Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan

January 11, 2021 updated by: Saranthorn Sripilaipong, Mahidol University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Department of Obstetrics and Gynecology, Faculty of Medicine Ramathibodi hospital, Mahidol university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: MFM staff-level operator
Other: MFM fellowship trainee-level operator
Other: Training operator

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening time for first trimester ultrasound scans between two different levels of proficiency operators
Time Frame: 3 months
To compare screening time for first trimester ultrasound scans between two different levels of proficiency operators
3 months
Learning curve of first trimester ultrasound scans between two different levels of proficiency operators
Time Frame: 3 months
To compare the learning curve 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
Time Frame: 9 months
To compare the detection rate of fetal structural abnormality between two different levels of proficiency operators
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Actual)

August 31, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA. MURA2020/303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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