The Reproducibility of Microvascular Flow Imaging in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes

Completed

• Conditions: Fibroid Uterus

• Registration Number: NCT05643339
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-11-01
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-08
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• one or more uterine fibroids
• diameter between 1,5 and 12 cm
• fibroid easily recognizable on ultrasound

Exclusion Criteria

• younger than 18 years
• pregnancy
• uterine or cervical malignancy
• adenomyosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reproducibility by inter- and intraobserver agreement	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.

Secondary Outcome Measures

Name	Time	Method
penetration in centimeters	Day 1	The penetration was measured along the direction of the ultrasound wave, from the probe to the deepest ultrasound signal visible, both for Microvascular Flow and power Doppler. Differences in ordinal data was tested by Mann Whitney U, non-normal continuous data by Wilcoxon rank test and normally distributed continuous data by a one sample t-test.
architecture	Day 1	architecture of vessels visible in different regions yes/no.
presence doppler signal	Day 1	yes/no in different regions

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands