| Study | Type of data | Exposure measurement | Outcome assessment | Adjustment |
|---|---|---|---|---|
| Adab (Carbamazepine), 2004 | retrospective cohort | A clinician conducted semi-structured interviews of mothers and clinical records were used to confirm information. | A semi-structured interview was used to collect data on additional educational needs. Dysmorphic features and major malformations were recorded by an examiner. A neuropsychologist used the Wechsler Intelligence Test for Children (6 to 16 yo) and the Schedule of Growing Skills II (birth to 5 yo). | None. |
| Adams (Carbamazepine), 2022 | retrospective cohort | Women were interviewed during the peri- and post- partum periods regarding multiple pregnancy characteristics and risks. | A blinded psychometrist who performed The Wechsler Intelligence Scale for Children, 3rd Edition (WISC-III) to measure general mental abilities in the context of a comprehensive neuropsychological testing battery. | Each antiseizure medication-exposed group was matched to an unexposed group of mothers according to educational and socioeconomic characteristics, and their children were then selected to match according to gender and age at testing. |
| Al Bunyan (Carbamazepine), 1999 | retrospective cohort | The antenatal and perinatal records of the pregnant epileptic patients were examined. | Records and the post-partum examinations were carried out by a paediatrician who documented any congenital anomalies present. | None. |
| Alsfouk (Carbamazepine), 2022 | retrospective cohort | Patients records. | Patients records. | None. |
| Alsfouk (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021 | retrospective cohort | Patients’ electronic and paper-based medical records. | Patients’ electronic and paper-based medical records. | None. |
| Alsfouk (Carbamazepine) (Controls unexposed, sick), 2021 | retrospective cohort | Patients’ electronic and paper-based medical records. | Patients’ electronic and paper-based medical records. | None. |
| AlSheikh (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020 | prospective cohort | Information was collected through a structured questionnaire ‘Questionnaire for Investigation of Epilepsy in Tropical Countries'. | Information was collected through a structured questionnaire ‘Questionnaire for Investigation of Epilepsy in Tropical Countries'. From the history, and through QuadraMed® hospital database (ICD-9 coding system). | None. |
| AlSheikh (Carbamazepine) (Controls unexposed, sick), 2020 | prospective cohort | Information was collected through a structured questionnaire ‘Questionnaire for Investigation of Epilepsy in Tropical Countries'. | Information was collected through a structured questionnaire ‘Questionnaire for Investigation of Epilepsy in Tropical Countries'. From the history, and through QuadraMed® hospital database (ICD-9 coding system). | None. |
| Arkilo (Carbamazepine), 2015 | retrospective cohort | Questionnaires were sent to women. | Questionnaires were sent to women. The developmental outcomes were assessed at 2 years of age by developmental specialists assigned by the school districts. | None. |
| Artama (Carbamazepine), 2005 | retrospective cohort (registry) | Information on the antiepileptic drugs received during pregnancy was abstracted from medical records of the mothers with epilepsy. | Information on pregnancy outcomes was abstracted from medical records of the mothers with epilepsy. Anomalies were classified according to the International Classification of Diseases, ninth revision (ICD-9). | Adjustment for maternal age at delivery or number of previous births did not affect the risk of congenital malformations in offspring related to different antiepileptic medications (results not shown). |
| Artama (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2013 | population based cohort retrospective | The Special Refund Entitlement Register and the Register on Reimbursement Drugs contained informations on maternal drug treatment under ATC category N03. | The Medical Birth Register data are collected from all maternity hospitals. Information on all deaths is revised and supplemented from the Cause-of-Death Register. Information on malformations are obtained from the Finnish Malformation Register. | No adjustment for this group of comparison. |
| Artama (Carbamazepine) (Controls unexposed, disease free), 2013 | population based cohort retrospective | The Special Refund Entitlement Register and the Register on Reimbursement Drugs contained informations on maternal drug treatment under ATC category N03. | The Medical Birth Register data are collected from all maternity hospitals. Information on all deaths is revised and supplemented from the Cause-of-Death Register. Information on malformations are obtained from the Finnish Malformation Register. | Adjusted for maternal age at delivery, parity, university hospital district, socioeconomic status and major congenital anomalies. |
| Artama (Carbamazepine) (Controls unexposed, sick), 2013 | population based cohort retrospective | The Special Refund Entitlement Register and the Register on Reimbursement Drugs contained informations on maternal drug treatment under ATC category N03. | The Medical Birth Register data are collected from all maternity hospitals. Information on all deaths is revised and supplemented from the Cause-of-Death Register. Information on malformations are obtained from the Finnish Malformation Register. | Adjusted for maternal age at delivery, parity, university hospital district, socioeconomic status and major congenital anomalies. |
| Arteaga-Vázquez (Carbamazepine), 2012 | case control | The intake of anticonvulsants was obtained by direct interview of the mother during the first 24 hours after delivery or by consulting the obstetric record. | Clinical examination systematized of all consecutive births that occur in the hospitals that participate in the program. Uniform information is obtained through the filling of a specifically designed clinical form for the registry. | None. |
| Aydin (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020 | retrospective cohort | Data were obtained from Perinatology Division’s computerized system. Antiepileptic drug use were reported. | Data were obtained from Perinatology Division’s computerized system. | None. |
| Aydin (Carbamazepine) (Controls unexposed, sick), 2020 | retrospective cohort | Data were obtained from Perinatology Division’s computerized system. Antiepileptic drug use were reported. | Data were obtained from Perinatology Division’s computerized system. | None. |
| Baker (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2015 | prospective cohort | An epilepsy specialist confirmed antiepileptic drugs. | The children IQ's were assessed by research assistants blinded to the exposure or maternal epilepsy status with the Differential Ability Scales. All neuropsychological assessments were double scored. Information was collected on educational intervention, defined as an educational need. | No adjustment for this group of comparison. |
| Baker (Carbamazepine) (Controls unexposed, disease free), 2015 | prospective cohort | An epilepsy specialist confirmed antiepileptic drugs. | The children IQ's were assessed by research assistants blinded to the exposure or maternal epilepsy status with the Differential Ability Scales. All neuropsychological assessments were double scored. Information was collected on educational intervention, defined as an educational need. | Significant confounders are socioeconomic status, maternal IQ, maternal age and gestational age of child at birth. |
| Baker (Carbamazepine) (Controls unexposed, sick), 2015 | prospective cohort | An epilepsy specialist confirmed antiepileptic drugs. | The children IQ's were assessed by research assistants blinded to the exposure or maternal epilepsy status with the Differential Ability Scales. All neuropsychological assessments were double scored. Information was collected on educational intervention, defined as an educational need. | No adjustment for this group of comparison. |
| Ban (Carbamazepine) (Mixed indications) (Controls exposed to Lamotrigine, sick), 2015 | prospective cohort | Relevant drug prescription in mothers’ primary care electronic health records from four weeks before conception to childbirth. | Diagnostic recordings of major congenital anomalies (excluding genetic anomalies and anomalies attributed to known teratogens) from the children’s general practice records. Classified these into system-specific groups based on EUROCAT classification. | No adjustment for this group of comparison. |
| Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015 | prospective cohort | Relevant drug prescription in mothers’ primary care electronic health records from four weeks before conception to childbirth. | Diagnostic recordings of major congenital anomalies (excluding genetic anomalies and anomalies attributed to known teratogens) from the children’s general practice records. Classified these into system-specific groups based on EUROCAT classification. | Adjusted for maternal age, year of childbirth, maternal body mass index, smoking and socioeconomic status. |
| Bànhidy (Carbamazepine), 2011 | case control | Mothers were mailed a questionnaire (after the selection of cases and controls) requested information on medicinal products taken during pregnancy and to send their prenatal maternity logbook and other medical records. Regional nurses were asked to visit and question the non-respondent. | Notification of cases with congenital abnormality is mandatory for physicians to the HCAR. Pathologists sent a copy of autopsy report for stillbirths and infant deaths cases and defect diagnosed in prenatal diagnostic centers with or without termination of pregnancy were also included. | Matched according to sex, birth week in the year when cases were born, and district of parents’ residence. |
| Bank (Carbamazepine) (Mixed indications), 2017 | prospective cohort | Medical records were obtained for review from the treating obstetrician, the delivery hospital, and the treating pediatrician. Umbilical cord and maternal venous blood were collected to measure total anti-epileptic levels by liquid chromatography/mass spectrometry. | Medical records were obtained for review from the treating obstetrician, the delivery hospital, and the treating pediatrician. | None. |
| Barqawi (Carbamazepine), 2005 | retrospective cohort | All patients were on treatment before pregnancy and the serum level of the drugs was taken at each visit. | Women were followed in the antenatal clinic from their initial visit through to delivery. The course of the pregnancy and the neonatal outcome were identified and compared between the groups. | None. |
| Barroso (Carbamazepine), 2015 | retrospective cohort | The complete medical records of both the mother and her newborn were later analyzed. | The complete medical records of both the mother and her newborn were later analyzed. To classify the congenital anomalies, they selected all cases independently if these alterations were malformations, disruptions or deformations. | None. |
| Battino (Carbamazepine), 1992 | prospective cohort | At least every 4 weeks throughout the pregnancy blood samples were taken for measurement of antiepileptic drugs concentrations. | Vital data of newborns at birth were recorded according to a standardized protocol; a more detailed clinical examination was performed on Day 5. | None. |
| Battino (Carbamazepine), 1999 | prospective cohort | Mothers were seen by an obstetrician and neurologist at least every 4 weeks throughout pregnancy, and blood samples were taken for the measurement of antiepileptic drugs concentrations. | The vital data of newborns at birth were recorded according to a standardized protocol; a more detailed clinical examination was performed on the fifth day. The infants were weighed within 1 hour of life, and their head circumference measured. | Adjustment for country, a family history of malformations, maternal age at delivery, parity, etiology or type of epilepsy, seizure frequency during pregnancy, the occurrence of neonatal malformations and treatment. |
| Bech (Carbamazepine) (Mixed indications), 2018 | population based cohort propective | The Danish National Prescription Register was used to obtain data on redeemed prescriptions using Anatomical Therapeutic Chemical (ATC) codes. | The Danish Psychiatric Central Register and Danish National Patient Registry were used to identify children's learning disabilities diagnosis using ICD-10 codes for: mental retardation (F7x), specific development disorders, ASD, emotional/behavioural disorders or having special educational needs. | Adjustments were made for maternal age at birth, educational level, smoking status, epilepsy, affective disorders, other psychiatric disorders, birth year, preterm birth, Apgar score and birth weight relative to gestational age. |
| Bjørk (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2018 | population based cohort propective | Information on anti-epileptics use was obtained from the questionnaires completed by mothers during gestational weeks 17 to 19 (Q1) and 30 (Q2); and through the Medical Birth Registry of Norway. | The instruments are based on parent-reported measures. Autistic traits were evaluated using the Modified Checklist for Autism (M-CHAT) at 18 months (missed any 3 of 23 items or 2 of 6 critical items) and Social Communication Questionnaire (SCQ) at 36 months (score of 13 or more). | No adjustment for this group of exposure. |
