Pregnancy Ultrasound Satisfaction Scoring System

Completed

• Conditions: Ultrasound Satisfaction in Pregnant Women

• Registration Number: NCT06441929
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief Summary

Sonographic imaging stands as the mainstay of fetal anatomical investigation and the primary screening tool for structural abnormalities early in pregnancy. This study aimed to evaluate the occurrence and effect of a cluster of maternal features on sonographic image quality and operator satisfaction.

Detailed Description

This was a cross-sectional, single-center observational study of ultrasound scans performed on singleton pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation. From March 2023 to March 2024, a convenience cohort of pregnant women who presented for prenatal care at the Fetal Medicine and Prenatal Diagnosis Unit of "Di Venere" Hospital in Bari (Apulia, Southern Italy) and the Obstetrics and Gynecology Unit of Vito Fazzi Hospital in Lecce (Apulia, Southern Italy) to receive routine gestational ultrasound was recruited for the present study.

The inclusion criteria were singleton pregnancy and the presence of one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI\>24.9 Kg/m2), retroverted uterus, the presence of myomas, a previous abdominal surgery, and a limited echo absorption. No exclusion criteria related to women's gestational age or ethnicity were applied.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-28
• Status Verified: 2024-05
• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-05-29
• Last Update Submitted: 2024-05-29
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

Pregnant women presenting one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI>24.9 Kg/m2), retroverted uterus, the presence of myomas, previous abdominal surgery, and limited echo absorption.

Exclusion Criteria

• No limiting factors described above
• No pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Operator ultrasound satisfaction	baseline	Operator ultrasound satisfaction, rating as "low", "good", or "very good"

Trial Locations

Locations (1)

University of Bari Aldo Moro; 🇮🇹 Bari, Italy