Maternal Mosapride Citrate Hydrate Exposure During the First Trimester: Assessing Risks for Congenital Anomalies.

Background and objective: Data on mosapride citrate hydrate (mosapride) safety during pregnancy are limited. This study aimed to evaluate the effects of maternal mosapride exposure on pregnancy and infant outcomes.

Methods: We conducted a prospective cohort study using data from two teratology information centers in Japan. Pregnant women who consulted these centers between April 1988 and December 2017 were included. The incidence of major congenital anomalies was compared between women exposed to mosapride during the first trimester and a control group. Multivariate logistic regression analysis was performed to assess potential risks.

Results: Major congenital anomalies were observed in 2 of 104 infants (1.92%) in the mosapride group and 32 of 1693 infants (1.89%) in the control group. The relative risk was 1.02 (95% confidence interval [CI] 0.24-4.26), indicating no statistically significant difference. Other pregnancy outcomes, including stillbirth, spontaneous abortion, preterm birth, and low birth weight, also showed no significant differences between groups.

Conclusion: Although our study may not exclude small increases in risk due to sample size limitations, the findings suggest that mosapride exposure during early pregnancy is not associated with a substantial increase in the risk of major congenital anomalies. These findings may help alleviate concerns related to mosapride use during pregnancy.