| Bjørk (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2022 | population based cohort retrospective | Prescriptions through national prescription registers according to Anatomical Therapeutic Chemical classification codes N03, N05BA09, and S01EC01. | Severe neurodevelopmental disorders are diagnosed by child psychiatrists and psychologists in specialist health care in the Nordic countries and recorded with International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes. | No adjustment for this control group. |
| Bjørk (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2022 | population based cohort retrospective | Prescriptions through national prescription registers according to Anatomical Therapeutic Chemical classification codes N03, N05BA09, and S01EC01. | Severe neurodevelopmental disorders are diagnosed by child psychiatrists and psychologists in specialist health care in the Nordic countries and recorded with International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes. | Adjusted for maternal age, education and marital status, parity, child’s birth year, sex, and country of birth. All the models were run with separate strata for country and year. Plus maternal use of antidepressants or opioids, depression, anxiety, personality disorders, number of chronic somatic diseases, and number of hospitalizations the year before last menstrual period. |
| Bjørk (Carbamazepine) (Controls unexposed, disease free), 2018 | population based cohort propective | Information on anti-epileptics use was obtained from the questionnaires completed by mothers during gestational weeks 17 to 19 (Q1) and 30 (Q2); and through the Medical Birth Registry of Norway. | The instruments are based on parent-reported measures. Autistic traits were evaluated using the Modified Checklist for Autism (M-CHAT) at 18 months (missed any 3 of 23 items or 2 of 6 critical items) and Social Communication Questionnaire (SCQ) at 36 months (score of 13 or more). | No adjustment for this group of exposure. |
| Bjørk (Carbamazepine) (Controls unexposed, sick), 2018 | population based cohort propective | Information on anti-epileptics use was obtained from the questionnaires completed by mothers during gestational weeks 17 to 19 (Q1) and 30 (Q2); and through the Medical Birth Registry of Norway. | The instruments are based on parent-reported measures. Autistic traits were evaluated using the Modified Checklist for Autism (M-CHAT) at 18 months (missed any 3 of 23 items or 2 of 6 critical items) and Social Communication Questionnaire (SCQ) at 36 months (score of 13 or more). | No adjustment for this group of exposure. |
| Bjørk (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2022 | population based cohort retrospective | Prescriptions through national prescription registers according to Anatomical Therapeutic Chemical classification codes N03, N05BA09, and S01EC01. | Severe neurodevelopmental disorders are diagnosed by child psychiatrists and psychologists in specialist health care in the Nordic countries and recorded with International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes. | No adjustment for this control group. |
| Blotière (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | retrospective cohort (claims database) | The French national health insurance database contains all health care claims reimbursed by French National Health Insurance. Include dispensed drugs coded according to the ATC classification. Monotherapy was defined as the absence of any other antiepileptic drug dispensed during the same period. | The French hospital discharge database (PMSI) provides detailes medical information including discharge diagnosis ICD-10 codes and medical procedures. Major congenital malformations (MCMs) were selected from the list of MCMs of the European Surveillance of Congenital Anomalies (EUROCAT) network. | No adjustment for this group of comparison. |
| Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 | retrospective cohort (claims database) | The French national health insurance database contains all health care claims reimbursed by French National Health Insurance. Include dispensed drugs coded according to the ATC classification. Monotherapy was defined as the absence of any other antiepileptic drug dispensed during the same period. | The French hospital discharge database (PMSI) provides detailes medical information including discharge diagnosis ICD-10 codes and medical procedures. Major congenital malformations (MCMs) were selected from the list of MCMs of the European Surveillance of Congenital Anomalies (EUROCAT) network. | For major congenital malformations with <5 cases per treatment group, authors calculated crude odds ratios with exact confidence intervals. For major congenital malformations with at least 5 cases per treatment group, ORs were adjusted for maternal age, mother’s eligibility for CMU-C, year of start of pregnancy, preconception folic acid supplementation, and pregestational diabetes. |
| Borthen (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2010 | population based cohort retrospective | A standardised antenatal form is filled in by doctors and transferred to the database by practitioners attending the delivery. Pregnancies registered with an anticonvulsant drug (according to ATC Classification System) were categorised as exposed. | A standardised antenatal form is filled in by doctors and transferred to the database by practitioners attending the delivery. It requests dichotomous data (yes/no) on both procedures and complications during labour and delivery with detailed information in free text. | No adjustment for this group of comparison. |
| Borthen (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2011 | retrospective cohort | Informations were extracted from a standardised antenatal form filled in by doctors and transferred to the database by practitioners attending the delivery and also from the neurological case records (according to ATC Classification System). | A standardised antenatal form is filled in by doctors and transferred to the database by practitioners attending the delivery. The hospital case records from all consultations, from labour and delivery and for the newborn were asked. | No adjustment and matching for this group of exposure. |
| Borthen (Carbamazepine) (Controls unexposed, disease free), 2010 | population based cohort retrospective | A standardised antenatal form is filled in by doctors and transferred to the database by practitioners attending the delivery. Pregnancies registered with an anticonvulsant drug (according to ATC Classification System) were categorised as exposed. | A standardised antenatal form is filled in by doctors and transferred to the database by practitioners attending the delivery. It requests dichotomous data (yes/no) on both procedures and complications during labour and delivery with detailed information in free text. | Adjusted for maternal age (years), < 20, 20–34, ≥ 35; maternal education (years), < 11, 11–14, ≥ 15; parity, 0, 1 ; smoking, no/yes; diabetes, no/yes (except for postpartum atony and haemorrhage, where diabetes is excluded). |
| Borthen (Carbamazepine) (Controls unexposed, disease free), 2011 | retrospective cohort | Informations were extracted from a standardised antenatal form filled in by doctors and transferred to the database by practitioners attending the delivery and also from the neurological case records (according to ATC Classification System). | A standardised antenatal form is filled in by doctors and transferred to the database by practitioners attending the delivery. The hospital case records from all consultations, from labour and delivery and for the newborn were asked. | Matched for age and parity. |
| Borthen (Carbamazepine) (Controls unexposed, sick), 2010 | population based cohort retrospective | A standardised antenatal form is filled in by doctors and transferred to the database by practitioners attending the delivery. Pregnancies registered with an anticonvulsant drug (according to ATC Classification System) were categorised as exposed. | A standardised antenatal form is filled in by doctors and transferred to the database by practitioners attending the delivery. It requests dichotomous data (yes/no) on both procedures and complications during labour and delivery with detailed information in free text. | No adjustment for this group of comparison. |
| Borthen (Carbamazepine) (Controls unexposed, sick), 2011 | retrospective cohort | Informations were extracted from a standardised antenatal form filled in by doctors and transferred to the database by practitioners attending the delivery and also from the neurological case records (according to ATC Classification System). | A standardised antenatal form is filled in by doctors and transferred to the database by practitioners attending the delivery. The hospital case records from all consultations, from labour and delivery and for the newborn were asked. | No adjustment and matching for this group of exposure. |
| Bromley (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2010 | prospective cohort | The research nurse took a personal and medical history in accordance with the prospectively designed Patient Basic and Control Basic Record Forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records. | Each child was assessed by an assistant psychologist blinded using the Griffiths Mental Development Scales in either their local hospital or their home. Feedback on the child’s development was provided to the families, and, where necessary, referrals to specialist services were made. | No matching for this group of exposure. No adjustment. |
| Bromley (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2013 | prospective cohort | Information was recorded from maternal interview and checked against medical records. An epilepsy specialist confirmed antiepileptic durg type and dose. | Information was collected on confirmed diagnosis of ASD, ADHD and dyspraxia. Indication that a child had seen a specialist was documented and followed up with the diagnosing health professional, family doctor or school nurse. The researchers played no clinical role in the diagnosis of the child. | No adjustment for this group of comparison. |
| Bromley (Carbamazepine) (Controls unexposed, disease free), 2010 | prospective cohort | The research nurse took a personal and medical history in accordance with the prospectively designed Patient Basic and Control Basic Record Forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records. | Each child was assessed by an assistant psychologist blinded using the Griffiths Mental Development Scales in either their local hospital or their home. Feedback on the child’s development was provided to the families, and, where necessary, referrals to specialist services were made. | Matched for age, within a 5-year band, and for parity. No adjustment. |
| Bromley (Carbamazepine) (Controls unexposed, disease free), 2013 | prospective cohort | Information was recorded from maternal interview and checked against medical records. An epilepsy specialist confirmed antiepileptic durg type and dose. | Information was collected on confirmed diagnosis of ASD, ADHD and dyspraxia. Indication that a child had seen a specialist was documented and followed up with the diagnosing health professional, family doctor or school nurse. The researchers played no clinical role in the diagnosis of the child. | Candidate variables were seizures during pregnancy, maternal IQ, maternal age, socio-economic status, alcohol or nicotine exposure, gender and gestational age at birth. But the variables kept in the final regression model are not specified (data not shown). |
| Bromley (Carbamazepine) (Controls unexposed, sick), 2010 | prospective cohort | The research nurse took a personal and medical history in accordance with the prospectively designed Patient Basic and Control Basic Record Forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records. | Each child was assessed by an assistant psychologist blinded using the Griffiths Mental Development Scales in either their local hospital or their home. Feedback on the child’s development was provided to the families, and, where necessary, referrals to specialist services were made. | No matching for this group of exposure. No adjustment. |
| Bromley (Carbamazepine) (Controls unexposed, sick), 2013 | prospective cohort | Information was recorded from maternal interview and checked against medical records. An epilepsy specialist confirmed antiepileptic durg type and dose. | Information was collected on confirmed diagnosis of ASD, ADHD and dyspraxia. Indication that a child had seen a specialist was documented and followed up with the diagnosing health professional, family doctor or school nurse. The researchers played no clinical role in the diagnosis of the child. | No adjustment for this group of comparison. |
