Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan

First Trimester Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04707456
• Other study ID #: COA. MURA2020/303
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: February 2021

Study information

• Verified date: January 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: February 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• First Trimester Pregnancy

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Obstetrics and Gynecology, Faculty of Medicine Ramathibodi hospital, Mahidol university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (9)

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. — View Citation

Karim JN, Roberts NW, Salomon LJ, Papageorghiou AT. Systematic review of first-trimester ultrasound screening for detection of fetal structural anomalies and factors that affect screening performance. Ultrasound Obstet Gynecol. 2017 Oct;50(4):429-441. doi: 10.1002/uog.17246. Epub 2017 Sep 7. Review. — View Citation

Nicolaides KH. Nuchal translucency and other first-trimester sonographic markers of chromosomal abnormalities. Am J Obstet Gynecol. 2004 Jul;191(1):45-67. Review. — View Citation

Pangkanon S, Sawasdivorn S, Kuptanon C, Chotigeat U, Vandepitte W. Establishing of National Birth Defects Registry in Thailand. J Med Assoc Thai. 2014 Jun;97 Suppl 6:S182-8. — View 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. — View 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. Erratum in: Ultrasound Obstet Gynecol. 2013 Feb;41(2):240. — View Citation

Salvesen K, Lees C, Abramowicz J, Brezinka C, Ter Haar G, Maršál 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. — View 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. — View Citation

Taipale P, Ammälä 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	9 months