Clomipramine

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Anderson, 2020	case control	Information on exposure to TCAs and other potential risk factors during pregnancy were collected by standardized telephone interviews with mothers of case and control infants, conducted 6 weeks to 24 months after the estimated date of delivery (EDD).	Case infants were ascertained through population-based birth-defects surveillance systems in 10 U.S. states. Controls were selected randomly from the same geographic areas. Clinical data were abstracted from medical records and classified by clinician geneticists and other clinicians.	No adjustment for this group of exposure.
Källen, 2013	population based cohort retrospective	The exposure data are either based on midwife interviews from the first antenatal visit (usually during weeks 10–12) or on linkage with a prescribed drug register.	Medical Birth Register (MBR) supplemented with data from the Register of Birth Defects (RCM, previously Register of Congenital Malformations) and from a Hospital Discharge Register (HDR).	Adjustment was made for year of birth, maternal age (5-year class), parity (1–4), smoking in early pregnancy (unknown, none, <10 cigarettes/day, ≥10 cigarettes per day), and BMI (unknown, <18.5, 18.5–24.9, 25–29, 9. 30–34.9, ≥35).
Kjaersgaard (Controls unexposed, NOS), 2013	population based cohort retrospective	Information on all redeemed prescriptions was obtained from the Denmark Registry of Medicinal Product Statistics.	Clinically recognized abortions were identified in the Danish National Hospital Registry, that contains data on in- and outpatient contacts in Denmark coded according to a Danish version of the 10th revision of the International Classification of Diseases (ICD-10).	No adjustment for this group of exposure.
Kjaersgaard (Controls unexposed, sick), 2013	population based cohort retrospective	Information on all redeemed prescriptions was obtained from the Denmark Registry of Medicinal Product Statistics.	Clinically recognized abortions were identified in the Danish National Hospital Registry, that contains data on in- and outpatient contacts in Denmark coded according to a Danish version of the 10th revision of the International Classification of Diseases (ICD-10).	No adjustment for this group of exposure.
Ozturk, 2016	prospective cohort	At the first contact, initiated via gynecologists, a detailed patient history form was used to notably record all drug exposures (dose, duration and timing in pregnancy).	Each newborn baby was checked at birth for signs of problems or complications.	None
Rai (Controls exposed to SSRIs), 2017	prospective cohort	Information on maternal use of antidepressants in pregnancy is derived from the medical birth register (as reported by pregnant women at their antenatal interview, at a median of 10 weeks’ gestation) and supplemented it with the prescribed drug register (available from July 2005).	Diagnostic information of autism were collected the national patient register, the Stockholm child and adolescent mental health register, and the habilitation registers (ICD-9 (299), ICD-10 (F84), or DSM-IV (299) codes).	No adjustment for this group of comparison.
Rai (Controls unexposed, disease free), 2017	prospective cohort	Information on maternal use of antidepressants in pregnancy is derived from the medical birth register (as reported by pregnant women at their antenatal interview, at a median of 10 weeks’ gestation) and supplemented it with the prescribed drug register (available from July 2005).	Diagnostic information of autism were collected the national patient register, the Stockholm child and adolescent mental health register, and the habilitation registers (ICD-9 (299), ICD-10 (F84), or DSM-IV (299) codes).	No adjustment for this group of comparison.
Rai (Controls unexposed, sick), 2017	prospective cohort	Information on maternal use of antidepressants in pregnancy is derived from the medical birth register (as reported by pregnant women at their antenatal interview, at a median of 10 weeks’ gestation) and supplemented it with the prescribed drug register (available from July 2005).	Diagnostic information of autism were collected the national patient register, the Stockholm child and adolescent mental health register, and the habilitation registers (ICD-9 (299), ICD-10 (F84), or DSM-IV (299) codes).	Models are adjusted for birth year, maternal depression, and antidepressant polypharmacy (binary variable for use of 2 or more antidepressants).
Yaris, 2005	prospective cohort	Data surveyed by the interviews.	Examinations were made by obstetric ultrasound for the mothers and birth weight and height, gestational age, APGAR scores, congenital malformation and developmental problems for the babies. Periodic checks of all the babies in the neonatal period, were made the first year, and following years.	None for this group of exposure.

master protocol