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Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06773520
Acronym
3D_TV_OASIS
Enrollment
200
Registered
2025-01-14
Start date
2023-11-21
Completion date
2027-08-31
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Anal Sphincter Injury

Keywords

3D untrasound

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.

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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Presence of a systematic difference between the various measures taken by different operatorsAt the end of pregnancy (up to 40 weeks of gestation)Bland-Altman analysis
Intraclass correlation coefficient (ICC)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

Secondary

MeasureTime frameDescription
Percentage of volumes acquired in which measurement of the external anal sphincter will be feasibleAt the end of pregnancy (up to 40 weeks of gestation)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 incontinenceAt the end of pregnancy (up to 40 weeks of gestation)Comparison of anal sphincter thickness between women with and without exintent signs of rectal incontinence at postpartum visit

Countries

Italy

Contacts

Primary ContactAly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
aly.youssef@aosp.bo.it0512144412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026