Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-44
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Intraclass correlation coefficient (ICC)

Bland-Altman analysis

Time frame
At the end of pregnancy (up to 40 weeks of gestation)
2

Presence of a systematic difference between the various measures taken by different operators

Bland-Altman analysis

Time frame
At the end of pregnancy (up to 40 weeks of gestation)
3

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

Time frame
At the end of pregnancy (up to 40 weeks of gestation)

Secondary outcomes

1

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.

Time frame
At the end of pregnancy (up to 40 weeks of gestation)
2

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

Time frame
At the end of pregnancy (up to 40 weeks of gestation)

Other outcomes

Sponsors and contacts

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