Clinical Trials Directory

Trials / Completed

CompletedNCT06441929

Pregnancy Ultrasound Satisfaction Scoring System

How Difficult a Fetal Ultrasound Can be: Time for a Dedicated Classification System

Status
Completed
Phase
Study type
Observational
Enrollment
500 (actual)
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2023-03-01
Primary completion
2024-03-01
Completion
2024-03-28
First posted
2024-06-04
Last updated
2024-06-04

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06441929. Inclusion in this directory is not an endorsement.