NCT05345561已完成不适用
A Prospective, Natural History Study to Assess the Occurrence of HPA-1a Alloimmunization in Women Identified at Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Rallybio54 个研究点 分布在 7 个国家目标入组 14,390 人开始时间: 2022年3月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14,390
- 试验地点
- 54
- 主要终点
- Number of participants with higher FNAIT risk characterized by race and ethnicity
研究概览
简要总结
A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women.
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
- 是
入选标准
- •Pregnant women (≥ 18 years of age) who have provided informed consent for the study.
排除标准
- •Participants with prior history of FNAIT
研究组 & 干预措施
Pregnant women
Women with higher risk of FNAIT
干预措施: Clinical data collection (Other)
结局指标
主要结局
Number of participants with higher FNAIT risk characterized by race and ethnicity
时间窗: At inclusion
次要结局
- Pregnancy outcomes: incidence of live births, spontaneous abortion, elective abortion, still birth, and premature birth(At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event)
- Frequency of anti-HPA-1a maternal alloimmunization(At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event)
- Occurrence of neonatal thrombocytopenia(At birth or at the time of the pregnancy terminating event)
研究者
研究点 (54)
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