Ondansetron Use During Pregnancy for Nausea and Vomiting and the Risk of Preterm Birth [34D

Abstract

INTRODUCTION: Nausea and Vomiting of Pregnancy (NVP) is a common condition affecting up to 80% of pregnant women. Risks of adverse pregnancy outcomes associated with anti-nausea medications have not been well studied. As one of the more common drugs administered for treatment of NVP, we investigated ondansetron use and risk of preterm delivery. METHODS: These data represent a secondary analysis of maternal pregnancy and fetal outcome characteristics from the prospective Proteomic Assessment of Preterm Risk (PAPR) study (2011-2013), where 5,501 pregnant women were enrolled between 17 and 28 weeks of gestation at 11 sites in the United States. Only women who consented to remain in the PAPR repository (n=3,563) were considered eligible and used in this analysis. Potential associations between exposed and unexposed women were investigated statistically by the use of Chi square and multivariate logistic regression. RESULTS: NVP was reported by 814 (23%) women consenting to remain in the repository. In these women ondansetron exposure prior to 290/7 weeks gestation occurred in 534 (66%) who were eligible for analysis. Women taking ondansetron experienced a PTB rate of 14.6% compared to 14.1% for those who did not (unadjusted OR 1.0 95% CI 0.1-1.4). CONCLUSION: The results of this study suggest that exposure to ondansetron was not associated with increased risk of PTB. However, the sample size in this study is relatively small and future studies should be performed in order to further investigate these findings.