Observational Study on the Safety of Vonoprazan Use During Pregnancy and Effects on Mothers and Babies

What this Trial Is About

Researchers are evaluating the safety of vonoprazan exposure during pregnancy by comparing outcomes for pregnant women who take vonoprazan with those who do not but may use other treatments for similar conditions. The study focuses on maternal, fetal, and infant health, particularly monitoring for congenital malformations and various pregnancy outcomes related to erosive esophagitis, heartburn, symptomatic non-erosive gastroesophageal reflux disease, and Helicobacter pylori infection. The study includes two groups pregnant women exposed to vonoprazan and those not exposed but possibly treated with other medications for related conditions. Vonoprazan is given as an oral tablet. Participants are observed from conception through pregnancy outcome, and infants are followed for up to 12 months after birth to assess health and development. Participants will provide consent and authorize their healthcare providers to share relevant data. Researchers will track major and minor congenital malformations, spontaneous abortion, stillbirth, elective termination, preterm birth, small gestational age at delivery, postnatal growth deficiencies, and developmental delays. Follow-up includes monitoring pregnancy outcomes and infant development for up to one year after birth, ensuring comprehensive safety evaluation over time.

A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring