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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
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

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

First Posted
January 11, 2021
Last Updated
January 11, 2021
Sponsor
Mahidol University
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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
Centers for Disease Control and Prevention (CDC). Update on overall prevalence of major birth defects--Atlanta, Georgia, 1978-2005. MMWR Morb Mortal Wkly Rep. 2008 Jan 11;57(1):1-5.
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
12576250
Citation
Taipale P, Ammala M, Salonen R, Hiilesmaa V. Learning curve in ultrasonographic screening for selected fetal structural anomalies in early pregnancy. Obstet Gynecol. 2003 Feb;101(2):273-8. doi: 10.1016/s0029-7844(02)02590-5.
Results Reference
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PubMed Identifier
23280739
Citation
Salomon LJ, Alfirevic Z, Bilardo CM, Chalouhi GE, Ghi T, Kagan KO, Lau TK, Papageorghiou AT, Raine-Fenning NJ, Stirnemann J, Suresh S, Tabor A, Timor-Tritsch IE, Toi A, Yeo G. ISUOG practice guidelines: performance of first-trimester fetal ultrasound scan. Ultrasound Obstet Gynecol. 2013 Jan;41(1):102-13. doi: 10.1002/uog.12342. No abstract available. Erratum In: Ultrasound Obstet Gynecol. 2013 Feb;41(2):240.
Results Reference
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PubMed Identifier
16756041
Citation
Srisupundit K, Tongsong T, Sirichotiyakul S, Chanprapaph P. Fetal structural anomaly screening at 11-14 weeks of gestation at Maharaj Nakorn Chiang Mai Hospital. J Med Assoc Thai. 2006 May;89(5):588-93.
Results Reference
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PubMed Identifier
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Citation
Petousis S, Sotiriadis A, Margioula-Siarkou C, Tsakiridis I, Christidis P, Kyriakakis M, Mamopoulos A, Athanasiadis A, Dagklis T. Detection of structural abnormalities in fetuses with normal karyotype at 11-13 weeks using the anatomic examination protocol of the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG). J Matern Fetal Neonatal Med. 2020 Aug;33(15):2581-2587. doi: 10.1080/14767058.2018.1555807. Epub 2019 Jan 7.
Results Reference
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PubMed Identifier
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Citation
Nicolaides KH. Nuchal translucency and other first-trimester sonographic markers of chromosomal abnormalities. Am J Obstet Gynecol. 2004 Jul;191(1):45-67. doi: 10.1016/j.ajog.2004.03.090.
Results Reference
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PubMed Identifier
21618313
Citation
Salvesen K, Lees C, Abramowicz J, Brezinka C, Ter Haar G, Marsal K; Board of International Society of Ultrasound in Obstetrics and Gynecology (ISUOG). ISUOG statement on the safe use of Doppler in the 11 to 13 +6-week fetal ultrasound examination. Ultrasound Obstet Gynecol. 2011 Jun;37(6):628. doi: 10.1002/uog.9026. No abstract available.
Results Reference
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Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan

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