Labor Status Monitor for diagnosing True versus False Labor in preterm patients

孕妇经常经历早产子宫收缩，但目前的评估方法 不能快速准确地诊断真实劳动与虚假劳动。目前，这些评价是针对 “先兆分娩”平均为4小时，结果诊断错误的频率太高了。错误的诊断 导致未能实施预防早产并发症的治疗或导致漫长、昂贵的治疗 以及不必要的住院治疗。长时间的评估会造成低效和延迟启动经过验证的疗法。 在美国，由于早产导致的分娩造成了每年100亿美元的医疗成本。 目前的方法产生了许多假阳性和假阴性诊断。当前诊断方法 在早产患者中，真分娩的敏感性仅为40-60%，特异性为60-85%。每个假阴性 结果是错失了在出生前使用类固醇治疗的机会。缺少类固醇会增加患肺癌和 早产儿的脑部并发症。每一次假阳性都是不适当的入院和治疗。 几十年来，人们已经认识到需要更快、更准确地诊断分娩状况，但 之前的尝试只取得了一定的收益。Pretel的劳动状况监视器提供主要 使用革命性的技术方法进行改进。这种新方法源于对以下问题的新认识 人类子宫如何产生宫缩，然后发现如何确定个体宫缩是否 是强是弱。核心技术(子宫肌电)已经很成熟了，但有三项关键创新 添加了。首先，方向性肌电传感器，称为区域传感器，用于定位起源于 第二，根据同步化程度或子宫收缩的时间来分析局部收缩。 子宫上不同位置的信号；第三，区域传感器显示了发生在子宫上的独特的肌电信号 在宫缩之间，并以虚假劳动为特征。真与假分娩的诊断基于两个 索引，一个索引用于同步，另一个索引用于错误的人工信号。 劳动状态监视器设计为仅在分娩1小时后诊断真劳动和假劳动 与现有方法相比，该方法具有更高的敏感性和特异性。在此第二阶段的目标1中 应用程序，临床试验产生识别优化的两个指数的阈值的训练数据 人工状态监视器的诊断性能。在目标2中，对指标进行了验证。缩短时间 评估所需时间缩短1小时，敏感度和特异度提高10%将减少每年的医疗保健 成本减少6.63亿美元这项提案将提供数据，以全面计划关键试验，以支持FDA的批准。

Pregnant women often experience preterm uterine contractions, but current methods of evaluation cannot quickly and accurately diagnose True Labor versus False Labor. Currently, these evaluations for “threatened labor” average 4 hours, and too frequently the resulting diagnosis is incorrect. Incorrect diagnoses lead to failure to administer therapies that prevent complications of prematurity or lead to lengthy, expensive and needless hospitalizations. Long evaluations create inefficiencies and delays starting proven therapies. Deliveries due to preterm labor are responsible for $10 B in annual healthcare costs in the US. Current methods produce many false positive and false negative diagnoses. Current methods diagnose True Labor in preterm patients with a sensitivity of only 40-60% and specificity of 60-85%. Each false negative result is a missed opportunity to treat with steroids before birth. Missing steroids increases the risk of lung and brain complications for premature babies. Each false positive is an inappropriate admission and treatment. The need to diagnose labor status more rapidly and accurately has been recognized for decades, but previous attempts have yielded only modest gains. PreTeL’s Labor Status Monitor provides major improvements using a revolutionary technological approach. This new approach arose from new knowledge of how the human uterus creates contractions, and then discovering how to determine if individual contractions are strong or weak. The core technology (uterine EMG) is well-established, but three key innovations are added. First, directional EMG sensors, called Area Sensors, are used to localize signals that originate on the uterine wall; Second, the local contractions are analyzed based on the degree of synchronization, or timing of the signals at different locations on the uterus; Third, Area Sensors revealed a unique EMG signal that occurs between contractions and characterizes False Labor. True versus False Labor is diagnosed based on two indices, one index for synchronization and the other for the False Labor signals. The Labor Status Monitor is designed to diagnose both True Labor and False Labor after only 1 hour of evaluation and with a higher sensitivity and specificity than current methods. In Aim 1 of this Phase II application, a clinical trial produces training data that identifies the thresholds of the two indices that optimize the diagnostic performance of the Labor Status Monitor. In Aim 2, indices are validated. Shortening the time needed for evaluation by 1 hour and improving sensitivity and specificity by 10% will reduce annual health care costs by $663 M. This proposal will provide data to fully plan the pivotal trial to support FDA approval.