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

孕妇经常会经历早产子宫收缩，但目前的评估方法 不能快速准确地诊断真正的劳动与假劳动。目前，这些评价 “临产先兆”平均4小时，而且往往导致诊断不正确。错误诊断 导致不能给予预防早产儿并发症治疗或导致长期、昂贵的 和不必要的住院治疗长时间的评估会导致效率低下，并延迟启动经过验证的治疗。 在美国，由于早产而导致的流产每年造成100 B美元的医疗费用。 目前的方法产生许多假阳性和假阴性诊断。目前的诊断方法 早产患者的真实分娩敏感性仅为40 - 60%，特异性为60 - 85%。每个假阴性 结果是错过了在出生前用类固醇治疗的机会。缺少类固醇会增加肺部和 早产儿的脑部并发症每一个假阳性都是一个不恰当的入院和治疗。 几十年来，人们已经认识到需要更迅速、更准确地诊断分娩状态， 以前的尝试只取得了有限的成果。PreTeL的劳动状态监视器提供主要 使用革命性的技术方法进行改进。这种新方法源于对 人类子宫如何产生收缩，然后发现如何确定单个收缩是否 是强还是弱。核心技术（子宫肌电）是完善的，但三个关键的创新是 补充说首先，方向性EMG传感器，称为区域传感器，用于定位源自于神经上的信号。 其次，基于同步化程度或收缩的时间来分析局部收缩。 子宫上不同位置的信号;第三，区域传感器揭示了发生在子宫上的独特EMG信号。 之间的矛盾和虚假劳动的特点。真假分娩的诊断基于两个方面 索引，一个索引用于同步，另一个用于假分娩信号。 分娩状态监测器旨在诊断真正的劳动和假劳动后，只有1小时的 该方法具有更高的灵敏度和特异性，比目前的方法。第二阶段的目标1 应用程序中，临床试验产生的训练数据，确定两个指数的阈值，优化 分娩状态监视器的诊断性能。在目标2中，指标得到验证。缩短时间 评估所需的时间缩短1小时，敏感性和特异性提高10%， 成本为6.63亿美元。该提案将提供数据，以全面计划关键试验，以支持FDA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.