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First Trimester PregnancyNCT04707456

Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan

A study testing Training operator in people with First Trimester Pregnancy, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
First Trimester Pregnancy
What is being tested?
Training operator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteThailand
Study dates
11 Jun 2020to Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

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

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
Training operator
Keywords
First trimester ultrasound scan, Learning curve, ISUOG practice guidelines

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training operatorOther

    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

Study groups in NCT04707456
Study groupRoleWhat they receive
MFM staff-level operatorNo interventionNot described
MFM fellowship trainee-level operatorOtherNot described
Receives: Other: Training operator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (3)

  1. 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

    Measured: 3 months

  2. 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

    Measured: 3 months

  3. 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

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start11 Jun 2020
  3. Primary completion31 Aug 2020
  4. Study completionFeb 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04707456
Sponsor's protocol ID
COA. MURA2020/303
Status last verified
Jan 2021
First submitted
11 Jan 2021
Last updated
13 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18185492

  • 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.

    PubMed 25391192

  • 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.

    PubMed 27546497

  • 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.

    PubMed 12576250

  • 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.

    PubMed 23280739

  • 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.

    PubMed 16756041

  • 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.

    PubMed 30612473

  • 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.

    PubMed 15295343

  • 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.

    PubMed 21618313

Questions about this trial

What is this clinical trial studying?

A study testing Training operator in people with First Trimester Pregnancy, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of completed scans of fetal structural abnormality between two different levels of proficiency operators (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04707456, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.

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