Actively Recruiting
Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation Evaluating New 3D/4D Techniques During Pregnancy and Postpartum
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-14
200
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new 3D and 4D ultrasound volume analysis techniques to assess the integrity and thickness of the anal sphincter during pregnancy and immediately after childbirth. This study focuses on Obstetric Anal Sphincter Injuries (OASIS), which can negatively affect women's quality of life, and aims to improve diagnosis and management of these injuries through advanced imaging methods. The study explores how these new volumetric ultrasound methods, including curvilinear reconstruction and contrast enhancement, can help better understand pelvic floor anatomy and lesion detection. The study uses novel ultrasound techniques conducted offline on volumes obtained during routine prenatal and postpartum visits. Multiple operators will independently analyze these images without knowing the patient's history or other measurements to reduce bias. Operators performing multiple measurements will space them at least one month apart. There are no additional visits or treatments required beyond standard clinical care. Participants will undergo routine ultrasound assessments during pregnancy and postpartum, and researchers will evaluate the reproducibility of these imaging techniques by comparing measures taken by different operators. They will also examine the relationship between anal sphincter thickness, ultrasound integrity, and postpartum symptoms. Outcomes include statistical measures of agreement between operators and the spread of measurement differences. The total participation duration corresponds to the standard prenatal and postpartum care timeline, up to 40 weeks of gestation.
CONDITIONS
Official Title
Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant nulliparous or primiparous women
- Age between 18 and 44 years
- Acquisition of informed consent form
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
A
Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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