Observational Study of Vonoprazan Exposure During Pregnancy
This study is looking at the safety of a medication called vonoprazan when taken by pregnant women. Vonoprazan is used to treat conditions like heartburn and acid reflux (erosive esophagitis, symptomatic non-erosive gastroesophageal reflux disease), and H. pylori infection. Researchers want to compare the health of mothers and their babies who took vonoprazan during pregnancy with those who didn't take vonoprazan but had similar conditions. The main goal is to see how many babies have major birth defects (major congenital malformations) in both groups. You can join if you are a woman between 15 and 50 years old, are currently or recently pregnant, and agree to share your health information. The study aims to include 728 participants, but its current status is unclear.
- Study design
- This is an observational study, meaning researchers will watch and collect information from participants rather than giving them a specific treatment. It aims to enroll 728 women.
- What's involved
- You would need to consent to participate and authorize your healthcare provider(s) to share your health data with the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track major birth defects from the date of conception until pregnancy outcome for fetal losses, or for 12 months after birth for live births.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of Participants with Major Congenital Malformations (MCMs)Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births