Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan

NCT04707456 | Unknown DMC

• 1 other identifier: COA. MURA2020/303
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

First Trimester Pregnancy

Keywords

First trimester ultrasound scan; Learning curve; ISUOG practice guidelines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  3 months

• Detection rate of fetal structural abnormality in first trimester ultrasound scans between two different levels of proficiency operators

  9 months

Study Arms (2)

MFM staff-level operator

NO INTERVENTION

MFM fellowship trainee-level operator

OTHER

Other: Training operator

Interventions

Training operator OTHER

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

MFM fellowship trainee-level operator

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy
• Maternal age ≥ 18 years
• Gestational age between 11-13 + 6 weeks by last menstrual date or ultrasound report if uncertain date

You may not qualify if:

• Multifetal gestation
• Miscarriage before first trimester ultrasound
• Loss to follow up at mid-trimester ultrasound scan
• Loss to follow up after birth

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Faculty of Medicine Ramathibodi hospital, Mahidol university

Bangkok, 10400, Thailand

Location

Related 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.

  PMID: 18185492 BACKGROUND

• 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.

  PMID: 25391192 BACKGROUND

• 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.

  PMID: 27546497 BACKGROUND

• 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.

  PMID: 12576250 BACKGROUND

• 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.

  PMID: 23280739 BACKGROUND

• 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.

  PMID: 16756041 BACKGROUND

• 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.

  PMID: 30612473 BACKGROUND

• 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.

  PMID: 15295343 BACKGROUND

• 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.

  PMID: 21618313 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: June 11, 2020
• Primary Completion: August 31, 2020
• Study Completion: February 1, 2021
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)