- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07916090
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.
Studieöversikt
Status
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Ahmet Demirci, MD
- Telefonnummer: +905418807091
- E-post: ahmet.demirci@bilecik.edu.tr
Studieorter
-
-
Bilecik
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Bilecik, Bilecik, Turkiet (Türkiye), 1000
- Rekrytering
- Bilecik Training and Research Hospital
-
Kontakt:
- Ahmet Demirci, MD
- Telefonnummer: +905418807091
- E-post: ahmet.demirci@bilecik.edu.tr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Agreement in Non-Stress Test Classification
Tidsram: Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Agreement in Recommended Clinical Management
Tidsram: Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
|
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.
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Ahmet Demirci, MD, Bilecik Training and Research Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NST-AI-2026-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Individual participant data will not be shared due to participant confidentiality and data protection considerations.
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