| Bromley (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023 | prospective cohort | The prescribed dose of the antiseizure medications was recorded prospectively from both medical records and maternal interviews at recruitment, and then again at ≥32 weeks gestation (by telephone interviews). | Birth or fetal outcome, including information on congenital anomalies, was taken from hospital records. At 24 months (=/ 6 months) the Bayley Scales of Infant and Toddler Development was completed at home, with the child by 2 senior blinded assessors. | Multiple regression model results not extractable. Women were excluded if they had a significant level of learning disability (e.g., unable to live independently), had another acute or chronic health condition for which they were taking a concomitant medication (non- ASM) with a known teratogenic profile (e.g., isotretinoin, warfarin, mycophenolate). |
| Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 | prospective cohort | The prescribed dose of the antiseizure medications was recorded prospectively from both medical records and maternal interviews at recruitment, and then again at ≥32 weeks gestation (by telephone interviews). | Birth or fetal outcome, including information on congenital anomalies, was taken from hospital records. At 24 months (=/ 6 months) the Bayley Scales of Infant and Toddler Development was completed at home, with the child by 2 senior blinded assessors. | Multiple regression model results not extractable. Women were excluded if they had a significant level of learning disability (e.g., unable to live independently), had another acute or chronic health condition for which they were taking a concomitant medication (non- ASM) with a known teratogenic profile (e.g., isotretinoin, warfarin, mycophenolate). |
| Burja (Carbamazepine) (Controls unexposed, disease free), 2006 | retrospective cohort (registry) | Hospital neonatal and obstetric records at the MariborTeaching Hospital Department of Perinatology. | Data on the main outcome measures were recorded by health practitioners and extracted from the Regional Hospital Discharge Registry. The data are transferred from the registry to the Perinatal Statistical Database of Slovenia. Diagnoses were classified according to ICD10. | None. |
| Burja (Carbamazepine) (Controls unexposed, sick), 2006 | retrospective cohort (registry) | Hospital neonatal and obstetric records at the MariborTeaching Hospital Department of Perinatology. | Data on the main outcome measures were recorded by health practitioners and extracted from the Regional Hospital Discharge Registry. The data are transferred from the registry to the Perinatal Statistical Database of Slovenia. Diagnoses were classified according to ICD10. | None. |
| Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014 | prospective cohort | Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified. | Outcome data were collected by sending the patient’s general practitioner a standardised questionnaire for completion during the follow-up duration. Other health care practitioners were contacted if identified. | None. |
| Campbell (Carbamazepine) (Controls unexposed, sick), 2014 | prospective cohort | Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified. | Outcome data were collected by sending the patient’s general practitioner a standardised questionnaire for completion during the follow-up duration. Other health care practitioners were contacted if identified. | None. |
| Canger (Carbamazepine), 1999 | prospective cohort | The patients received monthly obstetric and neurologic examinations, and antiepileptic drug blood levels were tested monthly. | At the time of delivery the infants underwent a standardized examination by a pediatrician, and a more detailed clinical examination on day 5 in San Paolo Hospital only and during the first months in other hospitals (if so medical records were also acquired). | None. |
| Cassina (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2013 | prospective cohort | At the first contact with the service, pregnant women answered to a formulated questionnaire. In addition, details regarding the treatment with antiepileptic drugs taken after the first contact to the Teratology Information Service were ascertained by a follow-up telephone interview. | Women or their physicians were contacted for a follow-up telephone interview to collect information about major birth defects. The data collected by interview are reliable, since all the Italian children have to undergo periodic pediatric evaluations. | No adjustment for this group of comparison. |
| Cassina (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2013 | prospective cohort | At the first contact with the service, pregnant women answered to a formulated questionnaire. In addition, details regarding the treatment with antiepileptic drugs taken after the first contact to the Teratology Information Service were ascertained by a follow-up telephone interview. | Women or their physicians were contacted for a follow-up telephone interview to collect information about major birth defects. The data collected by interview are reliable, since all the Italian children have to undergo periodic pediatric evaluations. | No adjustment for this group of exposure. |
| Charlton (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2011 | retrospective cohort (claims database) | Data generated during routine clinical practice in the UK General Practice Research Database (GPRD). All prescriptions issued by general practitioners are recorded in the database. | Children who had ≥ 1 medical codes relating to any type of congenital malformation using a list based on ICD-9 codes were identified in the UK General Practice Research Database. All codes identified were verified by supporting evidence in the form of free text or photocopied records. | Not specified. |
| Charlton (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2017 | retrospective cohort (claims database) | Determined from issued prescription records. The UK Clinical Practice Research Datalink contains anonymised, patient medical and prescribing records routinely collected within general practice. | All children in the study population with a diagnosis recorded were identified based on Read codes in their electronic record. The neurodevelopmental disorders identified were verified by the authors by supporting evidence in the form of free text or photocopied records. | No matching and adjustment for this group of comparison. |
| Charlton (Carbamazepine) (Controls unexposed, disease free), 2017 | retrospective cohort (claims database) | Determined from issued prescription records. The UK Clinical Practice Research Datalink contains anonymised, patient medical and prescribing records routinely collected within general practice. | All children in the study population with a diagnosis recorded were identified based on Read codes in their electronic record. The neurodevelopmental disorders identified were verified by the authors by supporting evidence in the form of free text or photocopied records. | Matching on maternal age at pregnancy start, year of delivery, sex of the child and GP practice/socioeconomic status of general practitioner practice and adjusts for alcohol drinking status. |
| Charlton (Carbamazepine) (Controls unexposed, sick), 2011 | retrospective cohort (claims database) | Data generated during routine clinical practice in the UK General Practice Research Database (GPRD). All prescriptions issued by general practitioners are recorded in the database. | Children who had ≥ 1 medical codes relating to any type of congenital malformation using a list based on ICD-9 codes were identified in the UK General Practice Research Database. All codes identified were verified by supporting evidence in the form of free text or photocopied records. | Not specified. |
| Charlton (Carbamazepine) (Controls unexposed, sick), 2017 | retrospective cohort (claims database) | Determined from issued prescription records. The UK Clinical Practice Research Datalink contains anonymised, patient medical and prescribing records routinely collected within general practice. | All children in the study population with a diagnosis recorded were identified based on Read codes in their electronic record. The neurodevelopmental disorders identified were verified by the authors by supporting evidence in the form of free text or photocopied records. | No matching and adjustment for this group of comparison. |
| Christensen (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013 | population based cohort propective | The Danish Prescription Register holds information on prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes. | The Danish Psychiatric Central Register was used to identify children's diagnosis : ICD-10 codes F84.0, F84.1, F84.5, F84.8, and F84.9 for autism spectrum disorder and F84.0 for childhood autism. And also the National Hospital Register to identify children diagnosed with congenital malformations. | No adjustment for this group of comparison. |
| Christensen (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2015 | population based cohort propective | The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes. | The Danish Medical Birth Registry contains data on newborn children including information on gestational age and Apgar score (0–10) at birth (5 min). | Results adjusted for maternal age (divided into tertiles) and smoking (yes, no). But when analysing individual drugs, there were too few exposed cases to allow for adjusted estimates. |
| Christensen (Carbamazepine) (Controls unexposed NOS) (Indications NOS), 2013 | population based cohort propective | The Danish Prescription Register holds information on prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes. | The Danish Psychiatric Central Register was used to identify children's diagnosis : ICD-10 codes F84.0, F84.1, F84.5, F84.8, and F84.9 for autism spectrum disorder and F84.0 for childhood autism. And also the National Hospital Register to identify children diagnosed with congenital malformations. | Adjusted for risk factors for autism (parental age at conception, parental psychiatric history, gestational age, birth weight, sex of the child, congenital malformations, and parity). |
| Christensen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2015 | population based cohort propective | The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes. | The Danish Medical Birth Registry contains data on newborn children including information on gestational age and Apgar score (0–10) at birth (5 min). | Results adjusted for maternal age (divided into tertiles) and smoking (yes, no). But when analysing individual drugs, there were too few exposed cases to allow for adjusted estimates. |
| Christensen (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2015 | population based cohort propective | The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes. | The Danish Medical Birth Registry contains data on newborn children including information on gestational age and Apgar score (0–10) at birth (5 min). | No adjustment for this group of comparison. |
| Cohen (Carbamazepine), 2011 | prospective cohort | They obtained information from the patients, their seizure or medication diary, or review of their medical records. | Blinded assessors used the Motor Scale from the Bayley Scales of Infant Development - II. The child’s parents and preschool teacher/daycare worker complete the Adaptive Behavior Assessment System - II and the Behavior Assessment System for Children. Parents complete the Parent Stress Index - III. | Adjusted for maternal IQ, standardized dose, gestational age at birth, and site location (US/UK) for the Bayley Scales of Infant Development - II and adjusted for standardized dose and maternal education beyond high school (yes/no) for the Adaptive Behavior Assessment System - II. |
| Cohen (Carbamazepine), 2013 | prospective cohort | They obtained information from the patients, their seizure or medication diary, or review of their medical records. | The child’s parents and teacher complete the Adaptive Behavior Assessment System Second Edition (ABAS-II), to complete the Behavior Assessment System for Children (BASC) and the Parent Stress Index Third Edition (PSI-III). Each rating scale was scored by assessors blinded to the AED used. | Mean adjusted for maternal IQ, standardized AED dose, birth gestational age, and preconception folate use. |
| Cohen (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | retrospective cohort (claims database) | The Medicaid Analytic Extract data include prescriptions filled on an outpatient basis. | Claims in maternal or infant records after 20 weeks of gestation and were validated based on medical record review. The outcomes are assessed with ICD-9 diagnosis. | Adjustment for demographic factors and risk factors for ischemic placental disease and preterm birth, potential indication for mood stabilizer use, other psychiatric and pain diagnoses, other psychiatric and pain medications (LMP-90 to LMP 140), and severity/health service utilization proxies. |
| Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 | retrospective cohort (claims database) | The Medicaid Analytic Extract data include prescriptions filled on an outpatient basis. | Claims in maternal or infant records after 20 weeks of gestation and were validated based on medical record review. The outcomes are assessed with ICD-9 diagnosis. | Adjustment for demographic factors and risk factors for ischemic placental disease and preterm birth, potential indication for mood stabilizer use, other psychiatric and pain diagnoses, other psychiatric and pain medications (LMP-90 to LMP 140), and severity/health service utilization proxies. |
| Cohen (Carbamazepine) (Mixed indications) (Controls exposed to LTG), 2023 | population based cohort retrospective | Data on filled prescriptions were obtained from the medical birth registers linked with registers for prescribed drugs. | The primary outcome was major congenital malformation diagnosed within 1 year of birth and recorded in the medical birth, patient, malformation, or death register. | Adjusted for maternal age, delivery year, country, parity, multiple pregnancy, cohabitation, maternal country of birth, indications for antiseizure medication, diabetes, hypertension, psychiatric conditions, other medication used in 1st trimester and indicators of health care utilization in the 90 days before pregnancy. Exclusion of first trimester exposure to known teratogenic drugs or infection. |
| Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023 | population based cohort retrospective | Data on filled prescriptions were obtained from the medical birth registers linked with registers for prescribed drugs. | The primary outcome was major congenital malformation diagnosed within 1 year of birth and recorded in the medical birth, patient, malformation, or death register. | Adjusted for maternal age, delivery year, country, parity, multiple pregnancy, cohabitation, maternal country of birth, indications for antiseizure medication, diabetes, hypertension, psychiatric conditions, other medication used in 1st trimester and indicators of health care utilization in the 90 days before pregnancy. Exclusion of first trimester exposure to known teratogenic drugs or infection. |
| Coste (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 | retrospective cohort (claims database) | Defned by at least one dispensing of the drug to the mother between the beginning of the month preceding onset of pregnancy and the end of pregnancy. Mother had used this drug as monotherapy, defined by the use of a single drug during pregnancy. | Diagnoses of mental and behavioural disorders by the attribution of long-term disease status and/or hospital admission (ICD-10 codes). Health care utilization by reimbursement of at least one speech therapy session; one orthoptist consultation; one psychiatrist or child psychiatrist consultation. | Sociodemographic, folic acid, SSRI during pregnancy, antipsychotic drug use during the year preceding pregnancy, a proxy for severity of mental disorders, history of mental and behavioural disorders not related to alcohol or smoking, indicator of tobacco use and alcohol use, child’s sex, gestational age and birth weight. |
| Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 | retrospective cohort (claims database) | Defned by at least one dispensing of the drug to the mother between the beginning of the month preceding onset of pregnancy and the end of pregnancy. Mother had used this drug as monotherapy, defined by the use of a single drug during pregnancy. | Diagnoses of mental and behavioural disorders by the attribution of long-term disease status and/or hospital admission (ICD-10 codes). Health care utilization by reimbursement of at least one speech therapy session; one orthoptist consultation; one psychiatrist or child psychiatrist consultation. | Adjusted for: mother’s age, Complementary Universal Health Insurance scheme, diagnosis of mental illness other than tobacco and alcohol use disorders, antipsychotic drug use during the year preceding pregnancy, indicator of severity of psychiatric morbidity, indicator of tobacco use, indicator of alcohol use, folic acid, SSRI during pregnancy, child’s sex, gestational age and birth weight. |
| Cummings (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2011 | retrospective cohort (registry) | Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. | Children were evaluated by a single researcher blinded to exposure, assessment consisted of a physical and neurodevelopmental examination using The Bayley Scales of Infant Development (42 months and younger) and the Griffiths Scale of Infant Development (older than 42 months). | No adjustment for this group of comparison. |
| Cummings (Carbamazepine) (Controls unexposed, disease free), 2011 | retrospective cohort (registry) | Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. | Children were evaluated by a single researcher blinded to exposure, assessment consisted of a physical and neurodevelopmental examination using The Bayley Scales of Infant Development (42 months and younger) and the Griffiths Scale of Infant Development (older than 42 months). | The only confounding variables which persisted as significant adverse factors, were age, gender and socioeconomic status. |
| Czeizel (Carbamazepine) (Mixed indications), 1992 | case control | Mothers were mailed a questionnaire requested information on medicinal products taken during pregnancy and to send their prenatal maternity logbook which related drug prescriptions. Regional nurses were asked to visit and question the non-respondent. | Notification of cases with congenital abnormality is mandatory for physicians to the HCAR. Pathologists sent autopsy report for stillbirths and infant deaths cases. Prenatally diagnosed and electively terminated malformed fetuses have also been registered. | None. |
| D'Souza (Carbamazepine) (Controls unexposed, disease free), 1991 | prospective cohort | Every two weeks, clinical assessment of seizure control, and adjustment of anticonvulsant dosage in accordance with serum drug concentration or clinical response. | Each infant was examined by a paediatrician and a geneticist, neither of whom was aware of whether the mother was in the study group or the control group. | Matched for maternal age, parity, and social class. |
| D'Souza (Carbamazepine) (Controls unexposed, sick), 1991 | prospective cohort | Every two weeks, clinical assessment of seizure control, and adjustment of anticonvulsant dosage in accordance with serum drug concentration or clinical response. | Each infant was examined by a paediatrician and a geneticist, neither of whom was aware of whether the mother was in the study group or the control group. | No matching for this group of exposure. |
| Dean (Carbamazepine), 2002 | retrospective cohort | A structured interview was carried out by a trained research nurse using questionnaires. | Standardised assessment was carried out by a trained research nurse using examination schedules. Clinical photographs were assessed for facial features. Behavior disorders, developmental delay and later childhood medical problems were recorded and/or diagnosed by specialists. | None. |
| Dean (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2007 | retrospective cohort | A trained research nurse undertook interviews recording antiepileptic drugs use in each pregnancy. Maternal antiepileptic drugs dose was verified from case records where possible. | A trained research nurse undertook interviews recording children’s medical and developmental histories. Malformations and medical histories for the children were confirmed by hospital record review and clinical examination. Facial photographs were reviewed for features of FACS by blinded physicians | None. |
| Dean (Carbamazepine) (Controls unexposed, sick), 2007 | retrospective cohort | A trained research nurse undertook interviews recording antiepileptic drugs use in each pregnancy. Maternal antiepileptic drugs dose was verified from case records where possible. | A trained research nurse undertook interviews recording children’s medical and developmental histories. Malformations and medical histories for the children were confirmed by hospital record review and clinical examination. Facial photographs were reviewed for features of FACS by blinded physicians | None. |
| Deshmukh (Carbamazepine), 2016 | prospective cohort | Women were questioned with a computer-assisted telephone interview 3 times. | Data on each enrolled child’s development were then collected from mothers by telephone, using the Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Survey Interview Form and were conducted by non-blinded research coordinators. Interviews were then scored. | Adjusted for propensity scores from maternal age, maternal education, folate use, cigarette and alcohol exposure, gestational age, and gestational weight. |
| Diav-Citrin (Carbamazepine), 2001 | prospective cohort | Details of exposure were collected during pregnancy at the initial contact before pregnancy outcome was known, using a structured questionnaire. | After the expected date of delivery, follow-up was conducted with the woman or her physicians via a telephone interview according to a structured questionnaire. The treating physician was reached to verify cases of malformation if possible. | Matched by the year and the gestational and maternal age at time of call. No adjustment. |
| Díaz-Romero (Carbamazepine), 1999 | cohort | Not specified | The neonates were evaluated by the principal author who used a metallic calliper calibrated in millimeters and a glazed fiberglass tape for the head circumference. The measurements were performed twice and collected by a second observer; the final value was the average of both measurements. | None. |
| Dreier (Carbamazepine), 2021 | population based cohort retrospective | Reimbursement codes for prescriptions. | Hospital-based diagnoses and medical birth registries. | Adjustment for materal characteristics (no more on this subject). |
| Dreier (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023 | population based cohort propective | Information on use of antiseizure medications was based on the national prescription registers, which contain information on all reimbursed prescription medications dispensed at pharmacies in each country, including date of dispensing and Anatomical Therapeutic Chemical (ATC) classification code. | Information on psychiatric disorders was retrieved from the patient registers, which contain diagnostic information from inpatient admissions and outpatient visits in specialist care. | Singletons only. No adjustment for this group of comparison. |
| Dreier (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 | population based cohort propective | Information on use of antiseizure medications was based on the national prescription registers, which contain information on all reimbursed prescription medications dispensed at pharmacies in each country, including date of dispensing and Anatomical Therapeutic Chemical (ATC) classification code. | Information on psychiatric disorders was retrieved from the patient registers, which contain diagnostic information from inpatient admissions and outpatient visits in specialist care. | Singletons only. Adjusted for year of birth, country of birth, sex of the child, smoking in pregnancy, use of antidepressants (ATC code N06A) in pregnancy, and maternal characteristics assessed at the time of birth (age, parity, highest level of completed education, and psychiatric co-morbidity). |
| Endo (Carbamazepine) (Controls unexposed, disease free), 2004 | retrospective cohort | Medical records. | Medical records. | Not specified. |
| Endo (Carbamazepine) (Controls unexposed, sick), 2004 | retrospective cohort | Medical records. | Medical records. | Not specified. |
| Eriksson (Carbamazepine), 2005 | prospective cohort | The medical records of the children and their mothers were reviewed separately by two of the other authors. | All children were examined by the pediatric neurologist and a neuropsychologist, cognitive, neuropsychological and neurological functioning of the children was assessed using Touwens test, the Wechsler Intelligence Scale for Children WISC-III and the Developmental Neuropsychological Assessment. | No age and gender-matched children for this group of exposure. |
| Forsberg (Carbamazepine) (Controls unexposed NOS), 2011 | retrospective cohort (registry) | The Medical Birth Register is built from data in standardized medical records. To identify the use of anticonvulsants, the original medical documents were retrieved and scrutinized and the information was added to the records of deliveries from women with epilepsy. | The Swedish School Mark Registry was used to obtain information about school grades from the last year of compulsory school, at age 16. School grades in four subjects were further analyzed: sports, and the three core subjects, mathematics, English, and Swedish. | Not specified. |
| Forsberg (Carbamazepine) (Controls unexposed, sick), 2011 | retrospective cohort (registry) | The Medical Birth Register is built from data in standardized medical records. To identify the use of anticonvulsants, the original medical documents were retrieved and scrutinized and the information was added to the records of deliveries from women with epilepsy. | The Swedish School Mark Registry was used to obtain information about school grades from the last year of compulsory school, at age 16. School grades in four subjects were further analyzed: sports, and the three core subjects, mathematics, English, and Swedish. | Not specified. |
