Study Type of data Exposure measurement Outcome assessment Adjustment
Andersen (control exposed to PTU), 2019 population based cohort retrospective The Danish National Prescription Register (DNPR) includes information on redeemed prescriptions of drugs coded according to the Anatomical Therapeutical Classification (ATC) system, and drugs used for the treatment of thyroid disease are included in the ATC group: H03. Information on birth defects in the child was assessed from in- and outpatient hospital diagnoses in the Danish National Hospital Register (DNHR) (16) coded according to the 10th International Classification of Disease (ICD-10). Not adjustment for this control group.
Andersen (control unexposed, disease free), 2019 population based cohort retrospective The Danish National Prescription Register (DNPR) includes information on redeemed prescriptions of drugs coded according to the Anatomical Therapeutical Classification (ATC) system, and drugs used for the treatment of thyroid disease are included in the ATC group: H03. Information on birth defects in the child was assessed from in- and outpatient hospital diagnoses in the Danish National Hospital Register (DNHR) (16) coded according to the 10th International Classification of Disease (ICD-10). Adjusted for maternal age, parity, multiple birth, origin, diabetes, and smoking.
Andersen 2014 (control unexposed, disease free), 2014 population based cohort retrospective Danish National Prescription Register. Thyroid hormones (ATC H03A) and ATD (ATC H03B) are sold solely as prescription drugs in Denmark. Information on gestational age, birth weight, and gender of the child were identified in the Medical Birth Registry. Diagnosis of birth defects was obtained from the Danish National Hospital Register. Adjusted model included birth year of the child, gender of the child, singleton/multiple pregnancy, maternal age, parity, cohabitation, maternal income, maternal origin and maternal residence.
Andersen 2017 (control exposed to PTU), 2017 population based cohort retrospective Information on maternal use of ATDs was obtained from the Swedish Prescribed Drug Register (SPDR) which holds data on all prescriptions drugs in Swedish since 2005. The Swedish Medical Birth Registry provided child characteristics (gender, gestational age at birth, birth weight, mode of delivery). Diagnoses of birth defects in the children were obtainedfrom the Swedish National Patient Register. No adjustment for the control group exposed to PTU.
Andersen 2017 (control unexposed, disease free), 2017 population based cohort retrospective Information on maternal use of ATDs was obtained from the Swedish Prescribed Drug Register (SPDR) which holds data on all prescriptions drugs in Swedish since 2005. The Swedish Medical Birth Registry provided child characteristics (gender, gestational age at birth, birth weight, mode of delivery). Diagnoses of birth defects in the children were obtained from the Swedish National Patient Register. The adjusted model included birth year of the child, maternal age, parity, type of pregnancy, body mass index, smoking and origin as categorical variables. Additional adjustment for maternal comorbidities (diabete, epilespy) as well as deviations in birth weight, gestational age at birth and mode of delivery did not change figures.
Andersen 2017 (control unexposed, sick), 2017 population based cohort retrospective Information on maternal use of ATDs was obtained from the Swedish Prescribed Drug Register (SPDR) which holds data on all prescriptions drugs in Swedish since 2005. The Swedish Medical Birth Registry provided child characteristics (gender, gestational age at birth, birth weight, mode of delivery). Diagnoses of birth defects in the children were obtainedfrom the Swedish National Patient Register. No adjustment for the control group unexposed, sick.
Azizi, 2002 retrospective cohort Women with thyrotoxicosis who had regular follow-up in the endocrine office were recalled. Physical examination was performed, weight and height were recorded. The intelligence quotient (IQ) was evaluated by the same psychologist by Wechsler preschool and primary scale of Intelligence (WPPSI). Controls were sex and age matched.
Banhidy, 2011 case control Mothers were asked to send us the prenatal maternity logbook (obstetricians recorded maternal diseases, and related drug prescriptions in this logbook, in the first prenatal care visit was between the 6th and 12th gestational week) and other medical records particularly discharge summaries. Diagnosis of Congenital Anomalies was based on the compulsory notification of physicians to the HCAR. Pathologists sent a copy of the autopsy report to the HCAR if defects were identified in stillbirths and infant deaths. Two controls matched according to sex, birth week, and district of parents' residence. Among potential confounding factors, maternal age, birth order, marital and employment status as indicators of socio-economic status, other maternal diseases and related drug treatments, in addition folic acid/multivitamin supplements were evaluated for the primary analysis. (No adjustment for treatment effect)
Barbero, 2008 case control A structured questionnaire was applied to all the mothers of eligible patients containing exposure during pregnancy, notably to acute and chronic maternal diseases, and medicines (detailed on the period/dose of MMI intake was also obtained (MMI is the only antithyroid drug available in Argentina)). Cases of choanal atresia were selected among patients of 3 hospitals in Argentina. Controls matched according to maternal age.
