An observational study in Adenomyosis, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
Defining ultrasound criteria for normal uterine biometry and assessing the prevalence of repeat abortions in patients with abnormalities of the uterine cavity
Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of glands and endometrial stroma within the myometrium, associated or not with hypertrophy and hyperplasia of the surrounding myometrium. Adenomyosis may cause pelvic pain and/or abnormal uterine bleeding. Transvaginal ultrasound may be considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis. The aim is to optimise the ultrasound diagnosis of uterine pathology and in particular of adenomyosis by defining uterine biometric parameters (longitudinal, transverse and anteroposterior diameters and their ratios; uterine volume) allowing patients to be divided into 3 groups:
135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.
This study's planned enrollment of 465 is above the median of 150 across 56 observational studies indexed under Adenomyosis.
Browse Adenomyosis studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
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
Time frame: 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
Time frame: After enrollment on first visit
Construction of deep learning models on uterine ultrasound images
Construction of deep learning models trained, validated and tested on uterine ultrasound images for the ultrasound diagnosis of adenomyosis and evaluation of their diagnostic accuracy
Time frame: After enrollment on first visit
Evaluation of diagnostic accuracy of deep learning validated
Evaluation of diagnostic accuracy of deep learning validated for ultrasound diagnosis of adenomyosis
Time frame: After enrollment on first visit
Identification of the frequency of finding ultrasound signs of adenomyosis in the cervix
In patients with a diagnosis of adenomyosis made on the basis of ultrasound features at the level of the uterine body and fundus
Time frame: After enrollment on first visit
Evaluation of diagnostic accuracy
Evaluation of the diagnostic accuracy of trainees when experienced (identifying experienced operators as doctors in specialised training in Gynaecology and Obstetrics for at least four years, with an experience of at least 500 gynaecological ultrasound cases) and moderately experienced (identifying moderately experienced operators as doctors in specialised training in Gynaecology and Obstetrics for at least two years, with an experience of at least 200 gynaecological ultrasound cases
Time frame: After enrollment on first visit
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IRCCS Azienda Ospedaliero-Universitaria di Bologna