Glasgow-Osment Britney, Wahib Farah, Kassam Shama, Zanin Madeleine, Garcia-Bournissen Facundo
Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Division of Pediatric Clinical Pharmacology, Department of Pediatrics, London Health Research Centre, Victoria Hospital, London, ON, Canada.
Eur J Clin Pharmacol. 2025 Jul 21. doi: 10.1007/s00228-025-03880-0.
Trazodone, a medication primarily used for anxiety and insomnia, is increasingly prescribed during pregnancy despite limited safety data. This systematic review aims to assess the effects of trazodone exposure during pregnancy on fetal outcomes.
A search was conducted using MEDLINE and Embase databases from the year 2000 to present. Studies were limited to those involving human subjects, published in English, and investigating trazodone exposure during pregnancy. Keywords included "pregnan*," "trazodone," "malformation*," and "birth outcomes." Four reviewers independently extracted data from the selected records. Risk of bias was assessed using the Newcastle-Ottawa Scale. Data synthesis involved a qualitative analysis to summarize and interpret the findings, identifying patterns across the studies.
Fourteen studies met the inclusion criteria. The main outcome measures included fetal and pregnancy outcomes such as congenital malformations, developmental outcomes, poor neonatal adaptation syndrome (PNAS), persistent pulmonary hypertension of the newborn (PPHN), congenital heart defects, gestational age, birth weight, stillbirth, preterm birth, spontaneous and therapeutic abortion, and pre-eclampsia.
The review found no consistent evidence linking trazodone use during pregnancy to increased risks of congenital malformations, stillbirths, or low birth weight. However, some studies suggested a possible association with an increased risk of spontaneous and therapeutic abortions. Given the limited and varied data, further research with larger, well-controlled studies are needed to establish the safety profile of trazodone during pregnancy. Overall, clarifying the specific risks and benefits of trazodone use in pregnancy will better guide clinical decision-making and improve maternal-fetal health outcomes.
PROSPERO number: CRD42024503611.
曲唑酮是一种主要用于治疗焦虑和失眠的药物，尽管安全性数据有限，但在孕期的处方量却日益增加。本系统评价旨在评估孕期暴露于曲唑酮对胎儿结局的影响。
使用MEDLINE和Embase数据库对2000年至今的文献进行检索。纳入的研究仅限于涉及人类受试者、以英文发表且调查孕期曲唑酮暴露情况的研究。关键词包括“妊娠*”“曲唑酮”“畸形*”和“出生结局”。四名评审员独立从选定的记录中提取数据。使用纽卡斯尔-渥太华量表评估偏倚风险。数据综合采用定性分析，以总结和解释研究结果，识别各项研究中的模式。
14项研究符合纳入标准。主要结局指标包括胎儿和妊娠结局，如先天性畸形、发育结局、新生儿适应不良综合征（PNAS）、新生儿持续性肺动脉高压（PPHN）、先天性心脏病、孕周、出生体重、死产、早产、自然流产和治疗性流产以及子痫前期。
该评价未发现一致证据表明孕期使用曲唑酮会增加先天性畸形、死产或低出生体重的风险。然而，一些研究表明可能与自然流产和治疗性流产风险增加有关。鉴于数据有限且各不相同，需要开展更大规模、严格对照的进一步研究，以确定曲唑酮在孕期的安全性概况。总体而言，明确孕期使用曲唑酮的具体风险和益处将更好地指导临床决策，改善母婴健康结局。
PROSPERO编号：CRD42024503611。
