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 type | Observational |
|---|---|
| Ages | 18 Years to 44 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | November 21, 2023 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | January 14, 2025 |
| Trial ID | NCT06773520 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
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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
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Group-based follow-up for women after obstetric anal sphincter injury
A group-based follow-up program is being tested to see if it can improve quality of life for women who had a tear at the anal sphincter after childbirth.
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Physiotherapy and cold‑pack treatment for first-time mothers with perineal tears after vaginal delivery
This will test whether pelvic floor muscle exercises plus cryotherapy started right after birth reduce perineal pain for first-time mothers who had a grade 2 or higher tear or an episiotomy.
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Pelvic floor exercise program for weak anal sphincter after childbirth
This program will try guided pelvic floor exercises to see if they improve anal squeeze strength in women who had an obstetric anal sphincter injury and low anorectal manometry readings.
-
Care pathways for women with obstetric anal sphincter injury-related incontinence
This study looks at how women with incontinence from childbirth-related injuries are currently cared for to see if better support can be provided.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.