Lurasidone

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Cohen, 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.	Participants were interviewed by trained research staff via phone postpartum to gather delivery and neonatal outcomes. Maternal report was confirmed to 6 months post-partum using a rigorous maternal and pediatric medical record review process by study staff and a senior physician investigator.	Possible confounding assessed individually (one after another): age, body mass index, diagnosis of bipolar disorder or generalized anxiety disorder, education, ethnicity, married, number of hospitalisations, pregnancy planned, parity, use in 1st trimester: alcohol, illicit drug, anticonvulsivant, antidepressant, SSRI, SNRI, stimulant, typical antipsychotic, cigarette,
Kernizan, 2019	retrospective cohort	Not reported.	Not reported.	None.
Kernizan (Controls exposed to LTG), 2024	retrospective cohort	Analyzed clinical data extracted from the electronic medical records. Maternal information collected included bipolar treatment regimens at the first visit, throughout pregnancy, and at delivery and illicit drug use by the mother during pregnancy.	Pertinent neonatal information was collected from a review of neonatal electronic medical records and included gender, delivery type, birth weight, length, head circumference, Apgar Score at 1 and 5 min, presence and type of anatomical malformation, and neonatal intensive care unit (NICU) admission.	None. No difference was observed between groups (no other details).
Kernizan (Controls unexposed, sick), 2024	retrospective cohort	Analyzed clinical data extracted from the electronic medical records. Maternal information collected included bipolar treatment regimens at the first visit, throughout pregnancy, and at delivery and illicit drug use by the mother during pregnancy.	Pertinent neonatal information was collected from a review of neonatal electronic medical records and included gender, delivery type, birth weight, length, head circumference, Apgar Score at 1 and 5 min, presence and type of anatomical malformation, and neonatal intensive care unit (NICU) admission.	None. No difference was observed between groups (no other details).

master protocol