Olanzapine

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Boden (Control exposed to other antipsyhcotics), 2012	population based cohort retrospective	Swedish Prescribed Drug Register contains information on all prescriptions filled in Sweden. The information is obtained by midwives and attending physicians in connection with visits and hospitalizations from the antenatal visit through the neonatal period.	Diagnosis recorded in the Medical Birth Register. The information is obtained by midwives and attending physicians in connection with visits and hospitalizations from the antenatal visit through the neonatal period.	Singleton only. No adjustment for this comparison group.
Boden (Control unexposed, NOS), 2012	population based cohort retrospective	Swedish Prescribed Drug Register contains information on all prescriptions filled in Sweden. The information is obtained by midwives and attending physicians in connection with visits and hospitalizations from the antenatal visit through the neonatal period.	Diagnosis recorded in the Medical Birth Register. The information is obtained by midwives and attending physicians in connection with visits and hospitalizations from the antenatal visit through the neonatal period.	As potential confounders, are included maternal country of origin, smoking, height, and cohabitation status at the first antenatal visit; maternal age when giving birth; and birth order of the infant.
Bruno, 2024	population based cohort retrospective	Data on filled or reimbursed prescriptions were obtained from the nation prescription registries.	Information on child neurodevelopmental disorders was ascertained from ICD-10 codes recorded in specialist care registers. Poor academic performance in the first national standardized school test administered was assessed using national education registers.	Singletons only. Adjusted for child’s country of birth, year of birth and sex, maternal country of birth, education, age, parity, cohabitation, smoking status, and body mass index (BMI) in early pregnancy, other medication use, known or suspected teratogen use, maternal comorbidity during pregnancy, and psychiatric diagnosis.
Chan (Controls exposed to FGA), 2024	retrospective cohort (claims database)	The exposure data were obtained from the Clinical Data Analysis and Reporting System (CDARS), including prescribing and dispensing records.	The outcomes data were obtained from the Clinical Data Analysis and Reporting System (CDARS), including clinical information: diagnoses, attendances to outpatient clinics and emergency departments, hospital admissions (ICD-9-classification).	Singleton. Exclusion of fetal alcohol syndrome, abnormalities due to maternal infection or exposure to known teratogens. No adjustment for this group of comparison.
Chan (Controls unexposed, general pop), 2024	retrospective cohort (claims database)	The exposure data were obtained from the Clinical Data Analysis and Reporting System (CDARS), including prescribing and dispensing records.	The exposure data were obtained from the Clinical Data Analysis and Reporting System (CDARS), including prescribing and dispensing records.	Singleton. Exclusion of fetal alcohol syndrome, abnormalities due to maternal infection or exposure to known teratogens. PS-weighted logistic regression models with age, parity, maternal pre-existing diseases including diabetes, hypertension, epilepsy, physical comorbidity burden, psychiatric disorders, alcohol use disorders, history of postpartum depression / psychosis, other medications...
Chan (Controls unexposed, sick), 2024	retrospective cohort (claims database)	The exposure data were obtained from the Clinical Data Analysis and Reporting System (CDARS), including prescribing and dispensing records.	The outcomes data were obtained from the Clinical Data Analysis and Reporting System (CDARS), including clinical information: diagnoses, attendances to outpatient clinics and emergency departments, hospital admissions (ICD-9-classification).	Singleton. Exclusion of fetal alcohol syndrome, abnormalities due to maternal infection or exposure to known teratogens. PS-weighted logistic regression models with age, parity, maternal pre-existing diseases including diabetes, hypertension, epilepsy, physical comorbidity burden, psychiatric disorders, alcohol use disorders, history of postpartum depression / psychosis, other medications...
