Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan
Primary Purpose
First Trimester Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Training operator
Sponsored by
About this trial
This is an interventional diagnostic trial for First Trimester Pregnancy focused on measuring First trimester ultrasound scan, Learning curve, ISUOG practice guidelines
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
Sites / Locations
- Department of Obstetrics and Gynecology, Faculty of Medicine Ramathibodi hospital, Mahidol university
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
MFM staff-level operator
MFM fellowship trainee-level operator
Arm Description
Outcomes
Primary Outcome Measures
Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators
To compare the percentage of completed scans of each organ during the first trimester scan between two different levels of proficiency
Secondary Outcome Measures
Screening time for first trimester ultrasound scans between two different levels of proficiency operators
To compare screening time for first trimester ultrasound scans between two different levels of proficiency operators
Learning curve of first trimester ultrasound scans between two different levels of proficiency operators
To compare the learning curve 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
To compare the detection rate of fetal structural abnormality between two different levels of proficiency operators
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04707456
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Trimester Pregnancy
Keywords
First trimester ultrasound scan, Learning curve, ISUOG practice guidelines
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MFM staff-level operator
Arm Type
No Intervention
Arm Title
MFM fellowship trainee-level operator
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Training operator
Intervention Description
After recruitment, the participants were divided into two groups to perform first-trimester ultrasound scan by two different levels of proficiency.
First group : operator has experience more than 3 years in NT scan and second trimester ultrasound scan Second group : operator has experience less than 3 years in NT scan and second trimester ultrasound scan
Primary Outcome Measure Information:
Title
Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators
Description
To compare the percentage of completed scans of each organ during the first trimester scan between two different levels of proficiency
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Screening time for first trimester ultrasound scans between two different levels of proficiency operators
Description
To compare screening time for first trimester ultrasound scans between two different levels of proficiency operators
Time Frame
3 months
Title
Learning curve of first trimester ultrasound scans between two different levels of proficiency operators
Description
To compare the learning curve between two different levels of proficiency operators
Time Frame
3 months
Title
Detection rate of fetal structural abnormality in first trimester ultrasound scans between two different levels of proficiency operators
Description
To compare the detection rate of fetal structural abnormality between two different levels of proficiency operators
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Faculty of Medicine Ramathibodi hospital, Mahidol university
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18185492
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan
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