Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation (3D_TV_OASIS)

Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation: "A New Technique"

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.

Study Overview

• Status: Recruiting
• Conditions: Obstetric Anal Sphincter Injury

Detailed Description

The development of ultrasound techniques such as 3D and 4D and new reproducible and increasingly accurate volumetric acquisition modalities shows promise for improving the diagnosis of OASIS and the clinical management of OASIS and consequently the quality of life of women.

With new, simpler techniques of 3D/4D volume analysis of the anal sphincter, the number of operators able to objectively and accurately assess anal sphincter integrity, both in the delivery room and postpartum, could increase. The application and dissemination of an accurate and reproducible technique in the subjective assessment of the anal sphincter could help operators improve and refine the technique of surgical correction of anal sphincter injuries.

The primary objective of the study is to evaluate the reproducibility of novel 3D/4D ultrasound volume analysis techniques, using curvilinear reconstruction of the coronal plane of the anal sphincter combined with contrast enhancement technique (optic OMNIVIEW), in the assessment of anal sphincter integrity and thickness, both in pregnancy and immediate postpartum.

Secondary objectives include:

• Evaluation of the feasibility of new off-line analysis techniques.
• Evaluation of the correlation between thickness and ultrasound integrity of the anal sphincter at the postpartum visit and women's symptomatology in the postpartum.

To reduce bias as much as possible, each operator during each assessment will be "blinded" to the patient's history and all other measurements.

Clinicians who perform more than one measurement per volume will do so at least one month apart between each measurement.

The patient will be treated according to common clinical practice ensuring the standard of care. Patients will not undertake additional visits to those routinely performed. This is an evaluation of new techniques for off-line (in the absence of the patient) analysis of ultrasound volumes that are currently part of routine visits in both pre and postpartum.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD; Phone Number: 0512144412; Email: aly.youssef@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD; Phone Number: 0512144412; Email: aly.youssef@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Comparison of anal sphincter thickness between women with and without exintent signs of rectal incontinence at postpartum visit	At the end of pregnancy (up to 40 weeks of gestation)

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: 3D untrasound
• Other Study ID Numbers: 3D_TV_OASIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No