NCT03755128已完成不适用
A Multicenter, Prospective Observational Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 18
- 主要终点
- Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)
研究概览
简要总结
The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).
详细描述
The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)
时间窗: GA Week 32 through GA Week 37
次要结局
- Percentage of Participants With Live Birth(Up to approximately GA Week 37)
- Number of days of phototherapy required by neonate(Post-Birth through Age 3 Months)
- Number of Simple Transfusions Required by Neonate in the First 3 Months of Life(Post-Birth through Age 3 Months)
- Percentage of Participants at GA Week 24 Without an IUT(Week 24)
- GA at First IUT(Up to approximately GA Week 37)
- Percentage of Neonates Requiring Exchange Transfusions(Post-Birth through Age 3 Months)
- Number of IUTs Required(Up to approximately GA Week 37)
- Percentage of Participants With Fetal Hydrops(Post-Birth through Age 3 Months)
- Percentage of Neonates Requiring Phototherapy(Post-Birth through Age 3 Months)
- Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life(Post-Birth through Age 3 Months)
研究者
研究点 (18)
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