| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| Adams (Phenobarbital), 2022 |
Boston, USA 1983-1993 1996-2000 |
Pregnant women with seizure disorders without tonic-clonic seizures during pregnancy recruited through a surveillance study conducted during the first period. Then during the second study period, subjects were identified through referrals from local neurologists, pediatricians, and obstetrician/gynecologists and through a large health maintenance organization in the Boston area. | Children following gestational exposure to phenobarbital monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children born to antiseizure medication-unexposed women with seizure disorders. |
34 / 34 | Pregnant women with any exposure to other agents known to be of teratogenic concern during pregnancy were excluded. Additionally, children who were born prematurely were excluded from the study. |
| Al Bunyan (Phenobarbital), 1999 |
Saudi Arabia 1985 - 1994 |
Pregnant epileptic patients followed up in the neurology clinics during the study period. | Children whose epileptic mothers were exposed to phenobarbital monotherapy during the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children whose epileptic mothers did not take antiepileptic drugs during the pregnancy because their seizures were in remission and as a personal preference. |
2 / 10 | The control group with the data of historical controls in Saudi Arabia isn't an adequate control group. |
| Barroso (Phenobarbital), 2015 |
Brazil 2000 - 2010 |
Epileptic pregnant women with a single fetus and with a pre-gestational diagnosis who made use of antiepileptic drugs during the pregnancy were included in the study. | Newborns of epileptic parturients receiving phenobarbital monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Newborns of nonepileptic parturients who had deliveries immediately before and after the delivery of epileptic parturients. |
32 / 316 | |
| Battino (Phenobarbital), 1992 |
Milan 1977 - 1989 |
Epileptic patients were followed prospectively from the beginning of the pregnancy during the study period in the context of the Milan Collaborative Study on Epilepsy and Pregnancy. | Offspring of epileptic mothers treated with phenobarbital monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offspring of epileptic mothers with no antiepileptic drugs administered. |
60 / 9 | The results for the malformations are already available in Canger 1999 (a more recent publication with a larger exposed group) except for minor malformations. |
| Battino (Phenobarbital), 1999 |
Japan, Italy and Canada 1978 - 1991 |
Female patient of childbearing age with epilepsy who visited clinics and who consented to be followed throughout their pregnancy. The data from three studies carried out in Canada, Japan and Italy were pooled. | Infants whose epileptic mothers were exposed to phenobarbital in monotherapy until term. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infants whose epileptic mothers were not treated with antiepileptic drugs during pregnancy. |
88 / 36 | Each country has its own reference standards, then the data from the different countries are pooled. Exposition period deducted from Kaneko 1999. |
| Bech (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Other indications), 2018 |
Denmark 2005 - 2008 |
All births in Denmark were identified during the study period in the Danish Medical Birth Register and only offspring of mothers exposed to antiepileptic drugs were included. | Singleton offspring of mothers exposed to phenobarbital monotherapy within 90 days prior to conception to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Singleton offspring of mothers exposed to lamotrigine monotherapy within 90 days prior to conception to birth. |
11 / 290 | |
| Bech (Phenobarbital) (Controls unexposed, sick) (Other indications), 2018 |
Denmark 2005 - 2008 |
All births in Denmark were identified during the study period in the Danish Medical Birth Register and only offspring of mothers exposed to antiepileptic drugs were included. | Singleton offspring of mothers exposed to phenobarbital monotherapy within 90 days prior to conception to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Singleton offspring of mothers exposed to antiepileptic drugs at any time but not during pregnancy. |
11 / 434 | |
| Bjørk (Phenobarbital) (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 phenobarbital 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. |
175 / 7950 | Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up. Intellectual disability not implemented owing to personal data protection restrictions on publishing cell counts less than 5. |
| Bjørk (Phenobarbital) (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 phenobarbital 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. |
175 / 4463879 | Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up. Intellectual disability not implemented owing to personal data protection restrictions on publishing cell counts less than 5. |