| Gaily (Carbamazepine) (Controls unexposed, disease free), 2004 | prospective cohort | Data have been collected prospectively and entered to a database maintained by one of the authors. | Neuropsychologists were blinded and executed neuropsychological examination on children. They used six subtests of Wechsler Preschool and Primary Scale of Intelligence–Revised or Wechsler Intelligence Scale for Children–Revised. Sometimes, only tests done before the present study were available. | None. |
| Gaily (Carbamazepine) (Controls unexposed, sick), 2004 | prospective cohort | Data have been collected prospectively and entered to a database maintained by one of the authors. | Neuropsychologists were blinded and executed neuropsychological examination on children. They used six subtests of Wechsler Preschool and Primary Scale of Intelligence–Revised or Wechsler Intelligence Scale for Children–Revised. Sometimes, only tests done before the present study were available. | None. |
| Hernández-Díaz (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2012 | prospective cohort | Women were questioned with a computer-assisted telephone interview 3 times. | Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist. | No adjustment for this group of comparison. |
| Hernández-Díaz (Carbamazepine) (Controls unexposed, disease free), 2012 | prospective cohort | Women were questioned with a computer-assisted telephone interview 3 times. | Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist. | Neither restriction to pure prospective enrollees, nor adjustment for potential confounders, nor restriction to women with epilepsy, nor use of AED information from medical records (data not shown) changed the results significantly. |
| Holmes (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2011 | prospective cohort | Women were questioned with a computer-assisted telephone interview 3 times. | Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist. | None. |
| Holmes (Carbamazepine) (Controls unexposed, disease free), 2001 | retrospective cohort | Women are interviewed and completed questionnaires administered by a research assistant. | The infants were examined by a study physician or the results of the pediatrician’s examination were reviewed if a mother chose not to enroll. For major malformations: features found on prenatal ultrasonography but not on physical examination were excluded. | For cigarette and alcohol use, substance abuse, severity of seizures, and head circumference and height of the mother. |
| Holmes (Carbamazepine) (Controls unexposed, disease free), 2011 | prospective cohort | Women were questioned with a computer-assisted telephone interview 3 times. | Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist. | None. |
| Holmes (Carbamazepine) (Controls unexposed, sick), 2001 | retrospective cohort | Women are interviewed and completed questionnaires administered by a research assistant. | The infants were examined by a study physician or the results of the pediatrician’s examination were reviewed if a mother chose not to enroll. For major malformations: features found on prenatal ultrasonography but not on physical examination were excluded. | No adjustment for this group of comparison. |
| Hosny (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021 | prospective cohort | The following data were evaluated: seizure control 6 months before pregnancy, seizure control during each trimester, type and dose of ASMs at conception. | Result of high-resolution ultra-sonography in the 14th to 16th gestational weeks was recorded. | No adjustment. |
| Hosny (Carbamazepine) (Controls unexposed, sick), 2021 | prospective cohort | The following data were evaluated: seizure control 6 months before pregnancy, seizure control during each trimester, type and dose of ASMs at conception. | Result of high-resolution ultra-sonography in the 14th to 16th gestational weeks was recorded. | No adjustment. |
| Huber-Mollema (Carbamazepine), 2019 | prospective cohort | The data concerning treatment at the time of conception are obtained by the physicians responsible for the women’s care and transferred online. | Mother and father completed the Child Behavior Checklist and the Social Emotional Questionnaire online. Parents completed an online questionnaire on demographic information, development, and child needs. | No adjustment for this comparison group. |
| Husebye (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020 | population based cohort propective | Information on the anti-epileptic (AED) use was obtained from the maternal questionnaires completed during gesta week 17–19 and week 30 and from Medical Birth Registry data. AEDs plasma concentrations were analysed in maternal and umbilical cord samples (73%) and were detected in 93% of children. | Parent-reported screening instruments: the Ages and Stages Questionnaires (at 5 years) the Speech and Language Assessment Scale (at 5 years) and the Norwegian instrument Twenty Statements about Language-related Difficulties (at 5 and 8 years). | No adjustment for this group of comparison. |
| Husebye (Carbamazepine) (Controls unexposed, disease free), 2020 | population based cohort propective | Information on the anti-epileptic (AED) use was obtained from the maternal questionnaires completed during gesta week 17–19 and week 30 and from Medical Birth Registry data. AEDs plasma concentrations were analysed in maternal and umbilical cord samples (73%) and were detected in 93% of children. | Parent-reported screening instruments: the Ages and Stages Questionnaires (at 5 years) the Speech and Language Assessment Scale (at 5 years) and the Norwegian instrument Twenty Statements about Language-related Difficulties (at 5 and 8 years). | Maternal age, parental SES, low household income, parity, maternal prepregnancy BMI, maternal report of familial language delay (5y model), smoking and alcohol (8y model), maternal anxiety/depression, Apgar score at 5 min, gestational age, report of seldom/never helping child read letters and sounds during a typical week (5y model) or report of never reading to their child (8y model). |
| Husebye (Carbamazepine) (Controls unexposed, sick), 2020 | population based cohort propective | Information on the anti-epileptic (AED) use was obtained from the maternal questionnaires completed during gesta week 17–19 and week 30 and from Medical Birth Registry data. AEDs plasma concentrations were analysed in maternal and umbilical cord samples (73%) and were detected in 93% of children. | Parent-reported screening instruments: the Ages and Stages Questionnaires (at 5 years), the Speech and Language Assessment Scale (at 5 years) and the Norwegian instrument Twenty Statements about Language-related Difficulties (at 5 and 8 years). | No adjustment for this group of comparison. |
| Hvas (Carbamazepine) (Controls unexposed, disease free), 2000 | retrospective cohort | Women completed a questionnaire. They were categorised as users or nonusers of anticonvulsant drugs, by self-reported daily intake of any anticonvulsant drug during the first trimester. | Women completed a questionnaire. Information about major congenital malformations was also collected. | No adjustment for this group of exposure. |
| Hvas (Carbamazepine) (Controls unexposed, sick), 2000 | retrospective cohort | Women completed a questionnaire. They were categorised as users or nonusers of anticonvulsant drugs, by self-reported daily intake of any anticonvulsant drug during the first trimester. | Women completed a questionnaire. Information about major congenital malformations was also collected. | No adjustment for this group of exposure. |
| Jentink (Carbamazepine), 2010 | case control | The EUROCAT central database contains medications taken in the first trimester of pregnancy (Anatomical Therapeutic Chemical coded). | EUROCAT major congenital malformation classification (based on ICD-10). | Adjusted for maternal age (categorised into <25, 25-29, 30-34, and >34 years) and year of birth of the child (categorised as before 1999, 1999-2001, and 2002 onwards). If there were sufficient numbers of cases the adjusted odds ratio was also corrected for the reporting registry. |
| Kaaja (Carbamazepine), 2003 | prospective cohort | Follow-up of the pregnant women with epilepsy included assessment of serum concentration of antiepileptic drugs at the end of the first trimester. | Infants were examined by a neonatologist at birth and at discharge from the hospital and charts for the infants admitted to the pediatric clinic or in case of termination of pregnancy were reviewed. Autopsy was performed on stillbirth. | No adjustment for this group of exposure. |
| Källén (Carbamazepine), 1994 | nested case control | Information on epilepsy during pregnancy and possible anticonvulsant drugs used were obtained from the Maternal Health Centre records (usually weeks 10 to 12 of pregnancy). | Diagnoses in the Medical Birth Registry. Authors retrieved the original hospital records. | Matched for year of birth, maternal age (5 year class), and parity (1, 2, 3, 4 ). |
| Källén (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013 | population based cohort retrospective | At the midwife interview at the first antenatal care visit, the woman was asked if she had used any drugs since she became pregnant. Or determined by the use of the Swedish Register of Prescribed Drugs (since 2006). | The Swedish Medical Birth Registry contain information based on standardized medical records from the first and further antenatal visit, the delivery and the paediatric examination. Supplemented with data from the Register of Birth Defects and Hospital Discharge Register. | No adjustment for this group of comparison. |
| Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013 | population based cohort retrospective | At the midwife interview at the first antenatal care visit, the woman was asked if she had used any drugs since she became pregnant. Or determined by the use of the Swedish Register of Prescribed Drugs (since 2006). | The Swedish Medical Birth Registry contain information based on standardized medical records from the first and further antenatal visit, the delivery and the paediatric examination. Supplemented with data from the Register of Birth Defects and Hospital Discharge Register. | Adjustment was made for year of birth, maternal age (5-year class), parity, smoking in early pregnancy and BMI. |
| Kaneko (Carbamazepine), 1999 | prospective cohort | Mothers were seen by an obstetrician and neurologist at least every 4 weeks throughout pregnancy, and blood samples were taken for the measurement of antiepileptic drugs concentrations. | Congenital malformations were examined at each center at birth, at 5 days, and at the 1-month visit by a team of obstetricians and neurologists, according to a standardized check-list based on the report of the Japanese Association of Obstetricians for Maternal Welfare. | None. |
| Kasradze (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2017 | prospective cohort | Antiepileptic drugs and total daily dosage before pregnancy/at 1st trimester/at 2nd trimester/at 3rd trimester were assessed retrospectively during the mother's structured interview. | Two forms of Wechsler Preschool and Primary Scale of Intelligence (WPPSI-4) were used to assess intellectual functioning for children aged 2.6–3.1 years and for children aged 4.0–7.7 years. All tests were performed in the Epilepsy Centre by two qualified blinded neuropsychologists. | No matching for this group of comparison. |
| Kasradze (Carbamazepine) (Controls unexposed, disease free), 2017 | prospective cohort | Antiepileptic drugs and total daily dosage before pregnancy/at 1st trimester/at 2nd trimester/at 3rd trimester were assessed retrospectively during the mother's structured interview. | Two forms of Wechsler Preschool and Primary Scale of Intelligence (WPPSI-4) were used to assess intellectual functioning for children aged 2.6–3.1 years and for children aged 4.0–7.7 years. All tests were performed in the Epilepsy Centre by two qualified blinded neuropsychologists. | Age and gender-matched. |
| Katz (Carbamazepine), 2001 | retrospective cohort | Telephone interviews were given to the patient as a supplement to the chart analysis. Spouses were interviewed only when additional information could not be provided by the patient. | Data collected in chart review about the newborn included the presence of developmental delay. Including pervasive developmental delay (based on the DSM-IV-TR criteria), combined or isolated speech and gross motor delay and attention deficit disorder with speech and auditory processing delay. | None. |
| Kilic (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 | population based cohort retrospective | The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes. | The Danish Medical Birth Registry contains data on newborn babies including information on gestational age at birth, birth weight, and head circumference. | No adjustment for this group of comparison. |
