Assessment of Uterine Contractility and Cervical Ripening During Pregnancy

描述(由申请人提供)：怀孕期间与分娩相关的问题是医生最重要的问题之一。这些问题包括足月和早产的诊断，以及与分娩相关的治疗。我们开发了一种非侵入性的方法来定量评估怀孕期间的子宫和宫颈，其基础是记录来自腹部表面的子宫电信号(子宫肌电)和使用名为Colascope的光学设备测量光诱导宫颈胶原荧光(CING LIF)。目前，只有这两种装置可以直接测量子宫和宫颈功能，这对评估怀孕状态至关重要。目前的方法，如共功率法、超声波和胎儿纤维连接蛋白，不能做到这一点，所以目前产科医生的工具完全不足以正确评估怀孕患者。这项申请是为了续期我们之前的资助和相关的初步研究。建议进行三项研究，使用子宫肌电记录和宫颈LIF测量。具体假设如下：1)单独使用宫颈LIF和子宫肌电变量，并结合多变量模型，可以准确预测分娩和分娩。使用子宫肌电图和宫颈LIF测量可以预测分娩并发症和剖腹产的可能性，以确定高危人群。3.)子宫肌电和宫颈LIF测量可以用来确定宫颈功能不全患者的差异。具体目标是：1.使用LIF和EMG提高各种子宫/宫颈变量的预测能力。2.)评估子宫肌电和宫颈LIF作为预测指标，并确定它们与剖腹产和患者并发症发生率的相关性，特别是按种族和感染分组。3.)宫颈功能不全患者的子宫肌电和宫颈LIF特征。这些研究的潜在好处是巨大的，包括对足月和早产的有效诊断，降低早产率，改善母婴结局，更好的治疗选择，降低剖宫产率，以及产科研究的改进。在第二次也是最后一次的重新提交中，我们回应了评审员的批评，更新了数据，并更正或修改了赠款的具体目标和文本。我们在该项目中保留了妇产科母胎医学部主任Gary Hankins博士(见附录中Hankins博士的支持函)。

DESCRIPTION (provided by applicant): Problems associated with labor during pregnancy are some of the most important issues for physicians. These problems include diagnosis of term and preterm labor, and treatments associated with labor. We have developed noninvasive methods to quantitatively evaluate the uterus and cervix during pregnancy based on recording of uterine electrical signals from the abdominal surface (uterine EMG) and measurement of light induced cervical collagen fluorescence (cervical LIF) with an optical device called the Collascope. Only these two devices can currently give a direct measure of uterine and cervical function, which is critical for assessing the state of pregnancy. Current methods, such as tocodynamometery, ultrasound, and fetal fibronectin, cannot do this, so current tools for obstetricians are completely inadequate for proper evaluation of pregnant patients. This application is to renew our previous grant and the associated initial studies. Three studies are proposed using uterine EMG recordings and cervical LIF measurements. The specific hypotheses are: 1.) Labor and delivery can be accurately predicted using cervical LIF and uterine EMG variables individually, and when combined in a multivariate model 2.) Parturition complications and c-section likelihood can be forecast using uterine EMG and cervical LIF measurements to identify high-risk groups. 3.) Uterine EMG and cervical LIF measurements can be used to determine differences in patients with cervical insufficiency. The specific aims are to: 1.) Improve predictive capability of various uterine/cervical variables using LIF and EMG. 2.) Assess uterine EMG and cervical LIF as predictive indicators, and to determine their correlation with c-section and complication incidence in patients, specifically by ethnic subgroups and with infection. 3.) Characterize uterine EMG and cervical LIF in patients with cervical insufficiency. The potential benefits of these studies are substantial, and include effective diagnosis of term and preterm labor, reduction in rate of preterm labor, improvement in maternal and perinatal outcome, better selection of treatments, a decrease in cesarean section rate, and improvement in obstetrical research. In this second and final resubmission, we have responded to the reviewer's critiques, updated the data, and corrected or amended the specific aims and text of the grant. We have maintained Dr. Gary Hankins, Chief of Division of Maternal-Fetal Medicine, Department of Ob/Gyn, in the project (see Dr. Hankins' letter of support in the Appendix).