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To examine the potential associations with the timing of antipsychotic use, we further separated the pregnancy period into trimesters: first trimester days after the LMPsecond trimester days after the LMP and third trimester days after the LMP to delivery. Besides using a propensity score PS approach to address measured confounding from pregnancy and maternal characteristics, we also applied a sibling-matched analysis to for unmeasured genetic and environmental factors that could be shared among the siblings; negative control analyses further supported the study conclusions.

The Table summarizes the patient characteristics. Conclusions and Relevance In this cohort study, the findings did not suggest that prenatal antipsychotics exposure increased the risk of ADHD, ASD, or small for gestational age.


from analysis comparing gestational-exposed to antipsychotics with gestational non-exposed. As a result, this linkage is highly accurate. There was no statistically ificant difference between gestational vs past maternal exposure in the risk of ADHD wHR, 0.

The gestational age at birth was calculated and recorded by relevant health care professionals based on ultrasonography that was performed at the first obstetric visit and directly accessed from CDARS.

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Similarly, gestationally exposed individuals were compared with those with past exposure to assess whether there was a difference in the risk of study outcomes. Our findings are consistent with those of Petersen et al 10who focused on general developmental disorders in children and had a limited follow-up time. These suggest that maternal psychiatric disorders are associated with a higher risk of neurodevelopmental disorders rather than gestational exposure to antipsychotic drugs. De, Setting, and Participants This population-based cohort study included children born between January and January with follow-up to December who were identified by the Hong Kong Clinical Data Analysis and Reporting System.

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We compared those with a past exposure with those never exposed. Published online August 16, Maternal psychiatric disorders were associated with a ificantly increased risk of ADHD and ASD, but not with preterm birth or small for gestational age in neonates. The weighted hazard ratio wHR was 1. Moreover, a systematic review that included studies published up to reported an increased risk of preterm birth and small for gestational age 12 ; however, most of the included studies had limited adjustment for confounders.

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Moreover, gestational exposure to antipsychotic drugs is unlikely to pose a ificant risk of preterm birth and small for gestational age in children. Importance The risk of birth and neurodevelopmental complications with prenatal exposure dating antipsychotics is unclear. Interpretations of the subgroup analyses and sensitivity analyses are shown in eAppendix 2 and eTables 6 and 7 in the Supplement.

A sibling-matched analysis was conducted to control for shared genetic and social confounding factors at the family level. Furthermore, a later study found contradictory ; therefore, it generated further uncertainties as to these associations. Informed consent was waived as this study Yonkers not have patient contact and used anonymized data. When the analysis was restricted to mothers online had never used antipsychotics, the risk of neurodevelopmental disorders was higher in mothers with psychiatric disorders ADHD: wHR, 2.

The PS, the probability of receiving treatment that is conditional on the observed characteristics at baseline, can be applied to for confounding effects in pharmacoepidemiology studies. We conducted several additional analyses to evaluate the effect of confounding by indication. studies were limited by including relatively low s of women who were prescribed antipsychotics during pregnancy, inadequate duration of follow-up, inadequate mother-child record linkage, and poorly specified exposure time in the study de.

A UK study with 2 to 3 years of follow-up found no association between antipsychotic use in pregnancy and the risk the neurodevelopmental disorders in infants. For ASD, all children had at least 3 years of follow-up by the end of the study period December 31, For ADHD, we limited inclusion to deliveries between January 1,and December 31,to have at least 6 years of follow-up by the end of the study period December 31, We defined a valid mother-child linkage as an exact match of mother and child patient identification s and delivery date, which are linked permanently and immediately after delivery.

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A robust standard error was applied to adjust for data clustering. Eighteen of exposed Most exposed women had long-term antipsychotic treatment throughout the entire pregnancy period; the evidence did not support any association between gestational antipsychotic exposure at different trimesters and the risk of study outcomes Figure 4 ; eTable 3 in the Supplement. Based on maternal antipsychotic use at different risk periods, we further classified the children into 3 groups: 1 those whose mothers did not use antipsychotics during pregnancy gestationally nonexposedwithin whom we further specified a subgroup as gestationally nonexposed with psychiatric disorders coded using the International Classification of Diseases, Ninth Revision, Clinical Modification [ ICDCM ] codes ; 2 those with mothers who used antipsychotics before pregnancy but whose mothers discontinued receipt of treatment when pregnant past exposure ; and 3 those who never used antipsychotics either before or during pregnancy never exposedwithin which subgroup analyses further classified into 1 never exposed with psychiatric disorders and 2 never exposed without psychiatric disorders eFigure 2 in the Supplement.

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Propensity score PS fine stratification weighting was used to address the differences in baseline covariates. There is no evidence to support the risk of preterm birth wOR, 1. In the primary analysis, there was a small increased risk of preterm birth, but additional analyses comparing gestationally exposed individuals with those with past exposure and comparing gestationally exposed with gestationally nonexposed siblings did not support an increased risk. Children were considered to have been exposed prenatally if their mother received any antipsychotics during the pregnancy period gestationally exposed.

Following stratification, weights for exposure and reference patients in all strata were subsequently calculated based on the total of patients within each stratum, while strata with no exposure or reference patients were dropped out before weight calculation.

Although our estimates had relatively wide intervals, given the benefits of antipsychotic treatment, our findings do not support a recommendation for women to discontinue receipt of their regular antipsychotic treatment during pregnancy. To assess the role of maternal psychiatric disorder, we restricted comparison cohorts to those never exposed. If maternal psychiatric disorder is associated with risk of outcomes in children, this introduces the possibility of confounding by indication.

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Different outcomes of interest in comparing those gestationally exposed to antipsychotics with gestationally nonexposed individuals in different exposed times. SAS, version 9.

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All comparison group are found in Figure 2 and Figure 3 as well as eTable 4 in the Supplement. Furthermore, the risk was the same for unexposed siblings and exposed siblings. An increased risk of outcomes in the children of mothers among those with a past exposure indicates confounding by indication, as the infant was not exposed to antipsychotics. However, among pregnant women who were never exposed to antipsychotics, children born to mothers with psychiatric disorders had a higher risk of neurodevelopmental disorders ASD and ADHDbut not negative birth outcomes preterm birth and small for gestational age compared with those with mothers without psychiatric disorders.

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Overall, children 0. Standardized mean differences before and after PS weighting in different covariates. Only inconsonant sibling pairs for maternal antipsychotic use and study outcomes could contribute to the estimates.

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If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. Given the benefits of treating psychosis during pregnancy, our findings do not support a recommendation for women to discontinue receipt of their regular antipsychotic treatment during pregnancy. suggested no difference in the risk of all outcomes when comparing gestationally exposed vs past exposure.

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While 0. Antipsychotics, including first-generation and second-generation antipsychotics, are increasingly prescribed for pregnant women 12 ; however, the safety of antipsychotic use during pregnancy remains unclear. Not all submitted comments are published.

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We defined any time before the LMP as the prepregnancy period. Although unlikely to be causal, studies showed some association between prenatal antidepressants or lithium treatment exposure and the risk of our study outcomes. Our are also consistent with another Canadian population-based study 13 that found no evidence to support an increased risk of preterm birth or small for gestational age in children with antipsychotic exposure during pregnancy. The information will be posted with your response. Objective To evaluate the association between prenatal antipsychotics exposure and the risk of birth and neurodevelopmental problems.


Covariates were identified for confounding adjustment. However, considering the analyses of the negative control Figure 2 ; eTable 4 in the Supplementsibling-matched Figure 3 ; eTable 5 in the Supplementand several sensitivity and subgroup analyses eTables 6 and 7 in the Supplementour study do not suggest an increased risk of ADHD, ASD, preterm birth, and small for gestational age that is associated with prenatal exposure to antipsychotics.

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All variables listed in the covariates section were included in the PS model. Prescriptions of any antipsychotic listed in chapter 4. Additional analyses included gestationally exposed individuals vs those with past exposure and a sibling-matched analysis to evaluate the effect of confounding by indication. Please see our commenting policy for details. Thus, an observational study is a practical approach to investigate these associations.

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Additional analyses showed no association when comparing gestationally exposed individuals with those with past exposure ADHD: wHR, 0. Primary analyses compared gestationally exposed and gestationally nonexposed individuals with propensity score fine stratification. Subgroup analyses and sensitivity analyses were conducted to test the validity of the initial analyses eAppendix 1 in the Supplement.

Meaning The findings of this study suggest that there is no association between prenatal exposure to antipsychotics and ADHD, ASD, preterm birth, and small for gestational age; however, underlying maternal psychiatric disorders may be associated with the risk of ADHD and ASD in children.

The study cohort included all pregnant episodes of females aged 15 to 50 years old who delivered a live birth between January 1,and December 31, Preterm birth and small for gestational age were identified and recorded at the delivery date. To focus on the population of women who were most clearly at risk for treatment with antipsychotics during pregnancy, we also compared gestationally exposed individuals with gestationally nonexposed individuals with psychiatric disorders.

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Additional analyses were conducted to evaluate the effect of confounding by indication. There are limited studies about the association between the use of antipsychotics in pregnancy and the risk of neurodevelopmental disorders in children.

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The pregnancy period was defined as the period between the LMP and delivery date eFigure 1 in the Supplement. From the primary analysis, we can only rule out more than a 1. Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.