Ellfolk (Controls exposed to FGA), 2021	population based cohort retrospective	Data from the Drugs and Pregnancy database which includes data from the Prescription Register.	Data from the Medical Birth Register, the Abortion Register, the Register of Congenital Malformations (ICD-9 diagnoses).	Adjusted for year of delivery, maternal age at delivery, parity, prepregnancy BMI, cohabitation, smoking, SES, other psychiatric drugs, psychotic and other severe mental disorders, diabetes (pre- and/or gestational). Alcohol use is not routinely collected in the MBR and could therefore not be included in analyses. Exclusion of pregnancies exposed to known teratogens.
Ellfolk (Controls unexposed NOS), 2021	population based cohort retrospective	Data from the Drugs and Pregnancy database which includes data from the Prescription Register.	Data from the Medical Birth Register, the Abortion Register, the Register of Congenital Malformations (ICD-9 diagnoses).	Matched for year of birth. Adjusted for year of delivery, maternal age at delivery, parity, prepregnancy BMI, cohabitation, smoking, SES, other psychiatric drugs, psychotic and other severe mental disorders, diabetes (pre- and/or gestational). Alcohol use is not routinely collected in the MBR and could therefore not be included in analyses. Exclusion of pregnancies exposed to known teratogens.
Habermann (Control exposed to FGA), 2013	prospective cohort	Data ascertainment was performed using 2 structured questionnaires at (1) the first contact and (2) 8 weeks after the estimated date of birth. A detailed history of drug use is recorded at the first contact.	Follow up is especially focused on congenital anomalies and postnatal disorders. For this purpose, during interview, the hospital discharge summaries are asked for.	No adjustment/match for this exposed group.
Habermann (Unexposed control), 2013	prospective cohort	Data ascertainment was performed using 2 structured questionnaires at (1) the first contact and (2) 8 weeks after the estimated date of birth. A detailed history of drug use is recorded at the first contact.	Follow up is especially focused on congenital anomalies and postnatal disorders. For this purpose, during interview, the hospital discharge summaries are asked for.	No adjustment/match for this exposed group.
Huybrechts (Controls unexposed, NOS), 2023	population based cohort retrospective	Exposure to atypical and typical antipsychotics was defined based on filling 1 or more prescriptions of the respective drug class during the first trimester, the period for organogenesis. => Prescription databases.	Nordic Countries: outcomes are defined based on data from the Medical Birth, Malformation and/or Patient Registers from the date of birth to one year after birth. USA: claims in infant record between birth and birth more 90 days and/or in the maternal record, using both in- and out-patient data.	Propensity score approach to control for potential confounders: demographic factors (maternal age..), treatment indications/mental disorders, maternal/obstetrical conditions (hypertension, diabetes, ...), lifestyle behaviors (tobacco, alcohol, ...), other medications, and health care utilization metrics. Exclusion of pregnancies exposed to a known teratogenic medication. Singleton births only.
Huybrechts (Controls unexposed, sick), 2023	population based cohort retrospective	Exposure to atypical and typical antipsychotics was defined based on filling 1 or more prescriptions of the respective drug class during the first trimester, the period for organogenesis. => Prescription databases.	Nordic Countries: outcomes are defined based on data from the Medical Birth, Malformation and/or Patient Registers from the date of birth to one year after birth. USA: claims in infant record between birth and birth more 90 days and/or in the maternal record, using both in- and out-patient data.	Propensity score approach to control for potential confounders: demographic factors (maternal age..), treatment indications/mental disorders, maternal/obstetrical conditions (hypertension, diabetes, ...), lifestyle behaviors (tobacco, alcohol, ...), other medications, and health care utilization metrics. Exclusion of pregnancies exposed to a known teratogenic medication. Singleton births only.
Ishikawa, 2024	nested case control	Exposure were identified according to the WHO-ATC or alternate entries in the administrative claims database from JMDC Inc. (Tokyo, Japan), which contains pharmacy claims received from the insurers.	Birth outcomes was unavailable in the Japanese claims database. Pregnancies and birth outcomes were estimated using two methods: the first one was for those whose pregnancy-and birth outcome-related entries were available, and their pregnancies and birth outcomes were estimated using these entries.	Exclusion of women with recurrent pregnancy loss, antiphospholipid syndrome, medications at risk of miscarriage. Adjusted for indications (schizophrenia, manic episodes, bipolar, depressive or anxiety disorder), uterine diseases (endometriosis, uterus and cervix malformations, ...), maternal comorbidities (polycystic ovarian, diabetes, obesity, or thyroid disorders), alcohol/tobacco dependence,...
