Fully automating uterine electromyography (EMG) for real-time obstetric applicati

描述（由申请人提供）：早产诊断是当今产科护理中医生面临的最困难和最重要的任务。知道什么时候开始分娩以及预测什么时候开始分娩对正常和复杂的怀孕都很重要。目前，尚无有效的治疗早产的方法。这种异常最明显的原因是没有客观的方法来评估妊娠的进展，通过步骤导致分娩。因此，如果没有准确诊断分娩的方法，治疗可能永远不会改善。虽然早产对妇产科有重大影响，但在提高足月妊娠患者的诊断和监测能力方面，也存在巨大的医疗成本后果，特别是在错误地接纳非真正分娩的患者方面，以及错误地使用诱导剂（如催产素）治疗足月患者。对有分娩指征的临产妇女进行适当的病人管理是极其困难的，但她们没有临床诊断为临产。我们的初步研究提供了令人信服的证据，从腹部表面记录肌电图活动在临床上评估子宫状态是有用的。RRT已经获得FDA批准用于子宫肌电图患者监测方法（见附录）。然而，目前还没有小组开发和利用实时、自动子宫肌电图诊断在临床环境中进行足月和早产儿患者评估和药物治疗效果监测。没有其他研究将这种诊断系统与临床参数在各种患者亚组和情况下进行过面对面的比较。RRT的总体目标是开发一种可销售和有利可图的产品，以帮助孕妇及其婴儿，并挽救许多孕产妇和胎儿的生命。本文提出的创新研究将使我们能够取代目前使用的粗糙的产科评估工具，如生育测力计(即：“TOCO”)，具有真正客观的设备，能够测量分娩的开始和进展，并为制定更好的妊娠并发症治疗策略提供工具。

DESCRIPTION (provided by applicant): Diagnosis of preterm labor is the most difficult and important task facing medical practitioners in maternity care today. Knowing when labor has begun as well as predicting when it will start is important for both normal and complicated pregnancies. Presently, there is no effective treatment of preterm labor. The most obvious reason for this anomaly is that there is no objective manner to evaluate the progression of pregnancy through steps leading to labor. Therefore, without methods to accurately diagnosis labor, treatment may never improve. Although preterm labor has major implications in OB-GYN, there are also tremendous healthcare cost ramifications in improving the ability to diagnose and monitor term pregnant patients, especially in regard to incorrectly admitting patients who are not in true labor, as well as incorrectly treating term patients with induction agents (such as oxytocin). It is extremely difficult to exercise proper patient management for women who present to labor and delivery with indications for delivery, but who are not clinically diagnosed as being in labor. Our preliminary studies provide convincing evidence that recording of EMG activity from the abdominal surface is clinically useful in evaluating the state of the uterus. RRT has already received FDA approval for uterine EMG patient monitoring methodology (See Appendix). However, no group has yet developed and utilized real-time, automated uterine EMG diagnostics in a clinical setting for term and preterm patient assessment and drug treatment efficacy monitoring. No other study has ever compared such a diagnostic system to clinical parameters head-to-head, in a variety of patient subgroups and scenarios. The overall goal of RRT is to develop a marketable and profitable product that will help pregnant women and their babies, and save many maternal and fetal lives. The innovative studies proposed herein will allow us to replace crude obstetric assessment instruments presently used, such as tocodynamometer (i.e. "TOCO"), with a truly objective device capable of measuring the onset and progress of labor, as well as providing a tool to develop better treatment strategies for pregnancy complications.