| Bjørk (Phenobarbital) (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 phenobarbital 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. |
175 / 21634 | Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up. Intellectual disability not implemented owing to personal data protection restrictions on publishing cell counts less than 5. |
| Blotière (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 |
France 2011 - 2015 |
All pregnancies ending between the study period with at least 20 weeks of gestation | Pregnancies exposed to phenobarbital 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. |
80 / 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 (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 |
France 2011 - 2015 |
All pregnancies ending between the study period with at least 20 weeks of gestation | Pregnancies exposed to phenobarbital 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. |
80 / 1875733 | Authors excluded twin pregnancies and pregnancies with a chromosomal abnormality identified. Less than 90% of exposed pregnancies have a proxy for epilepsy. Publication's OR were not kept when lower limit of the confidence interval or OR equal to 0. |
| Burja (Phenobarbital) (Controls unexposed, disease free), 2006 |
Slovenia 1998 - 2002 |
Newborns and their mothers who gave birth at the Maribor Department of Obstetric and Perinatology during the study period. | Newborn in women diagnosed as having epilepsy who had taken phenobarbital in monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Newborn in a randomized sample of pregnant women who had received no prescription at all (with the only diagnosis 'vaginal delivery') in the same period. |
1 / 211 | |
| Burja (Phenobarbital) (Controls unexposed, sick), 2006 |
Slovenia 1998 - 2002 |
Newborns and their mothers who gave birth at the Maribor Department of Obstetric and Perinatology during the study period. | Newborn in women diagnosed as having epilepsy who had taken phenobarbital in monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Newborn in women diagnosed as having epilepsy who didn't take antiepileptic drugs during pregnancy. |
1 / 32 | |
| Canger (Phenobarbital), 1999 |
Italy 1977 - 1996 |
517 women with epilepsy reffered to the study mainly from the Milan metropolitan and suburban areas or other Italian regions. They were followed up during the preconceptional period and/or from the beginning of pregnancy. | Infants of epileptic mothers exposed to phenobarbital monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infants of epileptic mothers unexposed to antiepileptic drugs during pregnancy. |
83 / 25 | Only the first pregnancies of each of the 517 women were included in the analysis. |
| Cassina (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Other indications), 2013 |
Italy 2000 - 2008 |
695 pregnant epileptic or non-epileptic women exposed to antiepileptic drugs therapy had been registered during the study period. | Children whose mothers were treated with phenobarbital in monotherapy between the 5th and the 14th week after their last menstrual period in order to control non-epileptic disorders. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children whose mothers were exposed to lamotrigine in monotherapy between the 5th and the 14th week after their last menstrual period in order to control non-epileptic disorders. |
6 / 31 | Chromosomal anomalies and genetic syndromes were excluded. |
| Cassina (Phenobarbital) (Controls unexposed, disease free) (Other indications), 2013 |
Italy 2000 - 2008 |
695 pregnant epileptic or non-epileptic women exposed to antiepileptic drugs therapy had been registered during the study period. | Children whose mothers were treated with phenobarbital in monotherapy between the 5th and the 14th week after their last menstrual period in order to control non-epileptic disorders. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Healthy pregnant women randomly selected among patients who contacted the Teratology Information Services during their pregnancy with regard to exposure to agents known not to be teratogenic (i.e. paracetamol, hair dying, etc.) during a similar time frame. |
6 / 867 | Chromosomal anomalies and genetic syndromes were excluded. |
| Coste (Phenobarbital) (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 phenobarbital 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 indicated for the treatment of epilepsy and bipolar disorder with at least one dispensing between the month preceding onset of pregnancy and its end. |
84 / 2813 | 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. |
| Coste (Phenobarbital) (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 phenobarbital 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. |
84 / 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. |
| D'Souza (Phenobarbital) (Controls unexposed, disease free), 1991 |
