Erosive Esophagitis, Heartburn, Helicobacter Pylori Infection, Symptomatic Non-erosive Gastroesophageal Reflux Disease
Conditions
Keywords
Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection, Pregnant Women, Fetal, Infant
Brief summary
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
DRUGVonoprazan
Oral tablet.
Sponsors
Phathom Pharmaceuticals, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Minor Congenital Malformations | 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) | DOC to 19 gestational weeks |
| Number of Participants who Experience Stillbirth | 20 gestational weeks to pregnancy outcome (approximately 40 weeks) |
| Number of Participants who Experience Elective Termination | DOC to pregnancy outcome (approximately 40 weeks) |
| Number of Participants who Experience Preterm Birth | DOC to 36 gestational weeks |
| Number of Participants who are Small for Gestational Age (SGA) | At delivery of live birth (approximately 40 weeks) |
| Number of Participants who Experience Postnatal Growth Deficiency | 4 Months and 12 Months from Birth |
| Number of Participants who Experience Infant Developmental Delay | 4 Months and 12 Months from Birth |
Countries
United States
Contacts
CONTACTVOQUEZNA Pregnancy Registry
Outcome results
None listed