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

这项拟议的研究将提炼并前瞻性地验证量化的有效性 超声(QUS)技术[QUS参数：颈部超声衰减系数(Atten)， 颈部超声背向散射系数(BSC)]，与超声(US)相比较-估计 宫颈长度(CL)，以确定自然早产(SPTB)的风险。早产(PTB) 定义为怀孕37周前出生(WKS GA)。在美国，每年超过44万人 婴儿早产，超过8万人早产(32周前)。PTB的后果 幸存者是严重的，可能是终生的，每年给社会造成300亿美元的损失，这一成本远远超过任何 重大成人诊断。预测女性罹患肺结核的风险在医学上具有挑战性，原因是：1)缺乏 早产的体征和症状，直到干预为时已晚；2)缺乏足够敏感的筛查 当干预可能有效时，可以足够早地发出sPTB风险信号的工具。自发早产 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有关 然而，无论肺结核的病因是什么，宫颈必须重塑以适应胎儿的通过。 我们的多学科调查团队开发了新颖的QUS技术，并展示了 有望成为一种广泛可用的早期检测肺结核的有效方法。QUS技术是一种 可以很容易地添加到当前的临床超声系统中的功能，从而缩短了从基础 科技创新翻译，提高女性临床护理水平。我们的初步研究表明， 有经验的sPTB在20周GA时的Atten显著低于20周时的足月女性，并且 在20周时，Atten比CL在24周时更准确地预测了sPTB。当ATTEN和CL度量都为 两者相结合，提高了对肺结核的预测能力。 我们的目标是：1)与单纯CL相比，更早和更准确地识别有sPTB风险的女性， 2)对孕激素治疗有效/无效的女性之间的差异。为了实现这些目标， 我们建议在两个时间点量化ATTEN、BSC和CL(20±2和24±2周GA；每项检查以 4周)，以确定sPTB的最大风险个体。我们的试点数据确定了20±2周的敏感时间 注意差异和24±2周对CL差异敏感。将招募三组妇女： 1)先行sPTB，2)20周短时CL，3)低危对照组。 中心假设：20±2周时颈椎Atten和BSC(单独或联合)优于24±2周的颈椎。 Wks用于检测sPTB的风险；此外，20±2和24±2周的ATTEN、BSC和CL合并时为偶数 能更好地检测肺结核的风险。

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.