The objective of the study was to evaluate the rate of major congenital anomalies after first trimester exposure to ondansetron for nausea and vomiting of pregnancy (NVP). The design is a prospective, comparative, observational cohort study, performed at the Israeli Teratology Information Service between 2010 and 2014. Follow-up was obtained for 195 ondansetron-exposed, 110 metoclopramide-exposed, and 778 pregnancies with non-teratogenic exposure (NTE). The overall rate of major anomalies did not significantly differ between the groups [4/200 = 2.0 % (ondansetron), 1/109 = 0.9 % (metoclopramide), and 13/731 = 1.8 % (NTE)]. All the anomalies in both the ondansetron and metoclopramide groups, and 6/13 anomalies in the NTE group, were cardiac septal defects most of which spontaneously resolved. Both ondansetron (adjHR = 0.29, 95 % CI 0.10−0.80) and metoclopramide (adjHR = 0.27, 95 % CI 0.08−0.86) were associated with lower miscarriage rate compared to NTE. Based on the present study, ondansetron during pregnancy is not associated with an increased risk for overall major anomalies, nor for clinically important cardiac defects. It may be a reasonable alternative for women with severe NVP who do not respond to first line medications.

该研究的目的是评估妊娠头三个月暴露于昂丹司琼导致妊娠恶心和呕吐 (NVP) 后主要先天性异常的发生率。该设计是一项前瞻性、比较性、观察性队列研究，于 2010 年至 2014 年在以色列畸形学信息服务中心进行。对 195 例昂丹司琼暴露、110 例甲氧氯普胺暴露和 778 例非致畸暴露 (NTE) 妊娠进行了随访。 ）。主要异常的总体发生率在各组之间没有显着差异 [4/200 = 2.0 %（昂丹司琼）、1/109 = 0.9 %（甲氧氯普胺）和 13/731 = 1.8 % (NTE)]。昂丹司琼和甲氧氯普胺组的所有异常以及 NTE 组中的 6/13 异常都是心脏间隔缺损，其中大部分是自发解决的。两种昂丹司琼 (adjHR = 0.29, 95 % CI 0.10−0. 80) 和甲氧氯普胺 (adjHR = 0.27, 95 % CI 0.08-0.86) 与较低的流产率相关。根据目前的研究，怀孕期间的昂丹司琼与总体主要异常或临床上重要的心脏缺陷的风险增加无关。对于对一线药物无反应的重度 NVP 女性，这可能是一个合理的选择。