Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed Cohort | Pregnant women who are exposed to vonoprazan during pregnancy. |
| |
| Unexposed Cohort | Pregnant women who are not exposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Oral tablet. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study aims to enroll a total of 728 pregnant women in the study population from the United States, with 364 women in each cohort. This sample size will afford the study the ability to detect a 3-fold increase in the prevalence of the primary outcome, MCM, in the exposed cohort with 80% power.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VOQUEZNA Pregnancy Registry | Contact | 1-866-609-1612 | DLVOQUEZNAPregnancyRegistry@ppd.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Recruiting | Wilmington | North Carolina | 28401 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |