The Reproducibility of Microvascular Flow in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- reproducibility by inter- and intraobserver agreement
研究概览
简要总结
The investigators hypothesized that Macrovascular Flow imaging could contribute to 2D power Doppler and 3D power Doppler in depicting fibroid vascularity. However, data concerning the feasibility and reproducibility of Macrovascular Flow imaging is lacking. Therefore the purpose of our study was to determine 1) the reproducibility of Macrovascular Flow imaging, 2) its correlation with 2D and 3D power Doppler, and 3) penetration depth, in order to investigate the added value for daily clinical practice.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •one or more uterine fibroids
- •diameter between 1,5 and 12 cm
- •fibroid easily recognizable on ultrasound
排除标准
- •younger than 18 years
- •pregnancy
- •uterine or cervical malignancy
- •adenomyosis.
结局指标
主要结局
reproducibility by inter- and intraobserver agreement
时间窗: Day 1
The primary outcome was calculated by the assessment of intercorrelation coefficient (ICC) and its 95% confidence interval (CI) using a two-way mixed model. An ICC value of 0.75-1.00 indicates a good to excellent agreement(19). Bland-Altman plots showed the distribution of data.
次要结局
- penetration in centimeters(Day 1)
- architecture(Day 1)
- presence doppler signal(Day 1)
研究者
Marjolein Spiering
Investigator Reseach Office Womens Child Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)