UK 1980 - 1982 |
A group of pregnant mothers each of whom gave a history of grand mal epilepsy and who were referred to the antenatal clinic during the study period. | Infants born to epileptic mothers treated with phenobarbitone alone throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Infants born to mothers without epilepsy not taking any drugs regularly. |
4 / 62 | |
| D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 |
UK 1980 - 1982 |
A group of pregnant mothers each of whom gave a history of grand mal epilepsy and who were referred to the antenatal clinic during the study period. | Infants born to epileptic mothers treated with phenobarbital alone throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infants whose mothers had a history of epilepsy but received no drugs during pregnancy. |
4 / 8 | |
| Dean (Phenobarbital), 2002 |
Scotland 1976 - 2000 |
Children of mothers taking antiepileptic drugs in pregnancy during the study period were ascertained from hospital obstetric records. | Children whose mothers took phenobarbital monotherapy in pregnancy and continued beyond the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Sibs of exposed cases not exposed to antiepileptic drugs in utero. Either the mothers had epilepsy or the child was born before epilepsy developed. |
61 / 38 | The data for major congenital malformations include all pregnancies surviving into the second trimester. The vast majority of the mothers were treated for epilepsy. Developmental delay is already assessed in Dean et al. 2007. |
| Dean (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2007 |
Scotland 1976 - 2002 |
Children of mothers who were prescribed antiepileptic drugs during a pregnancy between the study period were identified from hospital records. | Children whose epileptic mothers were exposed to phenobarbital 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 monotherapy during pregnancy. |
50 / 4 | A previous publication (Dean 2002) gives a better review of the major malformations (includes dead malformed fetuses). |
| Dean (Phenobarbital) (Controls unexposed, sick), 2007 |
Scotland 1976 - 2002 |
Children of mothers who were prescribed antiepileptic drugs during a pregnancy between the study period were identified from hospital records. | Children whose epileptic mothers were exposed to phenobarbital 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 not exposed during pregnancy. |
50 / 46 | A previous publication (Dean 2002) gives a better review of the major malformations. |
| Díaz-Romero (Phenobarbital), 1999 |
Mexico 1993 - 1996 |
Full-term eutrophic newborns of epileptic mothers who attended the Epilepsy Clinic of the National Institute of Perinatology, a third-level gyneco-obstetric center in Mexico City during the study period. | Full-term eutrophic newborns of epileptic mothers exposed to only phenobarbital during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offspring of epileptic women without seizures during pregnancy and without exposure to any drug. |
2 / 8 | All newborns in the intensive care unit, and those with congenital malformations with a different specific recognizable etiology were excluded. |
| Dravet (Phenobarbital), 1992 |
France 1984 - 1988 |
Letters and notification forms were mailed to health care practitioners in the region to identify before any information was available about the fetus all pregnant women with epilepsy, treated or untreated with antiepileptic drugs. | Infants of mothers with epilepsy treated with phenobarbital alone during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infants of women with epilepsy who did not receive any antiepileptic drugs during pregnancy. |
72 / 14 | The number of unknown head circumference decrease the exposed sample size in the outcome result. |
| Elkjaer (Phenobarbital), 2018 |
Denmark 1997 - 2006 |
All children born alive in Denmark between the study period. | Children with phenobarbital 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. |
86 / 477162 | There is no information about the exposure indication. |
| Endo (Phenobarbital) (Controls unexposed, disease free), 2004 |
Japan 1991 - 2000 |
Newborn of mothers with epilepsy at Yokohama City University Hospital during the study period and total deliveries excluding epilepsy cases of 1991 and 1992 at the same hospital. | Newborns of epileptic mothers who take phenobarbital monotherapy for epilepsy throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Newborns of nonepileptic mothers. |
10 / 656 | 30 (83.3%) cases of 36 pregnancies continued taking drugs throughout pregnancy. Three (8.3%) patients discontinued after week 13 of pregnancy. Some results do not coincide between table 1 and table 2 and are therefore not reported. |
| Endo (Phenobarbital) (Controls unexposed, sick), 2004 |
Japan 1991 - 2000 |