| Kilic (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2014 | population based cohort retrospective | The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes. | The Danish Medical Birth Registry contains data on newborn babies including information on gestational age at birth, birth weight, and head circumference. | Adjusted for potential confounding factors, including maternal age, smoking, substance abuse, cohabitation, income, education, and parity. |
| Kilic (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 | population based cohort retrospective | The Danish Register of Medicinal Product Statistics holds information on all redeemed prescriptions. Monotherapy exposure was defined as redemption of prescription for one type of AED with the Anatomical Therapeutic Codes. | The Danish Medical Birth Registry contains data on newborn babies including information on gestational age at birth, birth weight, and head circumference. | No adjustment for this group of comparison. |
| Kini (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2006 | retrospective cohort | Structured interviews were conducted with the mothers and medical records were available to confirm details in about 80% of participants. | A clinical examination was carried out to check the growth parameters and detect dysmorphic features and malformations. Clinical photographs were reviewed based on whether the gestalt was suggestive of fetal anticonvulsant syndrome by a panel of blind dysmorphologists. | None. |
| Kini (Carbamazepine) (Controls unexposed, sick), 2006 | retrospective cohort | Structured interviews were conducted with the mothers and medical records were available to confirm details in about 80% of participants. | A clinical examination was carried out to check the growth parameters and detect dysmorphic features and malformations. Clinical photographs were reviewed based on whether the gestalt was suggestive of fetal anticonvulsant syndrome by a panel of blind dysmorphologists. | None. |
| Li (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023 | prospective cohort | The use of antiseizure medications on the included patients was registered by doctors and trained researchers. | After delivery, the offspring of the Women with epilepsy (WWE) were followed up by pediatricians. Offspring health was assessed by a multidisciplinary team, composed mainly of pediatricians and pediatric neurologists. | No adjustment. The exclusion criteria were as follows: (1) intelligence quotient (IQ) <70, ... (4) a voluntary termination of pregnancy of the mother’s personal choice and unrelated to fetal health. |
| Li (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 | prospective cohort | The use of antiseizure medications on the included patients was registered by doctors and trained researchers. | After delivery, the offspring of the Women with epilepsy (WWE) were followed up by pediatricians. Offspring health was assessed by a multidisciplinary team, composed mainly of pediatricians and pediatric neurologists. | No adjustment. The exclusion criteria were as follows: (1) intelligence quotient (IQ) <70, ... (4) a voluntary termination of pregnancy of the mother’s personal choice and unrelated to fetal health. |
| Mari (Carbamazepine), 2022 | retrospective cohort | Collected data at Epilepsy centers. | During each trimester of pregnancy and in the post-partum period, defned as 3 months after childbirth, women underwent periodic clinical follow-up visits through specialist medical examination and foetal screening tests. | None. |
| Mawer (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2010 | prospective cohort | The research nurse recorded personal and medical history with forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records. | Congenital abnormalities were identified from reports of fetal scans and paediatric medical examination of the baby before discharge. Major malformations were distinguished from minor anomalies using Eurocat instructions and those with chromosome abnormalities were not included. | No matching for this group of exposure. No adjustement. |
| Mawer (Carbamazepine) (Controls unexposed, disease free), 2010 | prospective cohort | The research nurse recorded personal and medical history with forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records. | Congenital abnormalities were identified from reports of fetal scans and paediatric medical examination of the baby before discharge. Major malformations were distinguished from minor anomalies using Eurocat instructions and those with chromosome abnormalities were not included. | Matched for age (within a five-year band), for parity, for residential district (postal code) and employment. No adjustement. |
| Mawer (Carbamazepine) (Controls unexposed, sick), 2010 | prospective cohort | The research nurse recorded personal and medical history with forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records. | Congenital abnormalities were identified from reports of fetal scans and paediatric medical examination of the baby before discharge. Major malformations were distinguished from minor anomalies using Eurocat instructions and those with chromosome abnormalities were not included. | No matching for this group of exposure. No adjustement. |
| McVearry (Carbamazepine), 2009 | prospective cohort | Recorded during pregnancy using seizure journals, serious adverse event reports, and clinical evaluations reported by the investigator-neurologist managing the epilepsy of enrolled mother. | Cognitive fluency and originality was assessed during a home visit with the Torrance Thinking Creatively in Action and Movement (TCAM) by blinded assessors. | None. |
| Meador (Carbamazepine), 2006 | prospective cohort | They obtained information from the patients, their seizure or medication diary, or review of their medical records. | All reports of adverse events were reviewed and classified by the principal investigator, and written reports of physical abnormalities were assessed by a board-certified medical geneticist. | No adjustment for this group of exposure. |
| Meador (Carbamazepine), 2009 | prospective cohort | They obtained information from the patients, their seizure or medication diary, or review of their medical records. | Assessors who were unaware of drug exposure evaluated cognitive outcomes with the use of the Mental Developmental Index of the Bayley Scales of Infant Development, second edition (21 to 34 months of age) and Differential Ability Scales (33 to 45 months of age). | Adjustment for maternal IQ and age, antiepileptic-drug dose, infant’s gestational age at birth, and maternal preconception use of folate. |
| Meador (Carbamazepine), 2011 | prospective cohort | They obtained information from the patients, their seizure or medication diary, or review of their medical records. | Cognitive outcomes were evaluated by blinded assessors using the Differential Ability Scales, Preschool Language Scale (4th edition), Peabody Picture Vocabulary Test (fourth edition) and Developmental Test of Visual-Motor Integration (fifth edition). | Mean age 3 index scores adjusted for maternal IQ, maternal age, dose, race, alcohol use during pregnancy and folate. |
| Meador (Carbamazepine), 2013 | prospective cohort | They obtained information from the patients, their seizure or medication diary, or review of their medical records and assessed antiepileptic drug levels for 229 (75%) mothers. | Assessors, masked to treatment, evaluated cognitive outcomes with differential ability scales, Bayley scales (BSID), children’s memory scale, behavior rating inventory of executive function, NEPSY, expressive one-word picture vocabulary test and the developmental test of visual motor integration. | Mean IQ scores are adjusted for maternal IQ and sometimes age, dose, periconceptional folate, and gestational age at delivery. For verbal and non-verbal index: maternal IQ, maternal age, gestational age, and ethnic group. For the general memory index: for maternal IQ, dose, maternal age, and alcohol use. For NEPSY: maternal IQ, gestational age, and maternal age. Only for dose for BRIEF. |
| Meador (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020 | prospective cohort | Data were obtained from participants and their medical records. | Data were obtained from participants and their medical records. | No adjustment for this group of exposure. |
| Meador (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021 | prospective cohort | Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records. | Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records. | Adjusted for mother's IQ, education level, and post-birth average Beck Anxiety Inventory (BAI) score, and child's sex, ethnicity, and birthweight. |
| Meador (Carbamazepine) (Controls unexposed, disease free), 2020 | prospective cohort | Data were obtained from participants and their medical records. | Data were obtained from participants and their medical records. | No adjustment for this group of exposure. |
| Meador (Carbamazepine) (Controls unexposed, disease free), 2021 | prospective cohort | Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records. | Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records. | Adjusted for mother's IQ, education level, and post-birth average Beck Anxiety Inventory (BAI) score, and child's sex, ethnicity, and birthweight. |
| Meador (Carbamazepine) (Controls unexposed, sick), 2020 | prospective cohort | Data were obtained from participants and their medical records. | Data were obtained from participants and their medical records. | No adjustment for this group of exposure. |
| Miškov (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2016 | prospective cohort | Data collected on pregnant women during outpatient visits to the neurologist, gynecologist and pediatrician neurologist. | Newborns were examined by pediatrician neurologist/geneticist at Clinical Department of Pediatrics and followed up yearly. Data on the control group were obtained from Clinical Department of Gynecology and Obstetrics and Clinical Department of Pediatrics . | Not specified. |
| Miškov (Carbamazepine) (Controls unexposed, disease free), 2016 | prospective cohort | Data collected on pregnant women during outpatient visits to the neurologist, gynecologist and pediatrician neurologist. | Newborns were examined by pediatrician neurologist/geneticist at Clinical Department of Pediatrics and followed up yearly. Data on the control group were obtained from Clinical Department of Gynecology and Obstetrics and Clinical Department of Pediatrics . | Not specified. |
| Miškov (Carbamazepine) (Controls unexposed, sick), 2016 | prospective cohort | Data collected on pregnant women during outpatient visits to the neurologist, gynecologist and pediatrician neurologist. | Newborns were examined by pediatrician neurologist/geneticist at Clinical Department of Pediatrics and followed up yearly. Data on the control group were obtained from Clinical Department of Gynecology and Obstetrics and Clinical Department of Pediatrics . | Not specified. |
| Nadebaum (Carbamazepine), 2011 | prospective cohort | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners. | Children participated in neuropsychological examination and all assessors were blinded to drug exposure: the Clinical Evaluation of Language Fundamentals, fourth edition and the Wechsler Intelligence Scale for Children, fourth edition were administered. | None. |
| Nulman (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 1997 | prospective cohort | At the first visit during the first trimester of pregnancy was recorded time and dose of the antiepileptic drugs before and during pregnancy. | Details were retrieved from the medical records. More informations were obtained from the mothers and by a report from the children’s pediatricians. Morphological testing were studied by a team of blinded pediatricians, neurologists and geneticists. | Matched on age, gravidity, parity, and socioeconomic class. |
| Nulman (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 1997 | prospective cohort | At the first visit during the first trimester of pregnancy was recorded time and dose of the antiepileptic drugs before and during pregnancy. | Details were retrieved from the medical records. More informations were obtained from the mothers and by a report from the children’s pediatricians. Morphological testing were studied by a team of blinded pediatricians, neurologists and geneticists. | No matching for this group of comparison. |
| Ornoy (Carbamazepine), 1996 | prospective cohort | Each woman was interviewed during pregnancy. | Children were examined physically and neurologically by a paediatrician, and evaluated by a psychologist using the Bayley developmental scales (1 year to 2.5 years of age) or McCarthy's developmental scales (above 3 years) which evaluates cognitive and motor abilities. | Matched by birth weight, gestational age, and parental socioeconomic status. No adjustment. |
