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Quetiapine in a Low Dosage During Pregnancy: Neonatal Outcomes in a Retrospective Cohort Study

van Tienoven, S. F. J.; Gossink, F.; Dullemond, R.; van Dillen, J.

2026-01-21 obstetrics and gynecology
10.64898/2026.01.18.26344354 medRxiv
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BackgroundPrescribing pharmaceutical agents during pregnancy requires a balance between maternal therapeutic needs and foetal risks. Quetiapine, an atypical antipsychotic, is prescribed in psychiatric disorders and increasingly used off-label in low-dosages (<200mg daily) for insomnia during pregnancy. This study aimed to investigate the possible relationship between using quetiapine in a low dosage during pregnancy and the neonatal outcome within the first three days after birth. MethodsA retrospective cohort study was conducted at the Radboud University Medical Centre (RadboudUMC), Nijmegen, The Netherlands. Liveborn neonates admitted to the RadboudUMC during the years 2017-2024 whose mothers used at least one dose of quetiapine ([&le;] 200mg daily) during pregnancy were included. Maternal characteristics and neonatal outcomes were analysed using SPSS, dose-dependent outcomes were also assessed. Results30 neonates were included. Of these, 7 (23.3%) were born preterm, 7 (23.3%) were small for gestational age (SGA), 6 (20.0%) were admitted to the neonatal intensive care unit (NICU) and 2 (6.3%) exhibited withdrawal symptoms. Most neonates were admitted to the hospital for 3 days. ConclusionThis study is the first to evaluate neonatal outcome after maternal low dose quetiapine in pregnancy in the Netherlands. We found relatively high rates of preterm birth, SGA and NICU admissions. As this was a single-centre study without a control group and with a small sample size in an academic population, results should be interpreted with caution. We recommend further prospective and multicentre studies including control groups.

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