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)	When sufficient data: adjustment was made for year of birth, maternal age, parity, smoking in early pregnancy, and BMI.
McKenna, 2005	prospective cohort	Exposure declared by women during exposure and data were achieved by sending each general practitioner a detailed questionnaire with questions regarding drug history.	This was achieved by sending each general practitioner a detailed questionnaire with questions regarding pregnancy outcome. Once the questionnaire was completed, permission was requested to receive a report from the physician primarily caring for the infant.	No adjustment/match for this exposed group.
Newport, 2007	prospective cohort	Maternal interview at monthly intervals during pregnancy (at which time maternal use of prescription and nonprescription medications was documented). Pregnant women treated with antipsychotics during pregnancy proximate to delivery	Obstetrical outcome data were ascertained from maternal reports and reviews of medical records.	The association of obstetrical outcome with the following covariates was analyzed: participant demographic characteristics (i.e., race, marital status, principal psychiatric diagnosis) and concomitant pharmacotherapy with other classes of psychotropic agents (i.e., antidepressants, sedative-hypnotics, antiepileptic drugs).
Ozturk, 2016	retrospective cohort	At the first contact, a detailed patient history form was used to record the following information: maternal demographic data and obstetric history, consanguineous marriage, smoking and alcohol consumption, X-ray and all drug exposures (dose, duration and timing in pregnancy).	After counseling about the risk of drug exposure, the women and their babies were followed up during a 2-year period. Each newborn baby was checked at birth for signs of problems or complications.	None
Park, 2018	retrospective cohort (claims database)	The Medicaid Analytic eXtract, nationwide claims database that contains information on pharmacy dispensing records.	The Medicaid Analytic eXtract, nationwide claims database that contains information on hospitalizations, and outpatient visits.	Propensity-score stratification. Potential confounders or proxies studied: demographic data, psychiatric diagnoses, comorbidity, other medication use, history of gestational diabetes, and the duration of antipsychotic treatment, the number of different generic drugs received and the number of emergency department visits during the 3 months before the last menstrual period.
Peng, 2013	prospective cohort	A detailed questionnaire completed by all enrolled pregnant women prior to delivery. Once the questionnaire was completed, permission was requested to receive a report from the physician and obstetrician.	The Bayley-III was administered by a psychologist who specialized in this scale and assessed neurodevelopment of children for the hospital. The psychologist was not a part of research team and was blinded during all neurobehavioral development assessments	Each participant with schizophrenia was matched with a control for maternal age (plus or minus 1 year) and equivalent education level (determined by graduation diploma).
Raguideau, 2017	retrospective cohort (claims database)	The French national health insurance database (DCIR) containing all individualized and anonymous health care claims reimbursed by French National Health Insurance.	The French hospital discharge database (PMSI) covering the entire French population.	Malfo as a whole: Adjustment on the year of the end of pregnancy, maternal age, folic acid supplementation and a proxy of social status (for OR calculated with at least 5 cases in each group)
Sadowski, 2013	prospective cohort	Telephone interviews of mothers.	Information provided by the mothers and data obtained from physicians (request of a report from the child’s physician, which included hospital birth records, postnatal assessments and information on congenital malformations and the child’s health)	No adjustment/match for this exposed group. Exclusion of fertility-assisted pregnancies, twin/triplet pregnancies, pregnancies exposed to teratogenic medications unrelated to their psychiatric disorder treatment, such as acutane, or who abused substances (eg, alcohol, marijuana, cocaine, heroin, etc).
