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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ahmet Demirci, MD
- 電話番号：+905418807091
- メール：ahmet.demirci@bilecik.edu.tr
研究場所
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Bilecik
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Bilecik、Bilecik、トルコ（Türkiye）、1000
- 募集
- Bilecik Training and Research Hospital
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コンタクト：
- Ahmet Demirci, MD
- 電話番号：+905418807091
- メール：ahmet.demirci@bilecik.edu.tr
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Agreement in Non-Stress Test Classification
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Agreement in Recommended Clinical Management
時間枠：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.
|
協力者と研究者
捜査官
- 主任研究者：Ahmet Demirci, MD、Bilecik Training and Research Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data will not be shared due to participant confidentiality and data protection considerations.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。