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Artificial Intelligence, Obstetricians, and Midwives in Non-Stress Test Interpretation

2026年10月31日 更新者:Ahmet Demirci、Bilecik Seyh Edebali Universitesi

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.

研究概览

研究类型

观察性的

注册 (估计的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Agreement in Non-Stress Test Classification
大体时间: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.

次要结果测量

结果测量
措施说明
大体时间
Agreement in Recommended Clinical Management
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ahmet Demirci, MD、Bilecik Training and Research Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月1日

初级完成 (估计的)

2026年11月15日

研究完成 (估计的)

2026年11月15日

研究注册日期

首次提交

2026年10月22日

首先提交符合 QC 标准的

2026年10月31日

首次发布 (实际的)

2026年11月4日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年10月31日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • NST-AI-2026-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared due to participant confidentiality and data protection considerations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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