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Clinical Trials/NCT04707456
NCT04707456UnknownNot Applicable

A Comparative Study of Learning Curve Between Two Different Levels of Proficiency for First Trimester Fetal Anomaly Scan Using ISUOG Guidelines

Mahidol University2 sites in 1 country210 target enrollmentStarted: June 11, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
210
Locations
2
Primary Endpoint
Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators

Study Overview

Brief Summary

Ultrasound scans during first trimester are more difficult than routine mid-trimester ultrasound scans. Practice guidelines for first trimester fetal ultrasound scans have been provided by the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) since 2013. Using this guidelines, different levels of proficiency operators might have equal ability to complete first trimester ultrasound scans.

Detailed Description

Nowadays, high-resolution transabdominal ultrasounds are widely used, and ultrasound scans for fetal structural abnormalities at the first trimester are indeed possible. First trimester ultrasound scans are important and essential for detecting fetal structural anomalies, and they help provide optimized early antenatal management. However, ultrasound scans, during this period, are more difficult than routine mid-trimester ultrasound scans, as fetal organs are small and experienced operators are needed to use the transducer to obtain informative pictures. Practice guidelines for first trimester fetal ultrasound scans have been provided by the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) since 2013. Since then, the percentage of complete scans and the high detection rate of fetal structural abnormalities during first trimester ultrasound scans have been reported. From our perspective, ultrasound operators who have different experiences in mid-trimester ultrasound scanning might have equal ability to complete first trimester ultrasound scans using the ISUOG guidelines. The objective of this study is to compare the rate of completed scans regarding fetal structures at the first trimester ultrasound scan between two different levels of proficiency operators.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Singleton pregnancy
  • Maternal age ≥ 18 years
  • Gestational age between 11-13 + 6 weeks by last menstrual date or ultrasound report if uncertain date

Exclusion Criteria

  • Multifetal gestation
  • Miscarriage before first trimester ultrasound
  • Loss to follow up at mid-trimester ultrasound scan
  • Loss to follow up after birth

Outcomes

Primary Outcomes

Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators

Time Frame: 3 months

To compare the percentage of completed scans of each organ during the first trimester scan between two different levels of proficiency

Secondary Outcomes

  • Learning curve of first trimester ultrasound scans between two different levels of proficiency operators(3 months)
  • Screening time for first trimester ultrasound scans between two different levels of proficiency operators(3 months)
  • Detection rate of fetal structural abnormality in first trimester ultrasound scans between two different levels of proficiency operators(9 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Saranthorn Sripilaipong

Doctor

Mahidol University

Study Sites (2)

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