| Pekoz (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023 | prospective cohort | The patients were examined by a neurologist every 2 months during pregnancy, and the use of Anti-seizure medications (ASMs) was assessed. | After deliver, and at 1 and 3 months the newborns were examined by a neonatologist. Sex, weight, height and head circumference of the newborn, whether the congenital malformation was major or minor, and perinatal or maternel death were also recorded in the database. | No adjustment. Patients without a definitive diagnosis of epilepsy, who did not attend regular follow-up visits, or who were exposed to other medications that might be teratogenic in the first trimester were excluded from this study. |
| Pekoz (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 | prospective cohort | The patients were examined by a neurologist every 2 months during pregnancy, and the use of Anti-seizure medications (ASMs) was assessed. | After deliver, and at 1 and 3 months the newborns were examined by a neonatologist. Sex, weight, height and head circumference of the newborn, whether the congenital malformation was major or minor, and perinatal or maternel death were also recorded in the database. | No adjustment. Patients without a definitive diagnosis of epilepsy, who did not attend regular follow-up visits, or who were exposed to other medications that might be teratogenic in the first trimester were excluded from this study. |
| Pennell (Carbamazepine), 2012 | prospective cohort | They obtained information from the patients, their seizure or medication diary, or review of their medical records. | Outcomes measured at birth and later ages by the labor and delivery medical team and the pediatrician, as per local standard clinical practice. Outside records were obtained for head circumference and weight. Standardized Apgar scores are measured at one and five minutes. | Controlling for the covariates tobacco use, gestational diabetes, and gestationnal age. |
| Ren (Carbamazepine) (Mixed indications), 2023 | population based cohort propective | Information on medical exposure was retrieved from the Danish Register of Medicinal Product Statistics. | Information on school performance was provided by the Danish Agency for Information Technology and Learning. The cognitive abilities are assessed using academic tests conducted from 2010 to 2014. | Adjusted for year of examination, child sex, and maternal level of education, family income, maternal age at childbirth, parity, Danish origin, maternal history of epilepsy, maternal history of any psychiatric disorder, in utero exposure to antidepressant, antipsychotics or anxiolytics. Singletons only. |
| Richards (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2019 | population based cohort retrospective | Obtained from the Pharmaceutical Collection database. Any redeemed prescription of an antiepileptic drug belonging to the Anatomical Therapeutic Chemical class N03A. Monotherapy is defined as if only one type of AED was prescribed during the exposure window. | Children are screened for their emotional and physical development with two questionnaires, the Parental Evaluation of Development Status (PEDS) tool and the Strengths and Difficulties Questionnaire (SDQ), which is completed by parents and teachers. | Adjusted for gender, ethnicity and socioeconomic deprivation. |
| Richards (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2019 | population based cohort retrospective | Obtained from the Pharmaceutical Collection database. Any redeemed prescription of an antiepileptic drug belonging to the Anatomical Therapeutic Chemical class N03A. Monotherapy is defined as if only one type of AED was prescribed during the exposure window. | Children are screened for their emotional and physical development with two questionnaires, the Parental Evaluation of Development Status (PEDS) tool and the Strengths and Difficulties Questionnaire (SDQ), which is completed by parents and teachers. | Adjusted for gender, ethnicity and socioeconomic deprivation. |
| Robert (Carbamazepine), 1986 | retrospective cohort | Questionnaires were sent to women identified in hospital records and the second collection of data was obtained from 3 maternity with computerized records. | Questionnaires were sent to women identified in hospital records and the second collection of data was obtained from 3 maternity with computerized records. | None. |
| Samrén (Carbamazepine), 1999 | retrospective cohort | Data were collected from medical records and include medication. The prescribed dose of thedrugs was also retrieved from obstetric files. | Data were collected from medical records and include information on pregnancy and child. Information on major congenital abnormalities was completed with information from the pediatrician whenever necessary. | Matched for age (±2 years) and parity of the mother, and sex, birth year, and hospital of delivery of the child. |
| Sonneveld (Carbamazepine) (Controls unexposed NOS), 1990 | prospective cohort | Since 1981, drugs ingested during pregnancy have been included in the information collected. | Propspective information was available for assessment. | None. |
| Sonneveld (Carbamazepine) (Controls unexposed, sick), 1990 | prospective cohort | Since 1981, drugs ingested during pregnancy have been included in the information collected. | Propspective information was available for assessment. | None. |
| Steegers-Theunissen (Carbamazepine), 1994 | prospective cohort | The use of antiepileptic drugs was checked in each woman by measurement of the blood concentration. Data such as antiepileptic drug treatment were collected. The consulting doctors were finally contacted to obtain additional information on treatment regimen. | The infants were examined systematically for major malformations according to the ICD9 British Paediatric Association System and for minor malformations according to Mehes and Stalder by a trained research fellow. | None. |
| The NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022 | prospective cohort | Women were questioned with a computer-assisted telephone interview 3 times. | Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist. | No adjustment for this group of comparison. |
| The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 | prospective cohort | Women were questioned with a computer-assisted telephone interview 3 times. | Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist. | Not specified. |
| Thomas (Carbamazepine), 2022 | prospective cohort | The details of Antiseizure medications exposure were extracted from the clinical records in the registry. | Assessment of intelligence and language was performed with the Wechsler Intelligence Scale for Children (WISC 4) or Adult (if > 18 years) and clinical examination of language fundamentals (CELF 4). The assessors were blinded to the details of the antenatal antiseizure medications exposure. | None. |
| Thomas (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021 | prospective cohort | Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them. | Screening for major congenital malformation with antenatal screening by serum alpha fetoprotein estimation and detailed anomaly scan between 12 and 18 weeks of pregnancy; physical examination at birth, at 3 months of age (at least) and at 1 year of age if possible. | No adjustment for this group of comparison. |
| Thomas (Carbamazepine) (Controls unexposed, disease free), 2021 | prospective cohort | Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them. | Screening for major congenital malformation with antenatal screening by serum alpha fetoprotein estimation and detailed anomaly scan between 12 and 18 weeks of pregnancy; physical examination at birth, at 3 months of age (at least) and at 1 year of age if possible. | None. |
| Thomas (Carbamazepine) (Controls unexposed, sick), 2021 | prospective cohort | Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them. | Screening for major congenital malformation with antenatal screening by serum alpha fetoprotein estimation and detailed anomaly scan between 12 and 18 weeks of pregnancy; physical examination at birth, at 3 months of age (at least) and at 1 year of age if possible. | Adjusted for age and educational status of mother, and epilepsy class. |
| Thomas a (Carbamazepine), 2008 | nested case control | The maternal use of antiepileptic drugs is recorded in the protocol forms from the month prior to the last menstrual period through the entire pregnancy and postpartum period on a monthly basis. | A cardiologist blinded to antiepileptic drugs exposure of the infants carries out a clinical examination and echocardiogram on all infants. A second cardiologist confirmed malformation whenever required. | None. |
| Thomas b (Carbamazepine), 2008 | prospective cohort | The daily dosage of antiepileptic drugs for each month of pregnancy was recorded. | The Developmental Assessment Scale for Indian Infants (DAS II) which is an Indian adaptation of the Bayley Scale of Infant Development was administered. The same team of physicians (blinded to exposure) evaluated all children for Mental Developmental Quotient and Motor Developmental Quotient. | None. |
| Titze (Carbamazepine) (Controls unexposed, disease free), 2008 | prospective cohort | The pregnant women were asked to continuously monitor their treatment. | In adolescents, the German versions of the revised Wechsler Intelligence Scales for children and for adults were applied. | Matched for socioeconomic status (SES), nicotine consumption in the last trimester, maternal age at birth, parity, and number of previous abortions. No adjustment for this group of exposure. |
| Titze (Carbamazepine) (Controls unexposed, sick), 2008 | prospective cohort | The pregnant women were asked to continuously monitor their treatment. | In adolescents, the German versions of the revised Wechsler Intelligence Scales for children and for adults were applied. | No matching for this group of comparison. No adjustment for this group of exposure. |
| Tomson (Carbamazepine), 2018 | prospective cohort | Information obtained during early pregnancy and follow-up by the treating physician who transferred it online to a EURAP national coordinator. He then, reviewed the reports for completeness and accuracy before transmission to the EURAP central database. | Abnormalities in the offspring were reported descriptively by enrolling physicians These reports were reviewed and classified (2005 EUROCAT criteria) by an outcome committee unaware of the type of exposure. Supplementary information from the reporting physician can be request. | None. |
| Tomson (Carbamazepine), 2015 | prospective cohort | The data concerning treatment at the time of conception are obtained by the physicians responsible for the women’s care and transferred online. (Intention-to-treat principle). | Information is collected by the reporting physician, before being forwarded to a national coordinator who then sends it to the central database. | No adjustment for this group of exposure. |
| Trivedi (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2018 | prospective cohort | Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them. | Women were under regular antenatal follow up by the obstetricians. | No adjustment for this group of comparison. |
| Trivedi (Carbamazepine) (Controls unexposed, sick), 2018 | prospective cohort | Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them. | Women were under regular antenatal follow up by the obstetricians. | Adjusted for enrollment status, age at conception, type of epilepsy, folic acid use in pregnancy, seizures in pregnancy, Generalised Tonic Clonic Seizures in pregnancy, prior spontaneous fetal loss, parental major congenital malformation. |
| Vajda (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2019 | prospective cohort | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records. | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records. | None. |
| Vajda (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2018 | prospective cohort | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners. | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners. | None. |
| Vajda (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2013 | prospective cohort | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners. | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners. | None. |
| Vajda (Carbamazepine) (Controls unexposed, sick), 2019 | prospective cohort | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records. | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records. | None. |
| Vajda (Carbamazepine) (Controls unexposed, sick), 2018 | prospective cohort | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners. | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners. | None. |
| Vajda (Carbamazepine) (Controls unexposed, sick), 2013 | prospective cohort | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners. | Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners. | None. |
| Van der Pol (Carbamazepine) (Controls unexposed, disease free), 1991 | prospective cohort | The dosages of antiepileptic drugs were constant throughout pregnancy. | An age-specific neurologic examination conducted by an examiner. Three Dutch tests for reading, spelling and arithmetic were applied. Assessment of child's behavior with parents and teachers questionnaires, the child behavior check list and the children's behavior questionnaire (teachers only). | Matched for their mother's parity and for birth weight, gestational age, sex, age at follow-up, and social class. |
| Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 | prospective cohort | The dosages of antiepileptic drugs were constant throughout pregnancy. | An age-specific neurologic examination conducted by an examiner. Three Dutch tests for reading, spelling and arithmetic were applied. Assessment of child's behavior with parents and teachers questionnaires, the child behavior check list and the children's behavior questionnaire (teachers only). | No matching for this group of exposure. |
| Vanya (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2015 | retrospective cohort | The epilepsy-related data evaluated included antiepileptic drugs therapy (NOS). | The evaluated parameters were minor or major congenital malformation (NOS). | None. |
| Vanya (Carbamazepine) (Controls unexposed, sick), 2015 | retrospective cohort | The epilepsy-related data evaluated included antiepileptic drugs therapy (NOS). | The evaluated parameters were minor or major congenital malformation (NOS). | None. |
| Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 | population based cohort retrospective | A standardised notification form is filled in from the first prenatal visit with the general practitioner until discharge and transferred to the database by practitioners attending the delivery. (According to ATC Classification System). | A standardised notification form is filled in from the first prenatal visit until discharge and transferred to the database by practitioners attending the delivery. (Coded according to ICD-10). Additional information on congenital malformations came from Norwegian pediatric wards. | No adjustment for this group of comparison. |
| Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) a, 2013 | prospective cohort | Reported by the mother in the first MoBa questionnaire (weeks 13-17) as well as recorded in the compulsory Medical Birth Registry by the attending physician and midwife at delivery. | Parent-reported screening tools: Ages and stages questionnaire, Bailey Scales of Infant Development, and the Infant Characteristics Questionnaire. | No adjustment for this group of comparison. |
| Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) b, 2013 | prospective cohort | Questionnaires were filled out by the mothers (at gestational week 13–17) and medical hospital-records were examined to validate the self-reported use of antiepileptic drugs during pregnancy. | Parent-reported screening tools: The Ages and Stages Questionnaire, The 40-item Social Communication Questionnaire, the Modified Checklist for Autism in Toddlers, the 14-item Early Screening of Autistic Traits, items from the Child Behaviour Checklist and DSM-IV and the Child Behaviour Checklist. | No adjustment for this group of comparison. |
| Veiby (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2014 | population based cohort retrospective | A standardised notification form is filled in from the first prenatal visit with the general practitioner until discharge and transferred to the database by practitioners attending the delivery. (According to ATC Classification System). | A standardised notification form is filled in from the first prenatal visit until discharge and transferred to the database by practitioners attending the delivery. (Coded according to ICD-10). Additional information on congenital malformations came from Norwegian pediatric wards. | Adjusted for maternal age, parity, smoking, periconceptional folate use, and chronic disease other than epilepsy. |
| Veiby (Carbamazepine) (Controls unexposed, disease free) a, 2013 | prospective cohort | Reported by the mother in the first MoBa questionnaire (weeks 13-17) as well as recorded in the compulsory Medical Birth Registry by the attending physician and midwife at delivery. | Parent-reported screening tools: Ages and stages questionnaire, Bailey Scales of Infant Development, and the Infant Characteristics Questionnaire. | Adjusted for maternal age, parity, education, folate supplementation, smoking, depression/anxiety, breastfeeding (number of months), and child malformation. |
| Veiby (Carbamazepine) (Controls unexposed, disease free) b, 2013 | prospective cohort | Questionnaires were filled out by the mothers (at gestational week 13–17) and medical hospital-records were examined to validate the self-reported use of antiepileptic drugs during pregnancy. | Parent-reported screening tools: The Ages and Stages Questionnaire, The 40-item Social Communication Questionnaire, the Modified Checklist for Autism in Toddlers, the 14-item Early Screening of Autistic Traits, items from the Child Behaviour Checklist and DSM-IV and the Child Behaviour Checklist. | Adjusted for maternal age, parity, education, smoking, periconceptional folate use, (and child low birth weight anxiety/depression, and malformation for neurodevelopmental) and maternal body weight in weight outcomes. |
| Veiby (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014 | population based cohort retrospective | A standardised notification form is filled in from the first prenatal visit with the general practitioner until discharge and transferred to the database by practitioners attending the delivery. (According to ATC Classification System). | A standardised notification form is filled in from the first prenatal visit until discharge and transferred to the database by practitioners attending the delivery. (Coded according to ICD-10). Additional information on congenital malformations came from Norwegian pediatric wards. | No adjustment for this group of comparison. |
| Veiby (Carbamazepine) (Controls unexposed, sick) a, 2013 | prospective cohort | Reported by the mother in the first MoBa questionnaire (weeks 13-17) as well as recorded in the compulsory Medical Birth Registry by the attending physician and midwife at delivery. | Parent-reported screening tools: Ages and stages questionnaire, Bailey Scales of Infant Development, and the Infant Characteristics Questionnaire. | No adjustment for this group of comparison. |
| Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 | prospective cohort | Questionnaires were filled out by the mothers (at gestational week 13–17) and medical hospital-records were examined to validate the self-reported use of antiepileptic drugs during pregnancy. | Parent-reported screening tools: The Ages and Stages Questionnaire, The 40-item Social Communication Questionnaire, the Modified Checklist for Autism in Toddlers, the 14-item Early Screening of Autistic Traits, items from the Child Behaviour Checklist and DSM-IV and the Child Behaviour Checklist. | No adjustment for this group of comparison. |
| Videman (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2016 | prospective cohort | Exposure data (including daily doses and serum levels for oxcarbazepine, carbamazepine, valproic acid, lamotrigine, and levetiracetam) were obtained prospectively at outpatient visits taking place every trimester and postnatally. | The first author performed the tests. The Griffiths Mental Developmental Scale was used to evaluate the developmental status of the infant. To assess the clinical neurological status, we used the Hammersmith Infant Neurological Examination (HINE). All examiners were blinded | No adjustment for this group of exposure. |
| Videman (Carbamazepine) (Controls unexposed, disease free), 2016 | prospective cohort | Exposure data (including daily doses and serum levels for oxcarbazepine, carbamazepine, valproic acid, lamotrigine, and levetiracetam) were obtained prospectively at outpatient visits taking place every trimester and postnatally. | The first author performed the tests. The Griffiths Mental Developmental Scale was used to evaluate the developmental status of the infant. To assess the clinical neurological status, we used the Hammersmith Infant Neurological Examination (HINE). All examiners were blinded | No adjustment for this group of exposure. |
| Viinikainen (Carbamazepine) (Controls unexposed, disease free) a, 2006 | prospective cohort | Obstetric data derived from the pregnancy registry and supplemented with medical records. And plasma levels of the antiepileptic drugs were monitoring during pregnancy at each control visit. | Reviewed through pregnancy charts, birth reports, medical records, including discharge notes of the pediatrician and control visits. | No adjustment for this group of exposure. |
| Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006 | prospective cohort | Obstetric data derived from the pregnancy registry and supplemented with medical records. And plasma levels of the antiepileptic drugs were monitoring during pregnancy at each control visit. | Reviewed through pregnancy charts, birth reports, medical records, including discharge notes of the pediatrician and control visits. | No adjustment for this group of comparison. |
| Viinikainen (Carbamazepine) b, 2006 | prospective cohort | The medical records of the children and their mothers were reviewed separately by two of the authors. | Cognitive and neuropsychological functioning were evaluated by a neuropsychologist. Neurological functioning was assessed with Touwen’s test and behavioral problems with Conners' Teacher Rating Scale. Medical records of the children and their mothers were reviewed separately by two authors. | No age and gender-matched for this group of exposure. |
| Vinten (Carbamazepine), 2005 | retrospective cohort | The women recruited were initially interviewed to ascertain information including the antiepileptic drug dose throughout the pregnancy. Clinical records were used to confirm the medical information. | Each child received a physical and neurologic examination. The Wechsler Intelligence Scale for Children III was administered. | None. |
| Waters (Carbamazepine) (Controls unexposed, disease free), 1994 | prospective cohort | An attending neurologist took a history, performed an examination, and monitored the administration of antiepileptic drugs throughout the pregnancy. Documented at each visit on a standard form. | Infants underwent a standardized examination by a physician and/or nurse trained to recognize major and minor anomalies. Data from the obstetric clinic and the infants' delivery charts. | None. |
| Waters (Carbamazepine) (Controls unexposed, sick), 1994 | prospective cohort | An attending neurologist took a history, performed an examination, and monitored the administration of antiepileptic drugs throughout the pregnancy. Documented at each visit on a standard form. | Infants underwent a standardized examination by a physician and/or nurse trained to recognize major and minor anomalies. Data from the obstetric clinic and the infants' delivery charts. | None. |
| Wide (Carbamazepine), 2000 | prospective cohort | Mothers attended the outpatient clinic for pregnant women with epilepsy at the department of neurology where drug plasma levels were determined at monthly intervals. | One of the participating paediatricians organize the examination of the newborn infant within 4 days of birth. A blind child psychologist performed the Griffiths’ test, in the child’s home at 9 months after birth. Data on birthweight were obtained from medical records. | Matched for gestational age and mode of delivery. Sex-matched control infants were found for a majority of subjects. |
| Wiggs (Carbamazepine), 2020 | population based cohort retrospective | Authors defined exposure using Anatomical Therapeutic Chemical codes for maternal-reported atiseizure medication use. They cross-referenced maternal self-reports against official records of filled prescriptions in The Prescribed Drug Register to verified previous findings of high agreement. | Inpatient and outpatient diagnoses made by specialists recorded in the National Patient Register (NPR) (ICD-10 codes F84.0, F84.1, F84.5 and F90). And for ADHD by either diagnoses in the NPR or prescriptions for stimulant medication in the Prescribed Drug Register. | Maternal and paternal characteristics included age, highest education, cohabitation status, and country of origin, neighborhood deprivation and averaged maternal and paternal disposable income, parental psychiatric and behavioral problems, inpatient diagnosis of seizures in the year before pregnancy, birth order, child sex, and maternal smoking during pregnancy and concurrent medication use. |
| Wood (Carbamazepine), 2015 | prospective cohort | Details are obtained by four in-depth telephone interviews with the women. And treating doctors are contacted to confirm medical details. | Assessments with the Childhood Autism Rating Scale (CARS) were conducted by two authors blinded to drug exposure status of the child and clinical diagnosis of the mother and a consensus meetings conducted to confirm scoring. | None. |
| Yerby (Carbamazepine), 1992 | prospective cohort | Women with epilepsy had a determination of antiepileptic drug concentrations. They were scheduled for monthly visits and with their babies two times post partum | The infants of both case and control mothers were examined by a blinded developmental pediatrician. A checklist for major and minor malformations was used, and facial measurements were taken. | None. |
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