Ziprasidone

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
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.
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.
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.

master protocol