Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation

Condition(s) studied

Study summary

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

Primary outcome measure(s)

• Intraclass correlation coefficient (ICC) — At the end of pregnancy (up to 40 weeks of gestation)
  Bland-Altman analysis
• Presence of a systematic difference between the various measures taken by different operators — At the end of pregnancy (up to 40 weeks of gestation)
  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. — At the end of pregnancy (up to 40 weeks of gestation)
  Bland-Altman analysis

Trial sites (1)

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy