Artificial Intelligence, Obstetricians, and Midwives in Non-Stress Test Interpretation
Diagnostic Accuracy of Artificial Intelligence, Obstetricians, and Midwives in Non-Stress Test Interpretation: A Prospective Comparative Study
This prospective observational study aims to evaluate and compare the interpretation of antenatal non-stress tests (NSTs) by three artificial intelligence models, three obstetricians, and three midwives.
A total of 300 NST recordings obtained during routine antenatal care will be collected and prepared in PDF format. The recordings will be distributed to the evaluators, who will independently assess NST reactivity and recommend appropriate clinical management within two weeks.
Two perinatologists will independently evaluate the NST recordings to establish the reference standard. In cases of disagreement, a third perinatologist will be consulted to determine the final reference assessment.
The study will compare the diagnostic performance, agreement with the reference standard, and inter-rater agreement among artificial intelligence models, obstetricians, and midwives.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahmet Demirci, MD
- Número de teléfono: +905418807091
- Correo electrónico: ahmet.demirci@bilecik.edu.tr
Ubicaciones de estudio
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Bilecik
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Bilecik, Bilecik, Turquía (Türkiye), 1000
- Reclutamiento
- Bilecik Training and Research Hospital
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Contacto:
- Ahmet Demirci, MD
- Número de teléfono: +905418807091
- Correo electrónico: ahmet.demirci@bilecik.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Pregnant women undergoing antenatal non-stress testing (NST) at the study center will constitute the study population. A total of 300 NST recordings will be collected and independently evaluated by three artificial intelligence models, three obstetricians, and three midwives. Two perinatologists will independently assess the recordings to establish the reference standard. In cases of disagreement, a third perinatologist will be consulted to determine the final reference assessment.
Descripción
Inclusion Criteria:
- Gestational age of 34+0 weeks or greater
- Singleton pregnancy undergoing routine antenatal follow-up
- Availability of an interpretable NST recording with a minimum duration of 20 minutes
- Complete clinical and demographic data
- Provision of written informed consent
Exclusion Criteria:
- Multiple pregnancy
- Major fetal congenital anomaly
- Technically uninterpretable NST recording
- NST recording shorter than 20 minutes
- Incomplete clinical data
- Refusal to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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Pregnant Women Undergoing Non-Stress Testing
Pregnant women undergoing non-stress testing (NST) as part of routine antenatal care. The NST recordings will be independently evaluated by artificial intelligence models, obstetricians, and midwives, and their assessments will be compared with the reference evaluation. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Agreement in Non-Stress Test Classification
Periodo de tiempo: Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
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Agreement between artificial intelligence models, obstetricians, and midwives in classifying non-stress tests (NSTs) as reactive or non-reactive will be assessed against a reference standard established by two independent perinatologists. In cases of disagreement, a third perinatologist will be consulted to determine the final reference classification. Inter-rater agreement among the evaluator groups will also be assessed. |
Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Agreement in Recommended Clinical Management
Periodo de tiempo: Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
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Agreement between artificial intelligence models, obstetricians, and midwives regarding recommended clinical management following NST interpretation will be assessed against a reference standard established by two independent perinatologists. Disagreements will be resolved through consultation with a third perinatologist. |
Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ahmet Demirci, MD, Bilecik Training and Research Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- NST-AI-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared due to participant confidentiality and data protection considerations.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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