Sorensen, 2015	population based cohort retrospective	Any prescription recorded in the Danish National Prescription Register.	Any spontaneous abortion (< 22 weeks) or stillbirth recorded in the Danish National Hospital Register and the Danish Medical Birth Register respectively.	Adjusted for maternal age divided into three groups and history of drug abuse.
Straub, 2022	retrospective cohort (claims database)	The nationwide Medicaid Analytic eXtract (MAX) and the IBM Health MarketScan Research Database (MarketScan). Both sources included outpatient medication dispensings.	The nationwide Medicaid Analytic eXtract (MAX) and the IBM Health MarketScan Research Database (MarketScan). Both sources included diagnosis and procedure claims during hospitalizations, outpatient and emergency department visits.	Adjusted for maternal age, race and ethnicity, treatment indications, smoking, alcohol dependance, Substance use disorder, Proxy for severity of Mental Health-related illness, Other prescription medication exposure, pregestational diabetes and hypertension, hyperemesis, Obstetric Comorbidity Index, County-level socioeconomic status measures.
Vigod, 2015	retrospective cohort (claims database)	Ontario Drug Benefit (ODB) database	Maternal medical outcomes identified in Canadian Institutes of Health Information Discharge Abstract Database (CIHI-DAD). Main perinatal outcomes identified usingICES’ MOMBABY datafile.	None. High dimensional propensity score (HDPS) matched control group for antipsychotics as a whole. Adjusted RR only provided on a graph (cannot be extracted accurately).
Viguera, 2023	prospective cohort	Participants were interviewed by trained research staff via phone at three points across pregnancy: enrollment (any time during pregnancy), 7 months gestation, and 3 months postpartum. Interview collected notably information regarding pharmacotherapy before, during, and after pregnancy.	Outcome data are obtained through maternal interview and systematic review of labor and delivery and pediatric medical records. Information regarding primary and secondary outcomes is abstracted from medical records by a trained research coordinator and a senior study physician-investigator	No adjustment.
Wang - HK cohort, 2021	retrospective cohort (claims database)	Prescriptions of any antipsychotic listed in Chapter 4.2.1 of the British National Formulary (BNF) were extracted from the prescribing and dispensing records.	The Hong Kong Clinical Data Analysis and Reporting System (CDARS) which consists of anonymized electronic health records from HK hospitals and contains 43 hospitals and institutions, 49 specialist outpatient clinics, and 73 general outpatient clinics which is accessible to all HK residents.	Maternal age, calendar year, maternal underlying medical conditions (epilepsy, hypertension and SMI [e.g. schizophrenia, bipolar disorder and depression]), duration of antipsychotics, other psychotropics use, household income status. Primiparous pregnancies only. Exclusion of women with a diagnosis of pre-pregnancy diabetes (Type 1 and Type 2).
Wang - UK cohort, 2021	retrospective cohort (claims database)	Prescriptions of any antipsychotic listed in Chapter 4.2.1 of the British National Formulary (BNF) were extracted from the prescribing and dispensing records.	The UK The Health Improvement Network (THIN) which consists of anonymized electronic health records from UK primary care. THIN covers medical records of patients registered at 744 participating practices.	Maternal age, calendar year, maternal underlying medical conditions (epilepsy, hypertension and SMI [e.g. schizophrenia, bipolar disorder and depression]), duration of antipsychotics, other psychotropics use, Body Mass Index, smoking and alcohol status and family history of diabetes. Primiparous pregnancies only. Exclusion of women with a diagnosis of pre-pregnancy diabetes (Type 1 and Type 2).
Wurtz, 2017	population based cohort retrospective	Danish Register of Medicinal Product Statistics.	Use of primary health care system in childhood: contacts to the general practitioner (GP) were used as a proxy for the overall health of the children	Sex and birth date of the child, maternal age, parity, cohabitation status, income, education, smoking status, diagnosis of substance abuse, severe psychiatric disorder, depression and epilepsy as well as the use of antiepileptic drugs, antidepressants, benzodiazepines and insulin.

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