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。我们开发了一种无创的方法来定量评估怀孕期间的子宫和子宫颈，该方法基于记录腹部表面的子宫电信号（子宫肌电图）和使用一种称为Collascope的光学装置测量光诱导宫颈胶原荧光（cervical LIF）。目前只有这两种仪器可以直接测量子宫和宫颈功能，这对评估妊娠状态至关重要。目前的方法，如子宫肌力计、超声和胎儿纤维连接蛋白，都不能做到这一点，所以目前产科医生的工具完全不足以对怀孕患者进行适当的评估。此申请是为了更新我们先前的拨款及相关的初步研究。三个研究建议使用子宫肌电图记录和宫颈LIF测量。具体的假设是：1)单独使用宫颈LIF和子宫肌电图变量，以及在多变量模型中结合使用时，可以准确预测产程和分娩。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)。子宫肌电图和宫颈LIF测量可用于确定宫颈功能不全患者的差异。具体目标是：1)提高使用LIF和EMG预测各种子宫/宫颈变量的能力。2)。评估子宫肌电图和宫颈LIF作为预测指标，并确定其与患者剖腹产和并发症发生率的相关性，特别是按种族亚组和感染。3)。描述宫颈功能不全患者的子宫肌电图和宫颈LIF。这些研究的潜在益处是巨大的，包括足月和早产的有效诊断、早产率的降低、孕产妇和围产期结局的改善、更好的治疗选择、剖宫产率的降低和产科研究的改善。在第二次也是最后一次重新提交中，我们回应了审稿人的批评，更新了数据，更正或修改了拨款的具体目的和文本。我们保留了妇产科母胎医学主任Gary Hankins博士参与该项目（见附录中Hankins博士的支持信）。

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).