NCT03664648进行中（未招募）不适用
HEPLISAV-B Pregnancy Registry: An Observational Study on the Safety of HEPLISAV-B Exposure in Pregnant Women and Their Offspring
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of Major Congenital Malformations in Live-Born Infants.
研究概览
简要总结
Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years and older
- •HEPLISAV-B exposure within 28 days prior to conception or at any time during pregnancy
排除标准
- •Less than 18 years of age
- •HEPLISAV-B exposure greater than 28 days prior to conception
结局指标
主要结局
Rate of Major Congenital Malformations in Live-Born Infants.
时间窗: Live-born infants will be followed to 12 months of age
Rate of Still Births, Pre-Term, or Fetal Loss (Including Spontaneous Abortion) of any Gestational Age
时间窗: Follow-up will end at the time of pregnancy outcome up to 9 months
次要结局
未报告次要终点
研究者
研究点 (1)
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