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临床试验/NCT04707456
NCT04707456
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A Comparative Study of Learning Curve Between Two Different Levels of Proficiency for First Trimester Fetal Anomaly Scan Using ISUOG Guidelines

Mahidol University1 个研究点 分布在 1 个国家目标入组 210 人2020年6月11日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
First Trimester Pregnancy
发起方
Mahidol University
入组人数
210
试验地点
1
主要终点
Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators
最后更新
5年前

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.

注册库
clinicaltrials.gov
开始日期
2020年6月11日
结束日期
2021年2月
最后更新
5年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Saranthorn Sripilaipong

Doctor

Mahidol University

入排标准

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)

研究点 (1)

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