Evidence map›Paper›PMID 40632383›Full record

ArticleDigestive diseases and sciences2025

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

Yumiko Hirasawa, Hisashi Tagashira, Anna Ueno, Yuki Tasaka, Mikako Goto, Atsuko Murashima, Hiroshi Yamamoto

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Article in Digestive diseases and sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Yumiko HirasawaDepartment of Pharmacy, NHO Shikoku Medical Center for Children and Adults, Zentuuji-shi, Kagawa, Japan.
Hisashi TagashiraDepartment of Pharmacy, NHO Okayama Medical Center, Okayama, Japan.ORCID http://orcid.org/0009-0008-1106-871X
Anna UenoDepartment of Pharmacy, NHO Fukuyama Medical Center, Hiroshima, Japan.
Yuki TasakaDepartment of Pharmacy, NHO Okayama Medical Center, Okayama, Japan.ORCID http://orcid.org/0009-0002-0018-8210
Mikako GotoThe Japan Drug Information Institute in Pregnancy, National Center for Child Health and Development, Tokyo, Japan. goto-mk@ncchd.go.jp.ORCID http://orcid.org/0000-0001-5569-9275
Atsuko MurashimaDepartment of Rheumatology and Applied Immunology, Saitama Medical University, Saitama, Japan.ORCID http://orcid.org/0000-0002-0569-7172
Hiroshi YamamotoDepartment of Pharmacy, Kinashi Obayashi Hospital, Takamatsu City, Kagawa, Japan.

Funding

Health and Labour Sciences Research Grant from the Ministry of Health, Labour and Welfare of Japan 23KC2002Research Program from the Japan Agency for Medical Research and Development (AMED) JP19mk0101086h0003
6 · The paper itself

Abstract

BACKGROUND AND

objectiveData 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.

methodsWe 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.

resultsMajor 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.

conclusionAlthough 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.

Indexed as

Abnormalities, Drug-InducedBenzamidesGastrointestinal AgentsAdultFemaleHumansInfant, NewbornJapanMorpholinesPregnancyPregnancy OutcomePregnancy Trimester, FirstProspective StudiesRisk AssessmentRisk FactorsBenzamidesGastrointestinal AgentsMorpholinesmosaprideCongenital anomaliesMedication safetyMosapride citrate hydratePregnancy

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.