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 早产是婴儿死亡率和发病率的主要原因。据估计，每年大约15 百万婴儿天生的早产。在184个国家，早产率从5％到18％。在 大多数国家，早产率在近几十年来上升，现在早产代表 新生儿死亡率的最常见原因。这是最多5的儿童中第二大直接死亡原因 年龄。大多数早产出生。因此，确定有赞助者风险的妇女 早产（SPTD）仍然是至关重要的问题。过度软化，缩短和 子宫颈的扩张可能被视为其早期机械衰竭，与早产有关 生日。最近的临床发现证实了宫颈弹性图可以提供有效的假设 生物标志物预测早产。但是，在当前的临床实践中，子宫颈的进展 经常通过视觉检查和数字检查主观监测成熟。即使很多 在过去的几十年中已经确定了与SPTD相关的危险因素，准确预测的能力 何时发生劳动仍然难以捉摸。新生物标志物的发现和验证；他们的结合 完全标记和已知的风险因素可以帮助确定导致SPTD的条件。在 I阶段研究是一项针对10名非怀孕和10位孕妇的试点临床研究 基于子宫颈监视器（CM）的α-突变型的满意度测量表现和可重复性 关于通过触觉和超声传感器来获取应力应变数据。应力应变数据的可用性 允许计算子宫颈弹性和长度。第二阶段的主要目标是进行广泛的临床 在妊娠妊娠中期结束时收集子宫颈的定量数据的研究，并更新 β-型CM设备。它将包括开发（验证前）和临床验证研究，以测试 关于SPTD的CM预测能力的假设。该项目的长期目标是实现 临床实践，一种紧凑，成本效益且易于使用的设备，用于测量子宫颈弹性，长度， 并评估SPTD的风险。