Newborn of mothers with epilepsy at Yokohama City University Hospital during the study period and total deliveries excluding epilepsy cases of 1991 and 1992 at the same hospital. | Newborns of epileptic mothers who take phenobarbital monotherapy for epilepsy throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Newborns of epileptic mothers who had not taken any antiepileptic drugs. |
10 / 1 | 30 (83.3%) cases of 36 pregnancies continued taking drugs throughout pregnancy. Three (8.3%) patients discontinued after week 13 of pregnancy. Some results do not coincide between table 1 and table 2 and are therefore not reported. |
| Fedrick (Phenobarbital), 1973 |
UK 1966 - 1970 |
All births (whether hospital or domiciliary) and all deaths of residents in Oxfordshire and most of Berkshire from all women coded as having epilepsy and who delivered in the study period. | Infants of epileptic mothers exposed to phenobarbital alone in the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infants of epileptic mothers not taking drugs. |
41 / 19 | The control series with three control pregnancies resulting in livebirths chosen for each pregnancy resulting in a livebirth to an epileptic mother cannot be used for defect control per antiepileptic drugs types. |
| Hernández-Díaz (Phenobarbital), 2017 |
United States and Canada 1997 - 2017 |
Singleton, nonmalformed liveborn infants whose mothers had complete follow-up data and have taken antiepileptic drugs at some point during their pregnancies. | Infants born to women who used phenobarbital in monotherapy throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Infants born to women who used lamotrigine in monotherapy throughout pregnancy. |
178 / 1799 | 'Most women used their AED throughout pregnancy. The exception was topiramate'. The main indications for AED were epilepsy (91%). |
| Hernández-Díaz (Phenobarbital) (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 phenobarbital 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). |
199 / 1562 | Total congenital malformations results are completely overlapped by the update on the registry website. Less than 90% of women are taking Lamotrigine for epilepsy. |
| Hernández-Díaz (Phenobarbital) (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 phenobarbital 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. |
199 / 442 | Total congenital malformations results are completely overlapped by the update on the registry website. |
| Holmes (Phenobarbital) (Controls unexposed, disease free), 2001 |
United States 1986 - 1993 |
128,049 pregnant women at delivery who gave birth to singleton in the labor and delivery suites during the study period. | Infants exposed in utero to phenobarbital in monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Infants unexposed in utero to any antiepileptic drugs born to women with no history of seizure and closest in time from the corresponding exposed children. |
64 / 508 | 9% are exposed for other indications (no specified per type of AED). |
| Holmes (Phenobarbital) (Controls unexposed, sick), 2001 |
United States 1986 - 1993 |
128,049 pregnant women at delivery who gave birth to singleton in the labor and delivery suites during the study period. | Infants exposed in utero to phenobarbital in monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infants unexposed in utero to any antiepileptic drugs born to women with a history of seizure. |
64 / 98 | 9% are exposed for other indications (no specified per type of AED). |
| Kaaja (Phenobarbital), 2003 |
Finland 1980 - 1998 |
All women with epilepsy regardless of whether they used antiepileptic drugs during the index pregnancy. | Infants whose epileptic mothers took phenobarbital 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. |
5 / 239 | |
| Källén (Phenobarbital) (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 phenobarbital 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. |
17 / 1084 | Indications for antiepileptic drugs are not specified. Wide 2004 outcomes' are already included in Källèn et al 2013 or are not compared to an adequate control group. Follow-up period known thanks to author's email reply. |
| Källén (Phenobarbital) (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 phenobarbital 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. |
17 / 1575847 | Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply. |
| Kaneko (Phenobarbital), 1999 |
Japan, Italy and Canada. 1978 - 1991 |
Female patient of childbearing age with epilepsy who visited clinics and who consented to be followed throughout their pregnancy. The data from three studies carried out in Canada, Japan and Italy were pooled. | Offspring whose epileptic mothers were under phenobarbital or methylphenobarbital monotherapy until term. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offspring from epileptic mothers without antiepileptic drug exposure until term. |
84 / 98 | Methylphenobarbital and Phenobarbital were considered as the same drug. Details about the design were completed thanks to Battino et al. 1999. Kaneko 1999 overlapped with Kaneko 1988, Oguni 1992, Dansky 1982, Canger 1999 and Battino 1992. |
