Fluvoxamine

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Ames, 2021	case control	Maternal use of SSRIs during pregnancy were ascertained from all participants in three ways: self-report in a telephone interview shortly after study enrollment (SEED Caregiver Interview), self-report on the SEED maternal medical history form, and abstraction from prenatal medical records.	Children completed a multistage process. 1) Mother (mainly) completed the Social Communication Questionnaire. 2) Gold standard clinical assessments: Autism Diagnostic Observation Schedule, Autism Diagnostic Interview Revised, Mullen Scales of Early Learning and Vineland Adaptive Behavior Scales.	Adjusted ORs were adjusted by the following variables: maternal age (continuous), maternal race, maternal education, family income, and smoking history.
Bérard, 2017	retrospective cohort (claims database)	Prescription fillings dispensed to women identified in the cohort from the Quebec public prescription drug insurance database.	Major congenital malformations were identified in the Régie de l’assurance maladie du Québec (RAMQ) and the Quebec hospitalization archives (MedEcho) databases defined according to International Classification of Diseases (9th-10th).	Adjusted for maternal age, welfare status, diabetes, hypertension, asthma and other medication uses including benzodiazepines as well as healthcare usage in the year prior and during the first trimester.
Bérard, 2016	retrospective cohort (claims database)	The Public Prescription Drug Insurance database of Québec (drug name, start date, dose, and duration). Data on prescription filling for AD were validated against medical records and maternal reports.	The medical service databases: The Régie de l’assurance maladie du Québec (RAMQ): diagnoses, medical procedures, prescribers, and socioeconomic status of women and children), the Québec centralized hospitalization archives (MedEcho) and the Québec Statistics database.	Adjusted for use of ADs 1 year before the first day of gestation, use of ADs in the first trimester, infant characteristics (sex, year of birth), and maternal variables (maternal age at first day of gestation, high school completed, recipient of social assistance, living alone, chronic or gestational hypertension, chronic or gestational diabetes, and other psychiatric disorders).
Colvin, 2012	retrospective cohort (claims database)	The national Pharmaceutical Benefits Scheme (PBS), a claims database that includes 80% of all prescriptions dispensed in Australia.	The Western Australia Data Linkage System (WADLS), which contains data from the Hospital Morbidity Data System, the Midwives’ Notification System, the WA Registry of Births and Deaths and the WA Register of Developmental Anomalies. The ICD-10-AM is used.	None for these outcomes.
Dandjinou, 2019	nested case control	The Quebec Prescription Drug Insurance Database (drug name, start date, dosage and duration).	The medical service database (RAMQ: diagnoses and medical procedures), the Hospitalisation Archive Database (MedEcho: in-hospital diagnoses and procedures) and the Quebec Statistics Database (Institut de la statistique du Québec (ISQ):patient sociodemographic information).	Matched for gestational age and year of pregnancy. Adjusted for maternal age, area of residence, receipt of social assistance during pregnancy, physician-based diagnoses or filled prescriptions of medications for chronic comorbidities; physician-based diagnoses of maternal diseases; medication use other than antidepressants; history of antidepressant use and health service utilisation.
De Vera, 2012	nested case control	The Quebec’s Public Prescription Drug Insurance Plan.	Linkage of three administrative databases: (i) Régie de l’Assurance Maladie du Québec (RAMQ), (ii) MED-ECHO and (iii) Institut de la Statistique du Québec (ISQ).	Cases and controls matched on gestational age. Multivariable models were adjusted for sociodemographic variables, depression, anxiety, other comorbid medical conditions, medication use and health care utilization.
Dubnov-Raz, 2008	prospective cohort	Not specified.	For the neontates outcomes their medical charts and ECG tracings were extracted. For the purpose of this study, ECGs were interpreted by a single experienced pediatric cardiologist (Dr Fogelman), who was blinded to drug exposure.	Controls matched on gestational age. Exclusion of neonates born to women treated with any other chronic medication during pregnancy (whether known as QT prolonging or not), with gestational diabetes or hypothyroidism, with Apgar scores <7 (either 1 or 5 minutes) and those with cardiac structural abnormalities identified by echocardiography.
