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临床试验/NCT04707456
NCT04707456Unknown不适用

A Comparative Study of Learning Curve Between Two Different Levels of Proficiency for First Trimester Fetal Anomaly Scan Using ISUOG Guidelines

Mahidol University2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2020年6月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
210
试验地点
2
主要终点
Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators

研究概览

简要总结

Ultrasound scans during first trimester are more difficult than routine mid-trimester ultrasound scans. Practice guidelines for first trimester fetal ultrasound scans have been provided by the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) since 2013. Using this guidelines, different levels of proficiency operators might have equal ability to complete first trimester ultrasound scans.

详细描述

Nowadays, high-resolution transabdominal ultrasounds are widely used, and ultrasound scans for fetal structural abnormalities at the first trimester are indeed possible. First trimester ultrasound scans are important and essential for detecting fetal structural anomalies, and they help provide optimized early antenatal management. However, ultrasound scans, during this period, are more difficult than routine mid-trimester ultrasound scans, as fetal organs are small and experienced operators are needed to use the transducer to obtain informative pictures. Practice guidelines for first trimester fetal ultrasound scans have been provided by the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) since 2013. Since then, the percentage of complete scans and the high detection rate of fetal structural abnormalities during first trimester ultrasound scans have been reported. From our perspective, ultrasound operators who have different experiences in mid-trimester ultrasound scanning might have equal ability to complete first trimester ultrasound scans using the ISUOG guidelines. The objective of this study is to compare the rate of completed scans regarding fetal structures at the first trimester ultrasound scan between two different levels of proficiency operators.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy
  • Maternal age ≥ 18 years
  • Gestational age between 11-13 + 6 weeks by last menstrual date or ultrasound report if uncertain date

排除标准

  • Multifetal gestation
  • Miscarriage before first trimester ultrasound
  • Loss to follow up at mid-trimester ultrasound scan
  • Loss to follow up after birth

结局指标

主要结局

Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators

时间窗: 3 months

To compare the percentage of completed scans of each organ during the first trimester scan between two different levels of proficiency

次要结局

  • Learning curve of first trimester ultrasound scans between two different levels of proficiency operators(3 months)
  • Screening time for first trimester ultrasound scans between two different levels of proficiency operators(3 months)
  • Detection rate of fetal structural abnormality in first trimester ultrasound scans between two different levels of proficiency operators(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Saranthorn Sripilaipong

Doctor

Mahidol University

研究点 (2)

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