Actively Recruiting
Evaluating New 3D4D Transvaginal Ultrasound Techniques to Assess Anal Sphincter During Pregnancy and After Birth
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-14
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating new 3D and 4D ultrasound techniques to examine the anal sphincter in women during pregnancy and shortly after childbirth. This observational study focuses on improving the understanding and assessment of obstetric anal sphincter injuries OASIS, which can affect womens quality of life by potentially causing anal incontinence. The study particularly explores how these imaging methods can better define sphincter anatomy and detect related injuries. The study uses novel volume analysis methods, including curvilinear reconstruction and contrast enhancement, to assess the anal sphincters integrity and thickness. These techniques are applied to ultrasound volumes obtained during routine prepartum and postpartum visits. Multiple operators perform blinded assessments to reduce bias, with repeated measurements spaced at least one month apart. The goal is to test the reproducibility and feasibility of these new analysis methods without requiring additional patient visits beyond usual care. Participants will undergo standard clinical visits where ultrasound volumes are collected and later analyzed offline by trained clinicians. Researchers will measure consistency between operators and relate sphincter thickness to postpartum symptoms like rectal incontinence. The study tracks reproducibility using statistical measures such as the intraclass correlation coefficient. Overall, the study lasts from late pregnancy to the postpartum period, with no extra procedures beyond routine care and no intervention affecting treatment plans.
CONDITIONS
Brief Title
Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation
Research Team
A
Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
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