Redefining Dystocia Diagnosis in Labor using Electrohysterography (RIDDLE)

描述（由申请人提供）：与阴道分娩相比，剖宫产导致更高的孕产妇发病率/死亡率和医疗费用。2009年，美国的剖宫产率为33%，而且还在不断增加。“无法在劳动中取得进展”（A.K.A.）难产）是非选择性（分娩期间）初次剖腹产的主要原因，并且直接或间接地占所有剖腹产分娩的约60%。对产程进展不良的患者的管理主要集中在催产素的管理上，假设子宫收缩的力量不足。然而，宫缩的“力量”并不能预测难产。我们开发了一种非侵入性母胎监测仪，可以收集胎儿心电图信号和子宫电活动（子宫电图，EHG）。使用EHG信号生成子宫收缩活动的实时地形图，在一项初步巢式病例对照研究中，我们证明了EHG的时空模式在阴道分娩时达到高潮的正常分娩进展的妇女与因难产而接受剖宫产的妇女之间存在显著差异（p=0.003）和预测的分娩方式（ROC曲线下面积=0.91）。在这项拨款申请中，我们提出了一个更大的，前瞻性队列研究，以更好地定义特定的时空模式的EHG与剖宫产分娩难产。我们将定义这些模式的测试性能特征，以区分阴道分娩的妇女和未阴道分娩的妇女。我们还建议评估是否特定的（异常）EHG模式预测难产之前停止宫颈扩张或仅发生在一旦有一个停止 扩张的。最后，我们将探索使用EHG模式作为预测的实时监视器 难产这些目标的实现将为随机临床试验奠定基础，以评估该技术作为一种工具的效用，不仅可以降低剖宫产率，还可以降低与分娩时间延长相关的孕产妇和新生儿发病率。

DESCRIPTION (provided by applicant): Compared to vaginal delivery, cesarean birth results in higher maternal morbidity/mortality and medical costs. In 2009, the cesarean rate in the United States was 33%, and it is still increasing. 'Failure to progress in labor' (a.k.a. dystocia)is the leading cause of non-elective (during labor) primary cesareans and directly or indirectly accounts for about 60% of all cesarean deliveries. Management of patients with poor labor progress focuses on the administration of oxytocin, presuming that the power of uterine contractions is inadequate. However, contraction "power" does not predict labor dystocia. We have developed a noninvasive maternal-fetal monitor that collects both fetal electrocardiographic signals and uterine electrical activity (electrohysterogram, EHG). Using the EHG signal to generate a real-time topographic map of uterine contractile activity, in a preliminary nested case-control study, we demonstrated that the spatiotemporal patterns of the EHG differed significantly between women with normal labor progress culminating in vaginal delivery and those who underwent cesarean for labor dystocia (p=0.003) and predicted mode of delivery (ROC area under the curve=0.91). In this grant application, we propose a larger, prospective cohort study to better define specific spatiotemporal patterns of the EHG that are associated with cesarean delivery for labor dystocia. We will define the test performance characteristics of those patterns that differentiate women who progress to vaginal delivery from those who do not. We propose to also evaluate whether specific (abnormal) EHG patterns predictive of dystocia precede cessation of cervical dilation or only occur once there is an arrest of dilation. Finally, we will explore the use of EHG patterns as a real-time monitor for predicting labor dystocia. Accomplishment of these aims will set the stage for a randomized clinical trial to evaluate the utility of this technology as a tool for not only decreasing the cesarean delivery rat but also reducing maternal and neonatal morbidities associated with protracted labor.