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Frequently Asked Questions
9 questions-
No significant increase was found. In the matched analysis, the composite obstetric outcome occurred in 8.3% of patients receiving second-generation long-acting injectable antipsychotics and 8.7% of patients receiving corresponding oral antipsychotics, with no statistically or clinically significant difference between groups (OR 0.95; 95% CI, 0.761.18; P=.612). The composite outcome included gestational diabetes, preeclampsia, eclampsia, and newly diagnosed hypertensive disorders.
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The study compared a composite of gestational diabetes, preeclampsia, eclampsia, and newly diagnosed hypertensive disorders in pregnant adults treated with second-generation antipsychotics. The investigators also examined each of these outcomes individually and assessed the odds of cesarean section. No statistically or clinically significant differences were observed between long-acting injectable and oral formulations for the composite outcome or its individual components.
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No. Cesarean section rates were not significantly different between the matched long-acting injectable and oral second-generation antipsychotic cohorts, with an odds ratio of 1.09 (95% CI, 0.831.43; P=.537).
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The initial database search identified 31,376 pregnant patients in the oral antipsychotic cohort and 2,082 in the long-acting injectable cohort. After 1:1 propensity score matching, the final analysis included 2 matched cohorts of 2,025 patients each.
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The researchers used 1:1 propensity score matching across 26 features to balance the groups before comparing outcomes. Matching variables included age, race, social determinants of health, psychiatric and medical comorbidities, and concomitant psychotropic medications such as lithium, valproic acid derivatives, antidepressants, and sedative-hypnotics. After matching, all covariates had standardized mean differences below 0.1, with a maximum standardized difference of 0.095, indicating good measured balance.
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The study included second-generation formulations of aripiprazole, risperidone, paliperidone, and olanzapine. Patients were grouped by exposure to either a long-acting injectable version of these agents or the corresponding oral antipsychotic during the defined pregnancy-related exposure window.
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No. This study did not assess congenital malformations or spontaneous abortion, so its findings should not be used to infer teratogenic risk or miscarriage risk with long-acting injectable antipsychotics. The authors state that spontaneous abortion was not included because it is more likely to occur in the first trimester, and congenital malformations could not be evaluated because of limitations in maternal-neonatal chart linkage within the database.
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The study found similar obstetric outcomes with second-generation long-acting injectable and oral antipsychotics, which suggests that formulation choice can be guided by clinical factors such as adherence and relapse prevention rather than an observed difference in gestational diabetes or hypertensive obstetric complications. The authors conclude that long-acting injectable antipsychotics may be safe to continue or initiate when considering obstetric complications, particularly when the risks of untreated psychiatric illness outweigh medication-related adverse effects.
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The main limitations were those typical of retrospective database studies, including incomplete or variable coding and reporting practices. The database did not consistently capture all maternal and neonatal outcomes or relevant confounders such as severity of maternal psychiatric illness, and the investigators could not quantify the duration or extent of individual antipsychotic exposure. The study also did not analyze risks for individual antipsychotic drugs separately, and oral antipsychotic overlap was allowed in the long-acting injectable cohort.