About this trial
The goal of this observational study is to evaluate the reproducibility of new 3D/4D ultrasound volume analysis techniques in the assessment of anal sphincter integrity and thickness in both pregnancy and immediate postpartum.
The negative impact that OASISs (Obstetric Anal Sphincter Injuries), and possible subsequent anal incontinence, have on women's quality of life has stimulated research in this field in recent decades. However, there are still few studies concerning the topic. The transperineal approach by means of the transvaginal probe in the study of the pelvic floor, anal sphincter and related lesions has helped us to make strides in our knowledge of the anatomy of the pelvic floor and in defining the lesions that may affect it.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant nulliparous or primiparous women;
Age between 18 and 44 years
Acquisition of informed consent form
Disqualifiers
None
Trial population
Nulliparous and primiparous pregnant women. Participants will be enrolled at the Division of Obstetrics and Prenatal Age Medicine (IRCCS - Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola). Participants will be enrolled during the obstetrical visit or during hospitalization or during visits in the postpartum period.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Intraclass correlation coefficient (ICC)
Bland-Altman analysis
Presence of a systematic difference between the various measures taken by different operators
Bland-Altman analysis
Dispersion of the differences between the measures taken by two different operators and the two measures taken by the same operator around the mean of the respective differences.
Bland-Altman analysis
Secondary outcomes
Percentage of volumes acquired in which measurement of the external anal sphincter will be feasible
New analysis techniques: curvilinear reconstruction of the coronal plane of the anal sphincter combined with contrast enhancement technique.
Correlation between anal sphincter thickness and the presence of symptoms related to rectal incontinence
Comparison of anal sphincter thickness between women with and without exintent signs of rectal incontinence at postpartum visit
Sponsors and contacts
Click on the lead sponsor to view all of their trials.