Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation

NCT06773520 | Recruiting

• 1 other identifier: 3D_TV_OASIS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstetric Anal Sphincter Injury

Keywords

3D untrasound

Outcome Measures

Primary Outcomes (3)

• Intraclass correlation coefficient (ICC)

  Bland-Altman analysis

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

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

  Bland-Altman analysis

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

• 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

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

Secondary Outcomes (2)

• Percentage of volumes acquired in which measurement of the external anal sphincter will be feasible

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

• Correlation between anal sphincter thickness and the presence of symptoms related to rectal incontinence

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

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Pregnant nulliparous or primiparous women;
• Age between 18 and 44 years
• Acquisition of informed consent form

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

• Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD

CONTACT

0512144412; aly.youssef@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 14, 2025
• Study Start: November 21, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 14, 2025

Record last verified: 2024-10

Locations

IT (1)