- Medication and Pregnancy KB

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Bànhidy (Ethosuximide), 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.
Dean (Ethosuximide), 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.
Kaaja (Ethosuximide), 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 (Ethosuximide) (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 (Ethsuximide) (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.
Kilic (Ethosuximide) (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 (Ethosuximide) (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.	No adjustment for this group of comparison.
Kilic (Ethosuximide) (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 (Ethosuximide) (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 (Ethosuximide) (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.
Morrow (Ethosuximide) (Controls exposed to Lamotrigine, sick), 2006	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. Pregnancy losses with no major malformation are excluded.	No adjustment for this group of comparison.
Morrow (Ethosuximide) (Controls unexposed, sick), 2006	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. Pregnancy losses with no major malformation are excluded.	No adjustment for this group of exposure.
Samrén (Ethosuximide), 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.
Tomson (Ethosuximide), 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.
Vajda (Ethosuximide) (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 (Ethosuximide) (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.

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