Adverse neonatal outcomes following in utero antipsychotic exposure remain unclear. This systematic review and meta-analysis aimed to investigate associations between in utero first- and second-generation antipsychotic exposure and various neonatal outcomes. The primary outcome was small for gestational age. Secondary outcomes included other birth weight-related measures, prematurity and neonatal outcomes. MEDLINE, EMBASE, CENTRAL, ICTRP, and ClinicalTrials.gov were searched for on 8th July 2023. Two reviewers independently selected studies reporting associations between exposure and neonatal outcomes (all designs were eligible, no language or time restriction) and extracted data. ROBINS-I was used for risk of bias assessment. Meta-analyses were performed. Measures of association were odds ratios and mean differences. Thirty-one observational studies were included. Regarding small for gestational age < 10th percentile, meta-analysis was only performed for second-generation antipsychotics and showed no evidence for an association (OR 1.31 [95%CI 0.83; 2.07]; I²=46%; p_het=0.13, n = 4 studies). First-generation antipsychotics were associated with an increased risk of small for gestational age < 3rd percentile (OR 1.37 [95%CI 1.02; 1.83]; I²=60%; p_het=0.04, n = 5) and a lower mean birthweight (MD -135 g [95%CI -203; -66]; I²=53%; p_het=0.07, n = 5). Second-generation antipsychotics were associated with large for gestational age > 97th percentile (OR 1.56 [95%CI 1.31; 1.87]; I²=4%; p_het=0.37, n = 4) and Apgar score < 7 (OR 1.64 [95%CI 1.09; 2.47]; I²=47%; p_het=0.13, n = 4). Both types of antipsychotics were associated with increased risks of preterm birth and neonatal hospitalization. Despite potential confounding in the studies, this systematic review and meta-analysis showed that newborns of mothers using antipsychotics during pregnancy are potentially at risk of adverse neonatal outcomes. Data sources: MEDLINE, EMBASE, CENTRAL, ICTRP, ClinicalTrials.gov. Prospero Registration Number CRD42023401805.

子宫内抗精神病药物暴露后的不良新生儿结局仍不清楚。本系统评价和荟萃分析旨在调查宫内第一代和第二代抗精神病药物暴露与各种新生儿结局之间的关联。主要结局为小于胎龄儿。次要结局包括其他与出生体重相关的测量、早产和新生儿结局。于 2023 年 7 月 8 日检索了 MEDLINE、EMBASE、CENTRAL、ICTRP 和 ClinicalTrials.gov。两位评价员独立筛选报告暴露与新生儿结局之间关联的研究（所有设计均符合条件，无语言或时间限制）并提取资料。ROBINS-I 用于偏倚风险评估。进行荟萃分析。相关性指标为比值比和均数差。纳入 31 项观察性研究。关于小于胎龄儿 < 第 10 个百分位数，仅对第二代抗精神病药物进行了荟萃分析，没有显示存在关联的证据 （OR 1.31 [95%CI 0.83;2.07];I²=46%;p_HET=0.13，n = 4 项研究）。 第一代抗精神病药与小于胎龄儿 < 第 3 个百分位数的风险增加相关 （OR 1.37 [95%CI 1.02;1.83];I²=60%;p_het=0.04，n = 5）和较低的平均出生体重 （MD -135 g [95%CI -203; -66]; I²=53%;p_het=0.07，n = 5）。 第二代抗精神病药与大于胎龄儿 > 第 97 个百分位数 （OR 1.56 [95%CI 1.31;1.87];I²=4%;p_het=0。37，n = 4）和 Apgar 评分 < 7 （OR 1.64 [95%CI 1.09;2.47];I²=47%;p_het=0.13，n = 4）。 两种类型的抗精神病药物都与早产和新生儿住院风险增加有关。尽管研究中可能存在混杂因素，但本系统评价和荟萃分析表明，母亲在怀孕期间使用抗精神病药物的新生儿可能面临不良新生儿结局的风险。数据源：MEDLINE、EMBASE、CENTRAL、ICTRP ClinicalTrials.gov。Prospero 注册号 CRD42023401805。