Evaluating 3D Ultrasound for Anal Sphincter Assessment
Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation: "A New Technique"
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06773520 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant nulliparous or primiparous women aged 18 to 44 years.
Not a fit: Patients who are not pregnant or outside the age range of 18 to 44 years may not benefit from this study.
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 performed: While there is limited research specifically on 3D/4D ultrasound for this purpose, advancements in ultrasound technology have shown promise in related fields.
Eligibility criteria
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 this trial is running
Bologna, Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.