Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan

Mahidol University

Status: Unknown

Conditions: First Trimester Pregnancy

Treatments: Other: Training operator

Study type: Interventional

Funder types: Other

Identifiers

NCT04707456

COA. MURA2020/303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

MFM staff-level operator

No Intervention group

MFM fellowship trainee-level operator

Other group

Treatment:

Other: Training operator