Clinical trial NCT04707456: Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan
Official title: A Comparative Study of Learning Curve Between Two Different Levels of Proficiency for First Trimester Fetal Anomaly Scan Using ISUOG Guidelines
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: First Trimester Pregnancy
Keywords: First trimester ultrasound scan
Learning curve
ISUOG practice guidelines
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators
timeFrame: 3 months
Secondary outcomes:
measure: Screening time for first trimester ultrasound scans between two different levels of proficiency operators
timeFrame: 3 months
measure: Learning curve of first trimester ultrasound scans between two different levels of proficiency operators
timeFrame: 3 months
measure: Detection rate of fetal structural abnormality in first trimester ultrasound scans between two different levels of proficiency operators
timeFrame: 9 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Obstetrics and Gynecology, Faculty of Medicine Ramathibodi hospital, Mahidol university
Study officials:
References:
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