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

用于诊断早产患者真假临产的临产状态监测仪

基本信息

批准号：
10484554
负责人：
ROGER C. YOUNG
金额：
$ 137.55万
依托单位：
PRETEL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-26 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10484554
关键词：
37 weeks gestation Address Admission activity Area Birth Brain Cervix Uteri Characteristics Clinical Trials Data Development Devices Diagnosis Diagnostic Diagnostic Errors Diagnostic Sensitivity Evaluation Failure Fetal Lung Freezing Frequencies Gestational Age Goals Gold Grouping Health Care Costs Hospitalization Hour Human Individual Instruction Interview Knowledge Lead Location Lung Manuals Measures Methods Monitor Neonatal Pain Patients Performance Phase Pregnant Women Premature Infant Premature Labor Protocols documentation Provider Questionnaires Reporting Risk Sensitivity and Specificity Signal Transduction Specificity Steroid therapy Steroids Study Subject Techniques Technology Testing Time Training Uterine Contraction Uterus Woman Work accurate diagnosis antenatal base cohort cost data acquisition design diagnosis standard diagnostic tool experience improved indexing innovation innovative technologies knowledge of results lung development neonatal outcome neonate new technology novel novel strategies obstetric care premature prevent prophylactic respiratory sensor

项目摘要

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.

孕妇经常经历早产子宫收缩，但是当前的评估方法无法快速准确地诊断真正的人工与虚假劳动。目前，这些评估 “威胁性劳动”平均4小时，而导致的诊断经常是不正确的。不正确的诊断导致无法管理预防早产并发症或导致冗长，昂贵的疗法和不必要的住院。 Long evaluations create inefficiencies and delays starting proven therapies. 在美国，由于早产劳动而导致的交付是$ 10 B的年度医疗保健费用。当前方法会产生许多假阳性和假阴性诊断。当前方法诊断早产患者的真正劳动，其灵敏度仅为40-60％，特异性为60-85％。每个假负结果是在出生前用类固醇治疗的机会。缺失类固醇会增加肺的风险和早产婴儿的大脑并发症。每个假阳性都是不适当的入院和治疗。数十年来，需要更快，准确地诊断劳动力状况的需求已得到认可，但是以前的尝试仅产生适度的收益。 Pretel的工党状况监测仪提供了专业使用革命性的技术方法进行改进。这种新方法源于对人子宫如何产生宫缩，然后发现如何确定是否单个收缩坚强或软弱。核心技术（子宫EMG）已经建立了良好的，但三个关键创新是额外。首先，定向EMG传感器（称为区域传感器）用于定位起源于子宫墙；其次，根据同步程度或时间安排分析本地收缩子宫不同位置的信号；第三，区域传感器揭示了出现独特的EMG信号宫缩和人物之间的虚假劳动。根据两个索引，一个同步索引，另一个用于虚假劳动信号的索引。劳工状况监测仪旨在仅1小时后诊断真正的劳动和虚假劳动力评估比当前方法具有更高的灵敏度和特异性。在此阶段的目标1中应用，临床试验产生培训数据，以识别两个指数的阈值，以优化人工状况监测仪的诊断性能。在AIM 2中，索引得到了验证。 Shortening the time 通过1小时评估所需的敏感性和特异性需要10％，将减少年度医疗保健成本降低663美元。该提案将提供数据以完全计划关键试验以支持FDA批准。