Peer-reviewed article
Maternal Mosapride Citrate Hydrate Exposure During the First Trimester: Assessing Risks for Congenital Anomalies.
Hirasawa Y, Tagashira H, Ueno A, Tasaka Y, Goto M et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study examined whether a medication called mosapride citrate hydrate, used to treat nausea and stomach problems, increases the risk of birth defects when taken during early pregnancy. Researchers compared 104 babies whose mothers took mosapride in the first trimester with 1,693 babies whose mothers did not take it. The rate of major birth defects was nearly identical in both groups, suggesting the medication does not substantially increase this risk.
Key points
- Major congenital anomalies occurred in 1.92% of infants exposed to mosapride versus 1.89% in the control group
- Relative risk was 1.02 (95% CI 0.24-4.26), showing no statistically significant difference between groups
- No significant differences found in stillbirth, spontaneous abortion, preterm birth, or low birth weight between groups
- Data came from prospective consultations at two Japanese teratology information centers over 29 years
- Authors acknowledge sample size limitations may not exclude small increases in risk
Limitations
The study's sample size for the exposed group (104 infants) may be too small to detect small to moderate increases in rare birth defects. The findings apply only to first-trimester exposure in the Japanese population studied.
Abstract
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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Mosapride citrate hydrate exposure during the first trimester of pregnancy
- Population
- Pregnant women who consulted teratology information centers in Japan between 1988 and 2017; exposed group n=104 infants, control group n=1,693 infants
Key finding
Major congenital anomalies in mosapride group: 2 of 104 infants (1.92%)