| Kasradze (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2017 |
Georgia 2001 |
Women with epilepsy whose children had reached ages from 36 to 72 months at the time of the study and registered in the registry. | Children born to epileptic mothers exposed to phenobarbital monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children born to epileptic mothers exposed to lamotrigine monotherapy during pregnancy. |
3 / 3 | Children with major congenital malformations were excluded from the study. |
| Kasradze (Phenobarbital) (Controls unexposed, disease free), 2017 |
Georgia 2001 |
Women with epilepsy whose children had reached ages from 36 to 72 months at the time of the study and registered in the registry. | Children born to epileptic mothers exposed to phenobarbital monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Children born to mothers without epilepsy, with no antiepileptic drug or other drug treatment during pregnancy |
3 / 50 | Children with major congenital malformations were excluded from the study. |
| Katz (Phenobarbital), 2001 |
USA 1990 - 2000 |
The clinical histories of women with epilepsy cared for at the center, contributing 103 newborns during the study period. | Newborn of women with epilepsy exposed to phenobarbital monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Newborn of women with epilepsy exposed to lamotrigine monotherapy during pregnancy. |
5 / 3 | The analysis of developmental delay excluded the 20 pregnancies occurring within 1 year of chart review because of insufficient time to evaluate developmental milestones. |
| Kelly (Phenobarbital), 1984 |
USA 1977 - 1982 |
Women of childbearing age with epilepsy. | Children and older sibs born to study epileptic mothers receiving phenobarbital alone at the time they were enrolled. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children and older sibs born to study epileptic mothers not on anticonvulsant treatment at the time they were enrolled. |
13 / 21 | |
| Kilic (Phenobarbital) (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 phenobarbital 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. |
96 / 880 | Less than 90% of women are epileptic. |
| Kilic (Phenobarbital) (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 phenobarbital 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. |
96 / 676834 | Less than 90% of women are epileptic. |
| Kilic (Phenobarbital) (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 phenobarbital 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. |
96 / 5296 | Less than 90% of women are epileptic. |
| Kini (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2006 |
UK 1989 - 1999 |
375 children aged between 6 months and 16 years from 219 mothers with epilepsy exposed and not exposed to antiepileptic drugs during pregnancy attending epilepsy clinics or antenatal care between the study period. | Children exposed to phenobarbital monotherapy during pregnancy and with epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children exposed to lamotrigine monotherapy during pregnancy and with epileptic mothers. |
2 / 9 | Because we don't know the exact number of children exposed to lamotrigine and analyzed for malformations, this outcome cannot be reported here. |
| Kini (Phenobarbital) (Controls unexposed, sick), 2006 |
UK 1989 - 1999 |
375 children aged between 6 months and 16 years from 219 mothers with epilepsy exposed and not exposed to antiepileptic drugs during pregnancy attending epilepsy clinics or antenatal care between the study period. | Children exposed to phenobarbital monotherapy during pregnancy and with epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children not exposed to antiepileptic drugs during pregnancy and with epileptic mothers. |
2 / 101 | Because we don't know the exact number of children exposed to phenobarbital and analyzed for malformations, this outcome cannot be reported here. |
| Koch (Phenobarbital), 1996 |
Germany 1976 - 1983 |
Children born to epileptic women who had been treated during pregnancy with antiepileptic drug monotherapy of either primidone/phenobarbitone, phenytoin or valproic acid were studied in detail. The mothers were randomly recruited during their pregnancy from five obstetric departments within the city of Berlin. | Children born to epilepic mothers who had been exposed to phenobarbitone during fetal life. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Children born to mothers randomly recruited during their pregnancy from the same obstetric departments. |
4 / 65 | Primidone and phenobarbitone are regarded as the same drug for the authors. Study design partly completed with cited source [13]. |
| Lowe (Phenobarbital) (Controls unexposed, disease free), 1973 |
UK (Wales) 1965 - 1971 |
