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

这项拟议的研究将完善和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）， 颈部超声背向散射系数（BSC）]，与超声（US）估计值相比 宫颈长度（CL），以识别有自发性早产（sPTB）风险的女性。早产（PTB） 定义为在妊娠37周（wks GA）之前出生。每年在美国，44万余 婴儿早产，80，000多名婴儿早产（32周之前）。PTB的后果 幸存者是严重的，可能是终身的，每年给社会造成300亿美元的损失，这一成本远远超过任何 成人诊断。预测处于sPTB风险中的女性在医学上具有挑战性，因为：1）缺乏 早产的体征和症状，直到干预为时已晚，以及2）缺乏足够敏感的筛查 在干预措施可能有效时及早发出sPTB风险信号的工具。自发的预产期前 分娩是一种与多种病因相关的综合征，其中只有一部分可能与宫颈癌有关。 然而，无论PTB的病因如何，子宫颈必须重塑以使胎儿通过。 我们的多学科调查团队开发了新颖的QUS技术， 有望成为sPTB早期检测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，从而减少从基本 科学创新转化为改善妇女临床护理。我们的初步研究表明， 有经验的sPTB在GA 20周时的ATTEN显著较低（相对于20周时的足月女性），并且 20周时的ATTEN比24周时的CL更准确地预测sPTB。 组合后，sPTB预测得到改善。 我们的目标是识别：1）比单独使用CL更早且更准确地发现sPTB风险的女性， 和2）对孕激素治疗有反应/无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（GA 20±2和24±2周;每次检查间隔为 4周），以确定sPTB风险最大的个体。我们的初步数据确定了20±2周对 ATTEN差异和24±2周对CL差异敏感。将招募三组妇女： 1)既往sPTB，2）20周时的短CL，3）低风险对照组。 中心假设：20±2周时颈椎ATTEN和BSC（单独或联合）优于24±2周时的CL 此外，当组合时，在20±2和24±2周的ATTEN、BSC和CL甚至 更好地检测sPTB的风险。

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.