Einarson, 2009	prospective cohort	During the initial telephone contact, details of exposure and concurrent exposures are recorded on a standardized questionnaire.	At the follow-up interview, gestational findings, fetal outcomes, and neonatal health are documented on a structured form by telephone interview with each mother. The details are then corroborated with the report of the physician caring for the baby.	The 2 whole groups were matched for maternal age, smoking, and alcohol use. But no matching for individual substance.
Furu, 2015	population based cohort retrospective	The Nordic prescription registers include data on dispensed drugs, substance, brand name, and formulation, together with date of dispensing.	From the medical birth, patient, and malformation registers data on maternal characteristics, the pregnancy and delivery, and major birth defects were retrieved.	Adjusted for maternal age, year of birth, birth order, smoking, maternal diabetes, country, and use of other prescribed drugs (antiepileptics (atC code n03), anxiolytics and hypnotics (n05b and n05C), and angiotensin converting enzyme inhibitors (C09)).
Källén, 2007	population based cohort retrospective	Drug information was obtained from routine midwife interviews at the first antenatal care center visit (in 90% before the end of week 12) using a standardized form.	Congenital malformations were identified from the Swedish Medical Birth Register, from the Register of Congenital Malformations, and from the Hospital Discharge Register.	Adjustments were made for year of birth, maternal age, parity, smoking, and !3 previous miscarriages.
Kieler, 2012	population based cohort retrospective	The prescription registers.	from the medical birth registers and th cause of death registers, infants with persistent pulmonary hypertension of the newborn identified as an ICD-10 code P29.3 or I27.0.	Adjusted for maternal age, dispensed non-steroidal anti-inflammatory drugs and antidiabetes drugs, pre-eclampsia, chronic diseases during pregnancy, country of birth, birth year, level of delivery hospital, and birth order.
Malm, 2011	population based cohort retrospective	The Drug Reimbursement Register that contains data on 98% of reimbursed prescription drug purchases.	The Medical Birth Register and the The Register of Congenital Malformations, which data on diagnoses during pregnancy and delivery and neonatal outcome data (including major malformations). Data are collected from all maternity hospitals and include all births and stillbirths.	Independent variables considered in the adjusted logistic model were maternal age at the end of pregnancy, parity, year of pregnancy ending, marital status, smoking during pregnancy, purchase of other reimbursed psychiatric drugs (including antiepileptics) during the first trimester, and maternal prepregnancy diabetes.
Nakhai-Pour, 2010	nested case control	The Régie de l’assurance maladie du Québec (RAMQ) database which provides prospectively collected data on filled prescriptions.	The Régie de l’assurance maladie du Québec (RAMQ) (physician-based diagnoses according to the ICD-9), the Med-Echo database (data on acute care hospital admissions) and the Institut de la statistique du Québec database (data on all births and deaths in Quebec).	Match. Adjusted for maternal age, social assistance status and place of residence; gestational age at index date; comorbidities (diabetes mellitus, cardiac disease, asthma, untreated thyroid disease, depression, anxiety, bipolar disorder); history of abortions; visits to physicians; duration of antidepressants; prenatal visits and other medication use in the year before and during pregnancy.
Oberlander, 2008	retrospective cohort (claims database)	PharmaNet, a province-wide network recording all prescriptions dispensed by British Columbian pharmacists outside hospitals.	Five administrative sources housed in the BC Linked Health Database: British Columbia registry of births, hospital separation records, the PharmaCare registry of subsidized prescriptions; the Medical Services Plan physician billing records; and the registry of Medical Services Plan subscribers.	None (adjustment provided for risk difference but not for relative risk or odd ratio).
Stephansson, 2013	population based cohort retrospective	The prescription registries in the Nordic countries include data on the dispensed item, substance, brand name, and formulation together with date of dispensing for more than 95% of the total outpatient population.	Information on stillbirth was obtained from the medical birth registries and neonatal and postneonatal deaths were obtained from the Nordic causes of death registries. All diagnoses and causes of death are classified according to the ICD-10 codes.	Adjusted for country and year of birth, maternal age, birth order, smoking in early pregnancy, and maternal diabetes and hypertension.
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.

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