Chen (control exposed to PTU), 2011 retrospective cohort (claims database) Taiwan National Health Insurance Research Dataset (NHIRD) includes the cost of inpatient treatment and outpatient prescriptions. The national birth certificate registry of Taiwan include the birth dates of both infants and parents, the gestational age of the baby at birth, birth-weight... No adjustment/matched for this control group.
Chen (control unexposed, disease free), 2011 retrospective cohort (claims database) Taiwan National Health Insurance Research Dataset (NHIRD) includes the cost of inpatient treatment and outpatient prescriptions. The national birth certificate registry of Taiwan include the birth dates of both infants and parents, the gestational age of the baby at birth, birth-weight... Comparison group matched on maternal age.
Chen (control unexposed, sick), 2011 population based cohort retrospective Taiwan National Health Insurance Research Dataset (NHIRD) includes the cost of inpatient treatment and outpatient prescriptions. The national birth certificate registry of Taiwan include the birth dates of both infants and parents, the gestational age of the baby at birth, birth-weight... Adjusted for maternal education, anaemia, hyperlipidaemia, pregestational diabetes, pregestational hypertension, hyperemesis gravidarum and infant’s gender and birth order.
Clementi, 2010 case control Not specified. The coverage, structure, methods, and sources of ascertainment, de- scribed elsewhere, varied from program to program (12 surveillance programs included). These data were reviewed for malformation classification by a clinician with expertise in genetics and dysmorphology to separate subjects of isolated major malformations from those of multiple congenital anomalies. Analyses were stratified by surveillance program. Further adjustment could include covariates such as year of birth, maternal age, and parity.
Di Gianantonio, 2001 prospective cohort Prospective data were collected at the time of the inquiry and included questions on commercial preparation used, its dosage, indication for use, and the time during the pregnancy when it was taken. All women or their doctors, or both, were contacted by the TIS staff by mail or telephone. The information obtained included outcome of pregnancy (termination, abortion, or delivery); birth weight, ... ; perinatal complications, and the presence and type of any major congenital malformation. None
Dwarakanath (control exposed to PTU), 1999 retrospective cohort Women were advised regarding antithyroid drug during their pregnancies in the hospital. Women were followed-up in the antenatal clinic for any pregnancy-related complications and fetal growth. All deliveries were conducted in the hospital. None
Gianetti (control exposed to PTU), 2015 retrospective cohort Records were reviewed retrospectively in order to collect data notably on specific antithyroid drug used and its dose. Clinical and biochemical notes, information on delivery and postpartum records were reviewed retrospectively in order to assess maternal and fetal outcomes. None
Gianetti (control unexposed, sick), 2015 retrospective cohort Records were reviewed retrospectively in order to collect data notably on specific antithyroid drug used and its dose. Clinical and biochemical notes, information on delivery and postpartum records were reviewed retrospectively in order to assess maternal and fetal outcomes. None
Hawken (control exposed to PTU), 2016 retrospective cohort Review of the files obtained by hospitals in the region after having contacted hospitals and open-care endocrinologists working in the Poitou-Charentes region. Review of the files obtained by hospitals in the region after having contacted hospitals and open-care endocrinologists working in the Poitou-Charentes region. We also focused on foetal monitoring (ultrasound and laboratory) and the clinical and biological characteristics of the neonate. None
Khoury, 1989 case control Mothers of cases and controls were interviewed using a computer-assisted telephone questionnaire, notably whether or not they took medications for their illness, the names of specific medications, duration of treatment and intake of such medications during the index pregnancy. Cases came from the Metropolitan Atlanta Congenital Defects Programme (MACDP). Babies with malformations are ascertained via multiple methods by Centres for Disease Control trained staff, including review of hospital records, vital records, cytogenetic laboratories and specialised clinics. Odds ratios are controlled for race (matched controls), hospital of birth (matched controls), quarter of birth (matched controls), maternal age, education, and alcohol intake.
Korelitz (control exposed to PTU), 2013 retrospective cohort (claims database) Prescription drug claims were used to determine ATD therapy. In the administrative claims database, pregnancies and imputed gestational age were identified based on the diagnosis code associated with the pregnancy outcome using an algorithm. No adjustment for this control group
Korelitz (control unexposed, disease free), 2013 retrospective cohort (claims database) Prescription drug claims were used to determine ATD therapy. In the administrative claims database, pregnancies and imputed gestational age were identified based on the diagnosis code associated with the pregnancy outcome using an algorithm. Odds ratios (ORs), CIs, and p-values were obtained from lo- gistic regression models that adjusted for the mother’s age.
