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临床试验/NCT04311749
NCT04311749已完成不适用

The Role of Expanded Panel Non-Invasive Prenatal Testing in Identifying Rare Autosomal Trisomies in Pregnancies With Placentally-Mediated Complications

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Composite adverse pregnancy outcome

研究概览

简要总结

This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia.

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of early onset (< 34 weeks) severe fetal growth restriction, defined as estimated fetal weight less than 10th percentile with abnormal umbilical artery Dopplers OR estimated fetal weight less than 5th percentile alone OR biometric size at least 14 days behind expected dates

排除标准

  • Maternal age < 18 years
  • Multifetal gestation
  • Chronic hypertension require use of pharmacotherapy
  • Tobacco or drug use
  • Major congenital malformations

结局指标

主要结局

Composite adverse pregnancy outcome

时间窗: Through study completion, an average of 2 years

次要结局

  • Preterm birth < 34 weeks(Through study completion, an average of 2 years)
  • Neonatal intensive care unit admission(Through study completion, an average of 2 years)
  • Intrauterine fetal demise(Through study completion, an average of 2 years)
  • Neonatal demise(Through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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