All the infants (31,877) born to women domiciled in Cardiff during the study period. | Infants born to women who gave a history of having had an epileptic seizure at any time in their lives and exposed to phenobarbital alone during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Infants born to women living in Cardiff who didn't gave a history of having had an epileptic seizure at any time in their lives. |
53 / 31632 | |
| Lowe (Phenobarbital) (Controls unexposed, sick), 1973 |
UK (Wales) 1965 - 1971 |
All the infants (31,877) born to women domiciled in Cardiff during the study period. | Infants born to women who gave a history of having had an epileptic seizure at any time in their lives and exposed to phenobarbital alone during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infants of mothers with a history of epilepsy but not on anticonvulsants. |
53 / 111 | |
| Miškov (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2016 |
Croatia 2003 - 2013 |
Pregnant women with epilepsy during the study period at the the Sestre milosrdnice University Hospital Center. | Pregnancies in women with epilepsy on phenobarbital monotherapy. (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 on lamotrigine monotherapy. |
3 / 37 | Includes all Miskov's 2010 outcomes. |
| Miškov (Phenobarbital) (Controls unexposed, disease free), 2016 |
Croatia 2003 - 2013 |
Pregnant women with epilepsy during the study period at the the Sestre milosrdnice University Hospital Center. | Pregnancies in women with epilepsy on phenobarbital monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Pregnancies in healthy controls. |
3 / 147 | Includes all Miskov's 2010 outcomes. |
| Miškov (Phenobarbital) (Controls unexposed, sick), 2016 |
Croatia 2003 - 2013 |
Pregnant women with epilepsy during the study period at the the Sestre milosrdnice University Hospital Center. | Pregnancies in women with epilepsy on phenobarbital monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnancies in women with epilepsy without antiepileptic drugs. |
3 / 4 | Includes all Miskov's 2010 outcomes. |
| Robert (Phenobarbital), 1986 |
France 1976 - 1983 |
148 infants born of epileptic women were identified from two sources: hospital records of women having had an EEG between 1976 and 1983 and 3 maternity with computerized records from 1979 - 1983. | Infants born from epileptic mothers exposed during the first trimester to phenobarbital in monotherapy. |
unexposed, sick
Infants born from epileptic mothers unexposed during the first trimester to any antiepileptic drugs. |
40 / 35 | |
| Samrén (Phenobarbital), 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 phenobarbital, mephobarbital or methylphenobarbital monotherapy at least during the first trimester of pregnancy |
unexposed, disease free
Children born to nonepileptic nonexposed women. |
178 / 2000 | Mephobarbital or methylphenobarbital are synonyms and pro-drugs that are mainly metabolized into phenobarbital. |
| Shankaran (Phenobarbital) (Other indications), 1996 |
USA Not specified. |
Surviving children discharge from the neonatal intensive care unit born to women in preterm labor (<35 weeks’ gestation) who participated in a study evaluating the effect of antenatal phenobarbital on neonatal intracranial hemorrhage. | Infants born to mothers who had received phenobarbital monotherapy before delivery in preterm labor (once intravenously, followed by 100 mg orally daily, until delivery). |
unexposed, sick
Infants born to mothers who did not received treatment before delivery in preterm labor. |
41 / 55 | This study was performed as the follow-up component of a randomized controlled trial. The psychomotor delay is already evaluated in Shankaran et al., 2002 as well as neonatal intracranial hemorrhage, cerebral palsy, hearing/visual impairment. |
| Shankaran (Phenobarbital) (Other indications), 2002 |
USA Not specified. |
All surviving infants who were born to women who were enrolled in an antenatal phenobarbital trial. | Infants born to mothers who had received phenobarbital monotherapy before delivery in preterm labor (once intravenously, followed by 100 mg orally daily, until delivery). |
unexposed, sick
Infants born to mothers who had received intravenously an infusion of normal saline solution and daily maintenance doses of placebo orally until delivery in preterm labor. |
226 / 210 | This study was performed as the follow-up component of a randomized controlled trial with infants <34 weeks of gestational age. |
| Steegers-Theunissen (Phenobarbital), 1994 |
Netherlands Not specified |
Epileptic and healthy control women visiting the outpatient departments were recruited before conception and just one singleton pregnancy per woman is studied. | Singleton of epileptic women exposed to phenobarbital monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Singleton of healthy women unexposed during pregnancy. |
12 / 106 | Women could only participate if they or any first-degree relative had no genetic disorder known to cause major congenital malformations, and if they were not under treatment for infectious, metabolic, endocrine or malignant diseases. |
