Examining the safety of vonoprazan in pregnant women and their babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety of vonoprazan exposure in pregnant women by comparing maternal, fetal, and infant outcomes between those who have taken vonoprazan and those who have not. The study will include women aged 15 to 50 who are currently or recently pregnant, with one group having been exposed to vonoprazan and another serving as a comparison cohort. Data will be collected from healthcare providers to evaluate the effects of the medication on both mothers and their offspring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women 15 to 50 years of age.
* Currently or recently pregnant.
* Consent to participate.
* Authorization for her health care provider(s) (HCP\[s\]) to provide data to the registry.
* Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy.
* Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed.

Exclusion Criteria:

* Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
* Exposure to known tetratogens and/or investigational medications during pregnancy.
* Lost to follow-up.

Where it's running

• Ppd
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Study coordinator: VOQUEZNA Pregnancy Registry
• Email: DLVOQUEZNAPregnancyRegistry@ppd.com
• Phone: 1-866-609-1612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.