Background and Hypothesis Pregnant women with persistent schizophrenia and related disorders may require ongoing antipsychotic treatment, including clozapine. However, the potential risks of using clozapine during pregnancy and the postnatal period remain uncertain. Study Design We conducted a nested case-control study using the National Register of Antipsychotic Medication in Pregnancy (NRAMP) database. Our study assessed pregnancy outcomes among Australian women diagnosed with schizophrenia spectrum disorder and treated with clozapine (n = 14) during the first trimester. These women were compared to 2 subgroups: those treated with quetiapine (n = 53) and those not taking any medication (n = 24) during pregnancy. Study Results We observed higher rates of miscarriage in the clozapine group compared to the quetiapine and drug-free groups. The clozapine group had a higher early pregnancy body mass index but lower overall pregnancy weight gain than the other groups. The prevalence of gestational diabetes was significantly higher in the clozapine group. The percentage of vaginal delivery was higher in the clozapine group than in the other 2 groups. Neonatal outcomes such as gestational age, and Apgar scores were similar across groups. The birth weight was lower in the clozapine group compared to the other 2 groups. Conclusions This study suggests that pregnant women taking clozapine and their babies have greater adverse outcomes compared to other groups. Clozapine appears to be associated with a greater risk of miscarriages, maternal gestational diabetes, and lower birth weight. However, the gestational age, Apgar scores, and admission to NICU/SCN were comparable between all groups.

中文翻译：

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妊娠期氯氮平的安全性：临床研究


背景和假设患有持续性精神分裂症和相关疾病的孕妇可能需要持续的抗精神病药物治疗，包括氯氮平。然而，怀孕期间和产后使用氯氮平的潜在风险仍不确定。研究设计 我们利用国家妊娠期抗精神病药物登记册 (NRAMP) 数据库进行了一项巢式病例对照研究。我们的研究评估了被诊断患有精神分裂症谱系障碍并在妊娠前三个月接受氯氮平治疗的澳大利亚女性 (n = 14) 的妊娠结局。将这些女性与 2 个亚组进行比较：接受喹硫平治疗的女性 (n = 53) 和怀孕期间未服用任何药物的女性 (n = 24)。研究结果 我们观察到，与喹硫平组和未用药组相比，氯氮平组的流产率较高。与其他组相比，氯氮平组的早期妊娠体重指数较高，但总体妊娠体重增加较低。氯氮平组妊娠期糖尿病的患病率显着较高。氯氮平组的阴道分娩百分比高于其他两组。各组的新生儿结局（例如胎龄和阿普加评分）相似。与其他两组相比，氯氮平组的出生体重较低。结论 这项研究表明，与其他群体相比，服用氯氮平的孕妇及其婴儿会出现更大的不良后果。氯氮平似乎与流产、孕产妇妊娠糖尿病和低出生体重的风险增加有关。然而，所有组之间的胎龄、Apgar 评分和入住 NICU/SCN 的情况相当。