| The NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022 |
North America and Canada 1997 - 2020 |
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 phenobarbital 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. |
200 / 2333 | Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry website. Indications not specified. |
| The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 |
North America and Canada 1997 - 2020 |
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 phenobarbital 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. |
200 / 1201 | Study design completed with Hernández-Díaz et al. 2012. Data from the NAAED registry website. Internal control group reported rather than the external (for relevance purpose). Indications not specified. Holmes' et al., 2004 malformations overlapped. |
| Thomas (Phenobarbital) (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 phenobarbitone 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. |
137 / 50 | Study design completed with Thomas et al., 2017. Keni's 2018 malformations results are already reported in this publication. |
| Thomas (Phenobarbital) (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 phenobarbital 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. |
129 / 319 | This external control group is only available in the 2017 publication. |
| Thomas (Phenobarbital) (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 phenobarbitone 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. |
137 / 340 | Study design completed with Thomas et al., 2017. Thomas et al., 2008 completely overlapped with this publication. |
| Thomas (Phenobarbitone), 2022 |
India 1998 - 2006 |
Children (13–21 years) of women with epilepsy (CWWE) who were 13 years old or older on 31 December 2019 and had undergone developmental assessment at one year. | Children of women with epilepsy (CWWE) exposed to Phenobarbitone monotherapy during pregnancy. |
unexposed, sick
Children of women with epilepsy (CWWE) not exposed to antiseizure medications during pregnancy. |
12 / 11 | Overlapping: Thomas 2022 included data on language and cognitive delay, also evaluated in Sreedharan et al., 2018; Thomas 2007 and Gopinath 2015, but with more exposed pregnancies, more relevant control group and older children => Use of Thomas 2022. |
| Thomas b (Phenobarbital), 2008 |
India 1998 - 2004 |
395 infants born to mothers with epilepsy enrolled in the preconception period or during early pregnancy before the fetal outcome is known. | Infants whose epileptic mothers were on phenobarbital monotherapy anytime during the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infants not prenatally exposed to antiepileptic drugs anytime during the pregnancy. |
41 / 32 | The Developmental Assessment Scale for Indian Infants (DASII) is an adaptation of the Bayley Scale of Infant Development standardized for Indian infants. |
| Titze (Phenobarbital) (Controls unexposed, disease free), 2008 |
Germany 1976 - 1984 |
Adolescents born during the study period from mothers randomly recruited during their pregnancy, were asked to participate if they had been followed up to 6 years of age. | Adolescents whose epileptic mothers were exposed to phenobarbital monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Adolescents from non-affected mothers. |
3 / 49 | |
| Titze (Phenobarbital) (Controls unexposed, sick), 2008 |
Germany 1976 - 1984 |
Adolescents born during the study period from mothers randomly recruited during their pregnancy, were asked to participate if they had been followed up to 6 years of age. | Adolescents whose epileptic mothers were exposed to phenobarbital monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Adolescents whose epileptic mothers weren't exposed to any antiepileptic drugs during pregnancy. |
3 / 13 | |
| Tomson (Phenobarbital), 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 phenobarbital 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. |
294 / 2514 | Martinez 2009 contains malformations results already included in this study. 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. |
| Tomson (Phenobarbital), 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 phenobarbital 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. |
260 / 1910 | Pregnancies that occurred in women without epilepsy were excluded. EURAP registry: potential overlap. |
| Trivedi (Phenobarbital) (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 phenobarbital 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. |
138 / 48 | Study design partly completed with cites source Thomas et al., 2017. |
| Vajda (Phenobarbital) (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 phenobarbitone 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. |
2 / 406 | Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2013 and 2014. Study design partly completed with Vajda 2013. |
