Clinical trial Recruiting at 1 site Observational Ages 18 to 44 Women only

Evaluating 3D Ultrasound for Anal Sphincter Assessment

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

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06773520 · Data updated 2026-11-12

This study is testing new 3D ultrasound techniques to see how well they can check the condition of the anal sphincter in pregnant women and new mothers to better understand related injuries and symptoms.

Quick facts

Study typeObservational
Ages18 Years to 44 Years
SexWomen only
Enrollment200 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Locations1 site (Bologna, Bologna)
StatusRecruiting
StartedNovember 21, 2023
Main results expectedAugust 31, 2027
Study endsAugust 31, 2027
Registry record updatedJanuary 14, 2025
Trial IDNCT06773520 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are pregnant nulliparous or primiparous women aged 18 to 44 years.

Probably not a fit

Patients who are not pregnant or outside the age range of 18 to 44 years may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the reproducibility of advanced 3D and 4D ultrasound techniques in evaluating the integrity and thickness of the anal sphincter during pregnancy and immediately postpartum. By utilizing a transvaginal probe, the study seeks to enhance the understanding of obstetric anal sphincter injuries (OASIS) and their impact on women's quality of life. The primary objective is to determine how reliably these new ultrasound methods can measure anal sphincter conditions, while secondary objectives include exploring the correlation between sphincter thickness and postpartum symptoms. The study will involve blinded assessments to minimize bias.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic techniques for anal sphincter injuries, enhancing the quality of life for affected women.

How similar studies have gone: While there is limited research specifically on 3D/4D ultrasound for this purpose, advancements in ultrasound technology have shown promise in related fields.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

None

Where it's running

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, Bologna, Italy
    Recruiting

Study contacts

  • Principal investigator: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Study coordinator: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
  • Email: aly.youssef@aosp.bo.it
  • Phone: 0512144412

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.