Aripiprazole

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Bellet, 2015	prospective cohort	Interview of mother/clinician using structured questionnaires at initial telephone contact and after birth.	Data ascertainment was performed using standardised questions at initial telephone contact and structured questionnaires after birth.	Unexposed patients were matched for age (± 2 years) and gestational age at first call (± 2 weeks). According to the available data, none of them had pre-existing diabetes. Exclusion of co-exposure to teratogens during embryogenesis. Exclusion of multiple births for growth restriction.
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.
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.
Freeman, 2021	prospective cohort	Participants are prospectively interviewed across pregnancy and the early postpartum period by telephone, at enrollment, at 7 months’ gestation, and 12 weeks after delivery.	Data collected from interviews and medical records (from pediatrics and relevant specialists). If a major malformation is suspected, the records are redacted and sent to a dysmorphologist for final blind adjudication. Medical records were obtained and reviewed for 81.3% of the participants.	Univaried. Maternal body mass index (BMI), having a college education, use of prenatal vitamins, marital status, first trimester use of cigarettes, use of anticonvulsants, and diagnosis of depression met the confounder criteria.
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 for this exposed group.
Habermann (Control unexposed, disease free), 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 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,...
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.
Paulus, 2013	prospective cohort	Teratology Information Service (TIS) was contacted by physicians and patients after exposure to aripiprazole in the first trimester.	Not specified	None
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	Malformations 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.	No adjustment for this exposed group.
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.
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).

master protocol