| Vajda (Phenobarbital) (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 phenobarbitone 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. |
2 / 176 | Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2013 and 2014. Study design partly completed with Vajda 2013. |
| Van der Pol (Phenobarbital) (Controls unexposed, disease free), 1991 |
The Netherlands 1973 - 1981 |
During the study period, epileptic mothers were delivered of a live-born infant at the hospital. Infants were selected with the following criteria: antiepileptic medication phenobarbital and/or carbamazepine or none; no evidence of intrauterine infection or chromosomal abnormalities and absence of additional drug exposure. | Children born to epileptic mothers exposed to phenobarbital only throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Children of nonepileptic mothers selected from singletons born in the same period. |
13 / 61 | |
| Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 |
The Netherlands 1973 - 1981 |
During the study period, epileptic mothers were delivered of a live-born infant at the hospital. Infants were selected with the following criteria: antiepileptic medication phenobarbital and/or carbamazepine or none; no evidence of intrauterine infection or chromosomal abnormalities and absence of additional drug exposure. | Children born to epileptic mothers exposed to phenobarbital only throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children born to epileptic mothers not exposed to antiepileptic medication. |
13 / 24 | |
| Veiby (Phenobarbital) (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 phenobarbital 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. |
27 / 833 | Exposure to antiepileptic drugs for the strict indication of epilepsy cannot be considered for the results of specific malformations. Thus, less than 90% of women are treated with Phenobarbital and Lamotrigine for epilepsy (Mixed indications). |
| Veiby (Phenobarbital) (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 phenobarbital 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. |
27 / 771412 | Less than 90% of women are treated with Phenobarbital for epilepsy (Mixed indications). |
| Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to phenobarbital 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. |
27 / 3773 | Exposure to antiepileptic drugs for the strict indication of epilepsy cannot be considered for the results of specific malformations. Thus, less than 90% of women are treated with Phenobarbital for epilepsy (Mixed indications). |
| Waters (Phenobarbital) (Controls unexposed, disease free), 1994 |
USA 1987 - 1990 |
Women with epilepsy in a high risk obstetric clinic. | Infants born to epileptic mothers exposed to phenobarbital during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Infants born to nonepileptic mothers selected from a computer-generated list of all women who gave birth in the same facility during this period. |
21 / 355 | Mothers who abused alcohol and other drugs were excluded from both patient ad control groups. |
| Waters (Phenobarbital) (Controls unexposed, sick), 1994 |
USA 1987 - 1990 |
Women with epilepsy in a high risk obstetric clinic. | Infants born to epileptic mothers exposed to phenobarbital during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnancies in women with epilepsy in which there was no exposure to antiepileptic drugs. |
21 / 15 | Mothers who abused alcohol and other drugs were excluded from both patient ad control groups. |
| Yerby (Phenobarbital), 1992 |
USA Not specified. |
Women with a diagnosis of epilepsy determined by a neurologist, antiepileptic drug use, and active planning for pregnancy or early (first trimester) pregnancy. | Infants of mothers with epilepsy treated by phenobarbital monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Infants of women without a chronic illness or a personal or family history of epilepsy. |
10 / 46 | Women were excluded if they had another chronic illness and were not compliant. |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|---|---|---|---|---|
| Bànhidy (Phenobarbital), 2011 |
Hungary 1980 - 1996 |
Children affected with congenital abnormalities and who had mothers with medically recorded epilepsy. | Newborn infants without congenital abnormality and who had mothers with medically recorded epilepsy. | 95 / 90 | Congenital abnormalities syndromes caused by major mutant genes or chromosomal aberrations with preconceptional origin were excluded. Exposure period completed with Czeizel 1992. |
| Thomas a (Phenobarbital), 2008 |
India 1998 - 2004 |
Infants with cardiac malformation defined as any major malformation of the heart or intrathoracic great vessels that is actually or potentially of functional significance. | Infants without cardiac malformation. | 36 / 426 | Completely overlapped with Thomas et al., 2021. |
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