Cervix monitor for risk assessment of spontaneous preterm delivery

项目总结 早产是导致婴儿死亡和发病的主要原因。据估计，每年约有15 有数百万婴儿早产。在184个国家中，早产率从5%到18%不等。在……里面 在大多数国家，早产率在近几十年来有所上升，现在早产代表着 新生儿死亡的最常见原因。它是导致5岁以下儿童死亡的第二大直接原因 几年前。大多数早产都是自发发生的。因此，确定有自然发病风险的女性 早产(SPTD)仍然是一个至关重要的问题。过早软化、缩短和 宫颈扩张可被认为是其早期的机械故障，与早产有关。 出生。最近的临床研究结果证实了这样的假设，即宫颈弹性造影术可能提供有效的 预测早产的生物标志物。然而，在目前的临床实践中，宫颈的进展 成熟通常通过肉眼检查和数字检查进行主观监测。即使数量众多 与SPTD相关的风险因素在过去的几十年里已经被确定，准确预测的能力 何时分娩仍难以捉摸。新生物标志物的发现和验证；它们与 互补的标志物和已知的危险因素可以帮助确定导致SPTD的条件。在 第一阶段研究，一项对10名未怀孕和10名怀孕妇女进行的试点临床研究表明 宫颈监护仪(CM)α原型的测量性能和重复性令人满意 用触觉和超声换能器获取应力-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 在妊娠中期末收集宫颈定量数据的研究 β-CM设备原型。它将包括开发(预验证)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将 临床实践：一种紧凑，经济实惠，易于使用的测量宫颈弹性，长度， 评估SPTD的风险。

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.