Korelitz (control unexposed, sick), 2013 retrospective cohort (claims database) Prescription drug claims were used to determine ATD therapy. In the administrative claims database, pregnancies and imputed gestational age were identified based on the diagnosis code associated with the pregnancy outcome using an algorithm. No adjustment for this control group
Lo (control exposed to PTU), 2015 retrospective cohort (claims database) Kaiser Permanente Northern California (KPNC) is a large integrated health care delivery system. Pharmacologic exposures were obtained from health plan electronic databases. Kaiser Permanente Northern California (KPNC) allowed to track gestational age and weight at birth, neonatal intensive care unit (NICU) admissions, neonatal diagnoses, and outcomes. Chart review was conducted by a neonatologist (MK) to adjudicate congenital anomalies in all infants exposed to ATDs. None for comparison with PTU
Lo (control unexposed, sick), 2015 retrospective cohort (claims database) Kaiser Permanente Northern California (KPNC) is a large integrated health care delivery system. Pharmacologic exposures were obtained from health plan electronic databases. Kaiser Permanente Northern California (KPNC) allowed to track gestational age and weight at birth, neonatal intensive care unit (NICU) admissions, neonatal diagnoses, and outcomes. Chart review was conducted by a neonatologist (MK) to adjudicate congenital anomalies in all infants exposed to ATDs. None for comparison with Thyrotoxicosis but no gestational ATD group control
McCarroll (Buckinghamshire control group), 1976 retrospective cohort Carbimazole was administered in every case during the first two trimesters of pregnancy then reduced in the last trimester. Psychological testing of the children were carried out for the following four factors: (1) physical health, (2) hospitalization, (3) behavioural health, and (4) inteligence quotient (IQ) by Wechsler scale. None
McCarroll (Northern Ireland control group), 1976 retrospective cohort Carbimazole was administered in every case during the first two trimesters of pregnancy then reduced in the last trimester. Psychological testing of the children were carried out for the following four factors: (1) physical health, (2) hospitalization, (3) behavioural health, and (4) inteligence quotient (IQ) by Wechsler scale. None
Momotani, 1984 retrospective cohort Treatment administered by physicians in the clinics. At their first visit after delivery, a doctor interviewed the mothers about the congenital malformations diagnosed by the obstetricians. Afterwards the doctor conducted examinations of the malformed infants. None
Momotani (control exposed to PTU), 1997 prospective cohort Administration of MMI or PTU by investigators. Blood samples were obtained from the women and from the umbilical cords of their respective infants at the time of delivery. Informed consent for blood drawing was obtained from every mother who was studied. None
Seo (control exposed to PTU), 2018 retrospective cohort (claims database) National Health Insurance (NHI) database All inpatient admissions and outpatient visits with a primary or additional diagnosis of congenital malformations No adjustement for the comparison with PTU alone
Seo (control unexposed, NOS), 2018 retrospective cohort (claims database) National Health Insurance (NHI) database All inpatient admissions and outpatient visits with a primary or additional diagnosis of congenital malformations Adjustement for maternal age, birth year, multiple pregnancies, and infant sex.
Wing (control exposed to PTU), 1994 cohort The patients were followed up prospectively during pregnancy with treatment administration. Retrospectively, the maternal and fetal outcomes were reviewed from clinic, labor, delivery, and postpartum records. No statistical adjustment was made for multiple end points.
Wing (control unexposed, sick), 1994 cohort The patients were followed up prospectively during pregnancy with treatment administration. Retrospectively, the maternal and fetal outcomes were reviewed from clinic, labor, delivery, and postpartum records. No statistical adjustment was made for multiple end points.
Yoshihara (control exposed to PTU), 2012 retrospective cohort Review of the medical records. During the mothers’ 1st visit after delivery, a physician interviewed them about GA at delivery, birth weight, and the presence and type of major or minor birth defects in their infant. In case of malformation, the doctor corresponded with the gynecologist to obtain details on anomalies. No adjustment for comparison with PTU group as control.
Yoshihara (control unexposed, sick), 2012 retrospective cohort Review of the medical records. During the mothers’ 1st visit after delivery, a physician interviewed them about GA at delivery, birth weight, and the presence and type of major or minor birth defects in their infant. In case of malformation, the doctor corresponded with the gynecologist to obtain details on anomalies. Maternal age and mother’s thyroid status in the first trimester of pregnancy were also included in the models to adjust for confounding.
Yoshihara (Controls exposed to PTU), 2021 retrospective cohort Not specified (Pregnant patients being treated at the institution were informed during their pregnancy that they would be asked about the outcome of their pregnancy after delivery). At the first visit after delivery and 1 year after delivery, a physician interviewed mothers, with a structured questionnaire about the outcome of pregnancy, gestational age at delivery, birth weight, and the presence and type of major or minor birth defects. None
Yoshihara (Controls unexposed, sick), 2021 retrospective cohort Not specified (Pregnant patients being treated at the institution were informed during their pregnancy that they would be asked about the outcome of their pregnancy after delivery). At the first visit after delivery and 1 year after delivery, a physician interviewed mothers, with a structured questionnaire about the outcome of pregnancy, gestational age at delivery, birth weight, and the presence and type of major or minor birth defects. None

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