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临床试验/NCT06441929
NCT06441929已完成不适用

How Difficult a Fetal Ultrasound Can be: Time for a Dedicated Classification System

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
Operator ultrasound satisfaction

研究概览

简要总结

Sonographic imaging stands as the mainstay of fetal anatomical investigation and the primary screening tool for structural abnormalities early in pregnancy. This study aimed to evaluate the occurrence and effect of a cluster of maternal features on sonographic image quality and operator satisfaction.

详细描述

This was a cross-sectional, single-center observational study of ultrasound scans performed on singleton pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation. From March 2023 to March 2024, a convenience cohort of pregnant women who presented for prenatal care at the Fetal Medicine and Prenatal Diagnosis Unit of "Di Venere" Hospital in Bari (Apulia, Southern Italy) and the Obstetrics and Gynecology Unit of Vito Fazzi Hospital in Lecce (Apulia, Southern Italy) to receive routine gestational ultrasound was recruited for the present study.

The inclusion criteria were singleton pregnancy and the presence of one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI>24.9 Kg/m2), retroverted uterus, the presence of myomas, a previous abdominal surgery, and a limited echo absorption. No exclusion criteria related to women's gestational age or ethnicity were applied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women presenting one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI>24.9 Kg/m2), retroverted uterus, the presence of myomas, previous abdominal surgery, and limited echo absorption.

排除标准

  • No limiting factors described above
  • No pregnant women

结局指标

主要结局

Operator ultrasound satisfaction

时间窗: baseline

Operator ultrasound satisfaction, rating as "low", "good", or "very good"

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberta Zupo

PhD

University of Bari Aldo Moro

研究点 (1)

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