Study | Country Study period Study design |
Data source | Exposure definition | Non-exposure definition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
---|---|---|---|---|---|---|---|---|
Cohen 2023 |
USA 2008 - 2021 prospective cohort |
The National Pregnancy Registry for Psychiatric Medications, USA. | Pregnant women with first trimester (0 <= 13 weeks) use of Lurasidone. |
unexposed, sick
Pregnant women unexposed tp Second-generation antipsychotics (SGAs) during the entire pregnancy. |
1st trimester | 134 / 886 | Univariate adjustments: choice to reporte results adjusted for alcohol use in 1st trimester. | |
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. | ||||||||
Kernizan 2019 |
USA 2014 - 2017 retrospective cohort |
Retrospective cohort of patients referred to Maternal Fetal Care Center, St Louis, Missouri. | Pregnant women exposed to Lurasidone during pregnancy. |
unexposed, sick
Pregnant women not exposed to mood stabilizer during pregnancy. |
during pregnancy (anytime or not specified) | 24 / 140 | For preterm and malfo: Overlapping Kernizan 2019 and 2024: use of Kernizan 2024 because full text publication (Abstract in 2019) => outcomes not reported here. | |
Not reported. | ||||||||
Kernizan (Controls exposed to LTG) 2024 |
USA 2014 - 2017 retrospective cohort |
The Maternal and Fetal Care Center at SSM Health St. Mary's Hospital Center, Missouri, USA. | Pregnant women with a diagnosis of bipolar disorder who were prescribed lurasidone only at some point of their pregnancy. |
exposed to other treatment, sick
Pregnant women with a diagnosis of bipolar disorder who were prescribed lamotrigine only at some point of their pregnancy. |
during pregnancy (anytime or not specified) | 25 / 13 | ||
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. | ||||||||
Kernizan (Controls unexposed, sick) 2024 |
USA 2014 - 2017 retrospective cohort |
The Maternal and Fetal Care Center at SSM Health St. Mary's Hospital Center, Missouri, USA. | Pregnant women with a diagnosis of bipolar disorder who were prescribed lurasidone only at some point of their pregnancy. |
unexposed, sick
Pregnant women with a diagnosis of bipolar disorder who were not prescribed mood stabilizers (lithium, antiepileptics, atypical antipsychotics) at some point of their pregnancy. |
during pregnancy (anytime or not specified) | 25 / 139 | ||
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. |
Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
---|
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;