Cervix monitor for risk assessment of spontaneous preterm delivery

宫颈监测仪用于评估自然早产的风险

• 批准号: 9902476
• 负责人: Vladimir Egorov
• 金额: $ 69.42万
• 依托单位: ADVANCED TACTILE IMAGING, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-22 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9902476
• 关键词: 5 year old; Algorithmic Software; Biological Markers; Breast; Cause of Death; Certification; Cervical; Cervix Uteri; Child; Clinical; Clinical Research; Computer software; Country; Coupling; Data; Development; Devices; Effectiveness; Elasticity; Electromagnetics; Failure; Female; Goals; Grant; Imaging Device; Imaging technology; Infant; Infant Mortality; Legal patent; Length; Measurement; Mechanics; Modulus; Monitor; Muscle; Neonatal Mortality; Outcome; Pelvic floor structure; Performance; Phase; Pregnancy; Pregnant Women; Premature Birth; Procedures; Prostate; Reporting; Reproducibility; Research; Risk; Risk Assessment; Risk Factors; Safety; Second Pregnancy Trimester; Secure; Software Design; Stress; System; Tactile; Test Result; Testing; Time; TimeLine; Ultrasonic Transducer; Ultrasonography; United States National Institutes of Health; Update; Vagina; Validation; Visual; Wireless Technology; Woman; base; biomaterial compatibility; clinical development; clinical practice; cost effective; design; diagnostic accuracy; digital; elastography; imaging system; infant morbidity; interest; monitoring device; premature; prototype; sensor; software development; transmission process; usability; validation studies

PROJECT SUMMARY Preterm delivery is a leading cause of infant mortality and morbidity. It is estimated that annually about 15 million infants are born preterm. Across 184 countries, the rate of preterm birth ranges from 5% to 18%. In most countries, the rate of preterm birth has risen in the recent decades, and now preterm birth represents the most common cause of neonatal mortality. It is the second largest direct cause of death in children up to 5 years of age. Most preterm births occur spontaneously. Therefore, identifying women at risk for spontaneous preterm delivery (SPTD) remains an issue of paramount importance. Premature softening, shortening and dilation of the cervix, which may be considered as its early mechanical failure, is associated with the preterm birth. Recent clinical findings confirm the hypothesis that cervical elastography may provide effective biomarkers to predict preterm delivery. However, in the current clinical practice, the progress of the cervix ripening is often monitored subjectively by visual inspection and digital examination. Even though numerous risk factors associated with SPTD have been identified in the previous decades, the ability to accurately predict when labor will occur remains elusive. The discovery and validation of new biomarkers; their combination with complementary markers and the known risk factors could help identify the conditions leading to SPTD. In the Phase I research, a pilot clinical study with 10 non-pregnant and 10 pregnant women has demonstrated satisfactory measurement performance and reproducibility of the α-prototype of the Cervix Monitor (CM) based on the acquisition of stress-strain data by tactile and ultrasound transducers. Availability of stress-strain data allowed computation of cervix elasticity and length. The main goal of Phase II is to conduct extensive clinical studies to collect quantitative data on the cervix at the end of the second trimester of pregnancy with updated β-prototype CM device. It will include a development (pre-validation) and clinical validation studies to test the hypotheses about the CM predictive capability for SPTD. The long-term objective of the project is to bring into clinical practice a compact, cost-effective and easy-to-use device for measurement of cervix elasticity, length, and assessing the risk of SPTD.

项目摘要 早产是婴儿死亡和发病的主要原因。据估计，每年约有15 100万婴儿早产。在184个国家中，早产率从5%到18%不等。在 在大多数国家，早产率在近几十年来有所上升，现在早产代表了 最常见的新生儿死亡原因。它是5岁以下儿童死亡的第二大直接原因 岁的大多数早产是自发发生的。因此，识别有自发性流产风险的女性， 早产（SPTD）仍然是最重要的问题。过早软化、缩短和 子宫颈扩张可能被认为是其早期机械性衰竭， 出生最近的临床研究结果证实了这一假设，即颈部弹性成像可以提供有效的 生物标志物来预测早产。然而，在目前的临床实践中，宫颈癌的进展 通常通过目视检查和数字检查来主观地监测成熟。尽管众多 在过去的几十年中，与SPTD相关的风险因素已经被确定， 何时分娩仍是未知数新生物标志物的发现和验证;它们与 互补标志物和已知的危险因素可以帮助识别导致SPTD的条件。在 第一阶段研究，一项对10名非孕妇和10名孕妇进行的初步临床研究表明， 基于CERTIFICATE Monitor（CM）的α原型的测量性能和再现性令人满意 通过触觉和超声波传感器获取应力应变数据。应力应变数据的可用性 允许计算宫颈弹性和长度。第二阶段的主要目标是进行广泛的临床试验， 研究，以收集有关子宫颈的定量数据，在妊娠中期结束时， β原型CM装置。它将包括开发（预验证）和临床验证研究，以测试 关于CM对SPTD的预测能力的假设。该项目的长期目标是使 临床实践一种用于测量子宫颈弹性，长度， 评估SPTD的风险。