Methods Study Cohort Using information from the Medical Birth Registry 7 and the National Patient Register 8 in Denmark, we established a nationwide historical cohort of all pregnancies that resulted in a singleton live birth or stillbirth or ended with any abortive outcome in the period from January 1,through March 31, Pregnant women exposed to ondansetron were not at increased risk for still birth with adjusted HR of 0.
Although these results cannot definitively rule out the possibility of adverse effects in association with ondansetron, the results do provide reassurance regarding the use of this agent for nausea and vomiting in pregnancy. Birth Defects Research Part A: The first prescription was filled at a median of 70 gestational days interquartile range, 57—88 days.
CrossRef 63 Gideon Koren. The adjusted prevalence odds ratio for any major birth defect was similar to that in the primary analysis in sensitivity analyses in which the exposure time window was restricted to the period of maximal susceptibility to teratogenic agents gestational weeks 4 to 10 and including birth defects among induced abortions and stillbirths Table 3 Table 3 Sensitivity Analyses of Ondansetron Exposure in Pregnancy and Adverse Fetal Outcomes.
We used information from the National Prescription Registry to identify prescriptions for ondansetron dispensed to women in the cohort. Exposure to ondansetron at any time during pregnancy was not associated with low birth infants or small gestational age at birth. The timing of exposure was defined by the date the prescription was filled.
Bird, Leyla Sahin, Melissa S. Drugs During Pregnancy and Lactation, Ondansetron use in pregnancy was not associated with a significantly increased risk of major adverse fetal outcomes. In Denmark, ethics approval and informed consent are not required for registry-based research.
Full Text of Results After exclusions, the study cohort comprisedpregnancies. Full Text of Methods See related Challenge and other articles in the series. Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining your privacy and will not share your personal information without your express consent. Retrieved from " http: Didn't get the message?
Close Dialog Join the membership for readers Get monthly access to books, audiobooks, documents, and more Read Free for 30 Days. Pharmacoepidemiol Drug Saf ; Pregnant women exposed to ondansetron in the first trimester did not have greater prevalence of major birth defects compared to women not exposed with adjusted OR of 1.
Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects.