QUS Technology for Identifying At-Risk Women for Spontaneous Preterm Birth

用于识别有自然早产风险的女性的 QUS 技术

• 批准号: 9212373
• 负责人: BARBARA L MCFARLIN
• 金额: $ 60.79万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-11 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9212373
• 关键词: 37 weeks gestation; Adult; Basic Science; Birth; Cervical; Cervix Uteri; Clinical; Control Groups; Data; Development; Diagnosis; Disabled Persons; Early Diagnosis; Early identification; Economic Burden; Economics; Effectiveness; Eligibility Determination; Etiology; Failure; Fetus; Goals; Healthcare Systems; High Risk Woman; Incidence; Individual; Infant; Intervention; Length; Life; Measurable; Measurement; Measures; Medical; Methods; Modeling; Perinatal mortality demographics; Pilot Projects; Predictive Value; Pregnancy; Premature Birth; Premature Labor; Progesterone; Progestins; Prospective Studies; Recruitment Activity; Reproducibility; Research; Risk; Risk Estimate; Signal Transduction; Signs and Symptoms; Societies; Survivors; Syndrome; System; Techniques; Technology; Testing; Time; Translations; Ultrasonography; Woman; Women' s Group; attenuation; clinical care; cost; design; experience; high risk; improved; innovation; multidisciplinary; novel; perinatal morbidity; predictive modeling; prevent; prospective; quantitative ultrasound; screening; tool; treatment responders

This proposed research will refine and prospectively validate the effectiveness of quantitative ultrasound (QUS) technology [QUS parameters: cervical ultrasound attenuation coefficient (ATTEN), cervical ultrasound backscatter coefficient (BSC)], when compared to ultrasound (US)-estimated cervical length (CL), to identify women at risk for spontaneous preterm birth (sPTB). Preterm birth (PTB) is defined as birth before 37 completed weeks' gestation (wks GA). Annually in the U.S., more than 440,000 infants are born preterm, and over 80,000 are born very preterm (prior to 32 wks). Consequences of PTB for survivors are severe, can be life-long and cost society $30 billion annually, a cost that far exceeds that of any major adult diagnosis. Predicting women at risk for sPTB has been medically challenging due to: 1) lack of signs and symptoms of preterm labor until intervention is too late, and 2) lack of sufficiently sensitive screening tools to signal sPTB risk early enough when an intervention would likely be effective. Spontaneous preterm labor is a syndrome associated with multiple etiologies of which only a portion may be associated with cervical insufficiency; however, regardless of the etiology of PTB, the cervix must remodel for passage of the fetus. Novel QUS technology has been developed by our multidisciplinary investigative team and shows promise for becoming a widely available and useful method for early detection of sPTB. QUS technology is a feature that can readily be added to current clinical ultrasound systems, thereby reducing the time from basic science innovation translation to improve clinical care of women. Our pilot studies show that women who experienced sPTB have a significantly lower ATTEN at 20 wks GA (relative to full-term women at 20 wks), and ATTEN at 20 wks more accurately predicts sPTB than CL at 24 wks. When both ATTEN and CL measures are combined, sPTB prediction is improved. Our goals are to identify: 1) women at risk for sPTB earlier and with better accuracy than with CL alone, and 2) differences between women who do/do not respond to progestogen therapy. To achieve these goals, we propose to quantify ATTEN, BSC & CL at two time points (20±2 & 24±2 wks GA; each exam separated by 4 wks) to identify individuals at greatest risk of sPTB. Our pilot data identified 20±2 wks to be sensitive to ATTEN differences and 24±2 wks to be sensitive to CL differences. Three groups of women will be recruited: 1) prior sPTB, 2) short CL at 20 wks, and 3) low-risk control group. Central hypothesis: Cervical ATTEN & BSC (alone or combined) at 20±2 wks are better than CL at 24±2 wks for detecting risk of sPTB; further, ATTEN, BSC & CL at 20±2 & 24±2 wks, when combined, are even better for detecting risk of sPTB.

这项提出的研究将完善并前瞻性地验证定量的有效性 超声（QUS）技术[QUS参数：宫颈超声衰减系数（ATTEN）， 与超声（US）相比，宫颈超声反向散射系数（BSC）] 宫颈长度（CL），以识别有赞助早产（SPTB）风险的女性。早产（PTB） 定义为在37个完成的几周妊娠（WKS GA）之前定义为出生。每年在美国，超过440,000 婴儿是早产的，超过80,000人出生的早产（32周之前）。 PTB的后果 幸存者很严重，可能是终身的，每年花费300亿美元，这一成本远远超过任何 主要的成人诊断。由于：1）缺乏 早产的迹象和症状，直到干预为时已晚，而2）缺乏足够敏感的筛查 当干预措施可能有效时，可以尽早发出SPTB发出信号的工具。自发早产 劳动是一种与多种病因相关的综合征，其中只有一部分与宫颈有关 功能不全；但是，无论PTB的病因如何，子宫颈都必须重塑以通过胎儿。 新颖的QUS技术是由我们的多学科调查团队开发的，并显示 有望成为早期检测SPTB的广泛可用和有用的方法。 QUS技术是 可以很容易地添加到当前临床超声系统的功能，从而减少了基本的时间 科学创新翻译以改善妇女的临床护理。我们的试点研究表明，女性 经验丰富的SPTB在20周GA时的Atten（相对于20周的完整女性）和 比在24 wks处更准确地预测SPTB的ATTEN更准确地预测SPTB。当Atten和CL措施是 合并的SPTB预测得到了改善。 我们的目标是确定：1​​）与单独使用CL相比，妇女面临SPTB的风险，并且具有更好的准确性， 2）对孕激素治疗不反应的妇女之间的差异。为了实现这些目标， 我们建议在两个时间点（20±2＆24±2 wks ga;每次考试分开）量化Atten，BSC＆CL 4周）确定具有SPTB风险最大的个体。我们的飞行员数据确定了20±2 wks对 ATTEN差异和24±2 wks对CL差异敏感。将招募三组妇女： 1）先前的SPTB，2）在20 wks时短Cl，3）低风险对照组。 中央假设：在20±2 WKS处的宫颈Atten＆BSC（单独或合并）在24±2时要好于Cl WKS检测SPTB的风险；此外，当组合时，Atten，BSC＆Cl在20±2和24±2 WKS时甚至是 更好地检测SPTB的风险。