Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan

Not Applicable

• Conditions: First Trimester Pregnancy
• Interventions: Other: Training operator

• Registration Number: NCT04707456
• Lead Sponsor: Mahidol University

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 Timeline

• Study Start: 2020-06-11
• Primary Completion: 2020-08-31
• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-13
• Last Update Posted: 2021-01-13
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MFM fellowship trainee-level operator	Training operator	-

Primary Outcome Measures

Name	Time	Method
Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators	3 months	To compare the percentage of completed scans of each organ during the first trimester scan between two different levels of proficiency

Secondary Outcome Measures

Name	Time	Method
Learning curve of first trimester ultrasound scans between two different levels of proficiency operators	3 months	To compare the learning curve between two different levels of proficiency operators
Screening time for first trimester ultrasound scans between two different levels of proficiency operators	3 months	To compare screening time for first trimester ultrasound scans between two different levels of proficiency operators
Detection rate of fetal structural abnormality in first trimester ultrasound scans between two different levels of proficiency operators	9 months	To compare the detection rate of fetal structural abnormality between two different levels of proficiency operators

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Faculty of Medicine Ramathibodi hospital, Mahidol university; 🇹🇭 Bangkok, Thailand