The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.
Eligibility
Sex
FEMALE
Min age
15 Years
Max age
50 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
PPD
Wilmington
North Carolina
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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