Sponsor study identifier
observational
465
1 country
1
Study Start
April 4, 2022
Actual (reported)Primary Completion
December 31, 2024
Actual (reported)Study Completion
March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Defining ultrasound criteria for normal uterine biometry and assessing the prevalence of repeat abortions in patients with abnormalities of the uterine cavity
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 4, 2022
Actual (reported)December 3, 2024
Actual (reported)December 31, 2024
Actual (reported)January 28, 2025
Actual (reported)March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Definition of uterine biometric parameters
Definition of uterine biometric parameters for the diagnosis of adenomyotic uterus (group A), fibromatous uterus (group B) and normal uterus (group C) by means of transvaginal ultrasound, performed as per the care procedure. Evaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off
After enrollment on first visit
Diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis
Evaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off
After enrollment on first visit
Construction of deep learning models on uterine ultrasound images
After enrollment on first visit
Evaluation of diagnostic accuracy of deep learning validated
After enrollment on first visit
Identification of the frequency of finding ultrasound signs of adenomyosis in the cervix
After enrollment on first visit
Evaluation of diagnostic accuracy
After enrollment on first visit
Patients consecutively attending our ultrasound clinics for routine check-ups or pre-operative examinations will be included, as per regular practice. For the purposes of the analysis, patients will be divided into three groups according to the ultrasound and/or surgical diagnosis of A adenomyosis (presence of at least 2 ultrasound signs compatible with adenomyosis (MUSA) or presence of glands and endometrial stroma in myometrial location), B fibromatosis (uterus with inhomogeneous echostructure lacking 2 or more signs compatible with uterine adenomyosis or histological finding of several benign tumours consisting of smooth muscle tissue and fibrous tissue in varying proportions), C normal uterus (normal echostructure on transvaginal ultrasound)
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138, Italy
Diego Raimondo, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
First Submitted
December 3, 2024
First Posted
January 28, 2025
Study Start
April 4, 2022
Actual (reported)Primary Completion
December 31, 2024
Actual (reported)Role of Uterine Artery Embolization in Adenomyosis
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Study Completion
March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 28, 2025
Record last verified: 2024-11
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