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Effects of different levels of proficiency operators on transvaginal first trimester anatomical screening: A randomized control trial

Effects of different levels of proficiency operators on transvaginal first trimester anatomical screening: A randomized control trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250309014
Enrollment
310
Registered
2025-03-09
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feasibility of first trimester anatomical ultrasound between different levels of proficiency operators First trimester anatomical scan Transvaginal ultrasound Feasibility

Interventions

First trimester transvaginal anatomy scanning by a first year MFM fellow with two years of experience in second trimester anatomy screening who had been trained to perform nuchal translucency measurem
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Low level of experience,High level of experience

Sponsors

Ramathibodi hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Singleton pregnancy - Maternal age of 18 years or greater - GA between 11 and 13+6 weeks (based on a well-defined last menstrual period or CRL from ultrasound scanning)

Exclusion criteria

Exclusion criteria: - Major fetal structural anomalies detected on either the first or second-trimester ultrasound scan - Prenatally diagnosed chromosomal abnormalities - Loss to follow-up or inability to complete the second-trimester scan - Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
Feasibility At 8 months after intervention Percent of completed transvaginal scans of fetal structural abnormality

Secondary

MeasureTime frame
Learning curve At 8 months after intervention Learning curve of first trimester anatomical scans between two different levels of proficiency operators ,Screening time At the end of intervention Screening time for first trimester anatomical scans between two different levels of proficiency operators ,Factors At the end of intervention Factors influencing the complete fetal anomalies scan in each group,LEarning curves At the end of intervention Fetal organ-specific learning curve between two different levels of proficiency operators

Countries

Thailand

Contacts

Public ContactPanithi Leesukon

Faculty of medicine, Ramathibodi hospital, Mahidol university

panithileesukon@gmail.com022011412

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026