% of women are epileptic. Overlapping: For LBW and SGA: Kilic 2014 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes. |
| Kilic (Controls unexposed, sick) (Mixed indications), 2014 |
Denmark 1997 - 2008 |
All singleton live-born children in Denmark during the study period. | Children whose mothers have been exposed to pregabalin in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children whose mothers have an epilepsy diagnosis and haven't been exposed to antiepileptic drugs 30 days before the estimated day of conception to the day of birth. |
13 / 5296 | Less than 90% of women are epileptic. Overlapping: For LBW and SGA: Kilic 2014 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes. |
| Madley-Dowd_SE (Pregabalin) (Controls exposed to LTG) (Mixed indications), 2024 |
Sweden 1995 - 2020 |
All liveborn children born between July 1, 1995, and December 31, 2020. | Fetal exposure to Pregabalin monotherapy for any indications 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 any indications 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. |
1307 / 5035 | Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the e-Supp pdf (Table S1; S2; S9) and excel (Figure S9 – Active comparator Analysis). |
| Madley-Dowd_SE (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024 |
Sweden 1995 - 2020 |
All liveborn children born between July 1, 1995, and December 31, 2020. | Fetal exposure to Pregabalin monotherapy for any indications 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 (general population or NOS)
No fetal exposure to antiseizure medication at any time during the pregnancy period. |
1307 / 2651210 | Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the e-Supp pdf (Table S1; S2 and S6). |
| Madley-Dowd_SE (Pregabalin) (Controls unexposed, sibling) (Mixed indications), 2024 |
Sweden 1995 - 2020 |
All liveborn children born between July 1, 1995, and December 31, 2020. | Siblings with fetal exposure to Pregabalin monotherapy for any indications 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. |
sibling
Discordant siblings without fetal exposure to antiseizure medication at any time during the pregnancy period. |
-9 / -9 | Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the e-Supp pdf (Table S8) and excel (Figure S8 – Discordant Sibling Analysis). |
| Madley-Dowd_UK (Pregabalin) (Controls exposed to LTG) (Mixed indications), 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 Pregabalin monotherapy for any indications at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period. |
exposed to other treatment, sick
Fetal exposure to Lamotrigine monotherapy for any indications at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period. |
408 / 939 | Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the e-Supp pdf (Table S1, S2 and S9) and excel (Figure S9 – Active Comparator Analysis). |
| Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 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 Pregabalin monotherapy for any indications at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period. |
unexposed (general population or NOS)
No fetal exposure to antiseizure medication at any time during the pregnancy period. |
408 / 514066 | Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the e-Supp pdf (Table S1, S2 and S6). |
| Madley-Dowd_UK (Pregabalin) (Controls unexposed, sibling) (Mixed indications), 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. | Siblings with fetal exposure to Pregabalin monotherapy for any indications at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period. |
sibling
Discordant siblings without fetal exposure to antiseizure medication at any time during the pregnancy period. |
-9 / -9 | Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the e-Supp pdf (Table S8) and excel (Figure S8 – Discordant Sibling Analysis). |
| Margulis (Pregabalin) (Indications other than epilepsy), 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 pregabalin monotherapy at any time during pregnancy. |
exposed to other treatment, sick
Infants whose mothers reported use of lamotrigine at any time during pregnancy. |
499 / 1812 | Monotherapy results available in e-Supp tables (S3 File). For SGA and microcephaly: partial overlapping between Margulis 2019 and Christensen 2024 (7 years in common and 14 years not in common) => the 2 studies were kept. |
| Patorno_MAX and MaketScan (Other indications), 2017 |
USA 2000 - 2010 |
All pregnancies in women 12 to 55 years of age that resulted in a live-born infant between the study period for Medicaid beneficiaries. They have continuous Medicaid eligibility from 90 days before the estimated last menstrual period until 1 month after delivery. And commercially insured patients in Marketscan. | Infants born to women exposed to pregabalin (at least one filled prescription during the first trimester of pregnancy) but not to other anticonvulsant drugs during the 3 months before the start of pregnancy or during the first trimester. |
unexposed (general population or NOS)
Infants born to women who had no dispensings for pregabalin or other anticonvulsant medications during the 3 months before the start of pregnancy or during the first trimester. |
471 / 1322955 | Reported results are pooled OR of 1st trimester monotherapy of the 2 cohorts (MAX and Market scan). Less than 10% of women have epilepsy. Study design partly completed with cited source [5]. |
| Razaz (Epilepsy), 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 Pregabalin 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. |
89 / 19043 | |
| The NAAED (Controls exposed to LTG) (Indications NOS), 2023 |
North America and Canada 1997 - 2022 |
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 Pregabalin as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Infants of pregnant women who used lamotrigine as monotherapy, during the first trimester. |
62 / 2461 | Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry website. Overlapping/update with Hernández-Díaz et al. 2012 and previous website reports. Use of internal control. |
| The NAAED (Controls unexposed, disease free) (Indications NOS), 2023 |
North America and Canada 1997 - 2022 |
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 Pregabalin as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Infants of pregnant women, not taking an antiepileptic drug and without epilepsy, who were recruited from among the friends and family members of the enrolled women taking an antiepileptic drug. |
62 / 1311 | Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry website. Overlapping/update with Hernández-Díaz et al. 2012 and previous website reports. Use of internal control. |
| Vajda (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 pregabalin 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. |
1 / 406 | Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013. Malformations results presented in Jazayeri 2018 are already included in this publication. |
| Vajda (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 pregabalin 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. |
1 / 176 | Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013. Malformations results presented in Jazayeri 2018 are already included in this publication. |
| Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to pregabalin as monotherapy indicated for their mothers' epilepsy or other indications. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children exposed prenatally to lamotrigine as monotherapy indicated for their mothers' epilepsy or other indications. |
30 / 833 | Less than 90% of women are treated with Lamotrigine for epilepsy and indications for Pregabalin is unknown. |
| Veiby (Controls unexposed, disease free) (Mixed indications), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to pregabalin as monotherapy indicated for their mothers' epilepsy or other indications. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
All unexposed children born to women without epilepsy. |
30 / 771412 | Indications for Pregabalin is unknown. |
| Veiby (Controls unexposed, sick) (Mixed indications), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to pregabalin as monotherapy indicated for their mothers' epilepsy or other indications. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children born to women with a history of epilepsy but no antiepileptic drug treatment during pregnancy. |
30 / 3773 | Indications for Pregabalin is unknown. |
| Winterfeld (Other indications), 2016 |
Worldwide (France, United Kingdom, Italy, Finland, Switzerland, the Netherlands, and Turkey) 2004 - 2013 |
Women who themselves or whose physician contacted one of the centers. | Pregnancies in patients with pregabalin monotherapy exposure during the first trimester 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 who were not exposed to any medications known to be teratogenic or to any antiepileptic drugs. |
19 / 656 | Study design completed with cited source [14]. |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|
1 study, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.
-
About
-
Master protocol
-
Browse exposition
-
RSS
-
Made with in Lyon
-
Contact us
-
Privacy policy
-
