Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 728
- 试验地点
- 2
- 主要终点
- Number of Participants with Major Congenital Malformations (MCMs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Exposed Cohort
Pregnant women who are exposed to vonoprazan during pregnancy.
干预措施: Vonoprazan (Drug)
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.
结局指标
主要结局
Number of Participants with Major Congenital Malformations (MCMs)
时间窗: Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births
次要结局
- 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)