A new non-invasive technology to diagnose preterm labor

描述（由申请人提供）：早产占美国所有出生的12%，被确定为围产期发病率和死亡率的主要原因。尽管医学和技术进步，但近年来早产的发生率并没有下降，对早产子宫收缩发生和传播的生理机制的认识仍然不完整。目前的子宫监测方法阳性预测值较低，缺乏研究和计划适当治疗干预措施的敏感性。我们建议使用一种名为SARA （Squid Array for Reproductive Assessment）的无创技术设备，通过无创记录子宫平滑肌电活动对应的磁场（magnetomography - mmg）来研究子宫收缩的生理机制。SARA被设计成用151个单独的传感器覆盖整个母体腹部。通过从多个点同时记录子宫MMG，我们获得了在SARA之前无法获得的时空信息。它的位置在劳动和分娩单位提供独特的访问早产患者。该阵列设计为子宫平滑肌细胞中动作电位的激发和传播所引起的子宫电活动的开始和传播提供了无创磁记录。SARA的详细时空分辨率可以确定局部激活区域、传播速度和方向，以及活动的传播与距离的关系。这些数据将用于定义导致有组织的子宫收缩的生理步骤，从而为准确预测主动分娩开始的方法的发展提供基础。对子宫电生理活动的开始和传播的新见解也可能为抑制早产和引产提供创新的方法。拟建项目的具体目标是：1。确定是否可以使用连续子宫MMG测量来预测长时间胎膜早破患者的分娩。2. 确定子宫MMG记录是否可用于辨别假早产和真早产。此外，我们计划将MMG的预测能力与早产的标准测试进行比较。

DESCRIPTION (provided by applicant): Premature delivery accounts for 12% of all births in the United States and is identified as the leading cause of perinatal morbidity and mortality. Despite advancements in medicine and technology, the incidence of preterm birth has not decreased in recent years and knowledge of the physiological mechanism of the onset and propagation of uterine contractions of preterm labor remains incomplete. Current uterine monitoring methodologies have low positive predictive values and lack the sensitivity to study and plan appropriate therapeutic interventions. We propose to use a non-invasive technology device called SARA (Squid Array for Reproductive Assessment) to study the physiological mechanism of uterine contractions by non-invasively recording magnetic fields (Magnetomyography-MMG) corresponding to electrical activity of the uterine smooth muscle. SARA was designed to cover the entire maternal abdomen with 151 individual sensors. By simultaneously recording uterine MMG from multiple points, we gain access to spatial-temporal information unattainable prior to SARA. Its location within the labor and delivery unit provides unique access to preterm patients. The array design provides non-invasive magnetic recording of the initiation and propagation of uterine electrical activity resulting from excitation and propagation of action potentials in uterine smooth muscle cells. The detailed spatial-temporal resolution of SARA can determine regions of localized activation, propagation velocity and direction, and spread of activity as a function of distance. This data will be used to define physiological steps leading to organized uterine contractions, thus providing the basis for the development of a methodology to accurately predict the onset of active labor. New insight into the initiation and propagation of uterine electrophysiological activity may also provide innovative approaches toward suppression of preterm labor and induction of labor. The specific aims of the proposed project are: 1. Determine if serial uterine MMG measurements can be used to predict the onset of labor in patients with prolonged premature rupture of membranes. 2. Determine if uterine MMG recordings can be used to discern false preterm labor from true preterm labor. In addition, we plan to compare the predictive power of MMG to standards tests for pre-term labor. PUBLIC HEALTH RELEVANCE:A new non-invasive technology to better diagnosis of preterm labor which can lead to development of strategies that can prevent or control preterm labor thereby reducing the incidence of preterm birth.