A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vonoprazan.
- Who it may be relevant to
- Registry conditions: Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection. Basic parameters: 15 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Overview
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.
Interventions
- Drug Vonoprazan
Oral tablet.
Primary outcome measures
- Number of Participants with Major Congenital Malformations (MCMs) [Time frame: Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births]
Secondary outcome measures (8)
- Number of Participants with Minor Congenital Malformations [Time frame: DOC to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births]
- Number of Participants who Experience Spontaneous Abortion (SAB) [Time frame: DOC to 19 gestational weeks]
- Number of Participants who Experience Stillbirth [Time frame: 20 gestational weeks to pregnancy outcome (approximately 40 weeks)]
- Number of Participants who Experience Elective Termination [Time frame: DOC to pregnancy outcome (approximately 40 weeks)]
- Number of Participants who Experience Preterm Birth [Time frame: DOC to 36 gestational weeks]
- Number of Participants who are Small for Gestational Age (SGA) [Time frame: At delivery of live birth (approximately 40 weeks)]
- Number of Participants who Experience Postnatal Growth Deficiency [Time frame: 4 Months and 12 Months from Birth]
- Number of Participants who Experience Infant Developmental Delay [Time frame: 4 Months and 12 Months from Birth]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- PPD — Wilmington
Identifiers
NCT: NCT06660342 · VONO-402