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临床试验/NCT04617964
NCT04617964已完成不适用

Intra and Interoperator Reproducibility of the Measurement of the Right Portal Vein Diameter at the Third Trimester Scan

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年3月8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
69
试验地点
1
主要终点
Measurement of the right portal vein diameter

研究概览

简要总结

Although routine ultrasound is offered during the third trimester of pregnancy, less than a quarter of newborns with intrauterine growth retardation (IUGR) are suspected antenatally.

The measurement of the right portal vein (RPV) diameter on the transverse abdominal view at the 32 weeks' scan may be a new a tool for detecting small-for-gestational-age (SGA) at birth. The irregular and collapsed aspect of the right portal vein (RPV) on the third trimester ultrasound could be used for identifying hypoxemic and growth-restricted fetuses.

However, to our knowledge, the only interoperator reproducibility study of this measurement was performed using the same stored images or datasets without performing a new examination.

The main objective of this study is to assess the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound.

The secondary objective is to quantify the interoperator reproducibility of the assessment of the aspect, normal or collapsed, of the right portal vein, using an evaluation grid.

Two referees will perform four successive measurements of the diameter of the right portal vein (RPV) during the same ultrasound examination at the third trimester. Each operator will qualify the appearance of the right portal vein as normal or collapsed using an evaluation grid, and will independently performe a series of two measurements using the same method.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women carrying a pregnancy from 30 weeks to 33 weeks either normal or with IUGR,
  • Patient without guardianship or curatorship or subordination,
  • Patient benefiting from a Social Security scheme

排除标准

  • Presence of a fetal malformation,
  • Multiple pregnancy,
  • Premature rupture of membranes,
  • History of bariatric surgery,
  • Body mass index (BMI)> 30 kg / m2,
  • Patient benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.

结局指标

主要结局

Measurement of the right portal vein diameter

时间窗: Through study completion, an average of 1 year

Intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound

次要结局

  • Aspect of the right portal vein diameter(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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