Redefining Dystocia Diagnosis in Labor using Electrohysterography (RIDDLE)

描述(申请人提供)：与阴道分娩相比，剖腹产会导致更高的产妇发病率/死亡率和医疗费用。2009年，美国的剖腹产率为33%，而且还在上升。《分娩失败》(又名：难产)是非选择性(分娩期间)初次剖宫产的主要原因，直接或间接地占所有剖宫产的60%左右。对产程进展不佳的患者的管理重点是催产素的使用，假定子宫收缩的力量不足。然而，收缩的“力量”并不预示着难产。我们开发了一种非侵入性母胎监护仪，可以同时收集胎儿心电信号和子宫电活动(子宫肌电，EHG)。使用EHG信号生成子宫收缩活动的实时地形图，在一项初步的嵌套病例对照研究中，我们发现顺产后顺产的EHG的时空模式与因难产而行剖宫产者(p=0.003)和预测分娩方式(曲线下的ROC面积=0.91)显著不同。在这项赠款申请中，我们提出了一项更大规模的前瞻性队列研究，以更好地确定与难产剖宫产相关的特定EHG时空模式。我们将定义这些模式的测试表现特征，以区分那些进展为阴道分娩的妇女和那些没有进展的妇女。我们还建议评估预测难产的特定(异常)EHG模式是在宫颈扩张停止之前发生，还是仅在宫口停止扩张时发生。 扩张的可能性。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一项随机临床试验奠定基础，以评估这项技术作为一种工具的实用性，不仅可以降低剖宫产率，还可以减少与延长分娩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.