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

用于实时产科应用的全自动子宫肌电图 (EMG)

• 批准号: 8312163
• 负责人: Jack McCrary
• 金额: $ 14.92万
• 依托单位: REPRODUCTIVE RESEARCH TECHNOLOGIES, L P
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-15 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8312163
• 关键词: Abdomen; Admission activity; Agreement; Benchmarking; Caring; Cervical; Cesarean section; Clinical; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Discipline of obstetrics; Early treatment; Electromyography; Exercise; Goals; Head; Health Care Costs; Healthcare; Healthcare Systems; Incidence; Intervention; Lead; Manuals; Measures; Medical; Methodology; Methods; Monitor; Morbidity - disease rate; Neonatal Mortality; Outpatients; Oxytocin; Patient Monitoring; Patients; Pharmaceutical Preparations; Phase; Pregnancy; Pregnancy Complications; Pregnant Women; Premature Birth; Premature Labor; Prevention; Process; Subgroup; Surface; System; Technology; Time; Tocolysis; Treatment Efficacy; Uterus; Wireless Technology; Woman; World Health Organization; clinical application; data acquisition; drug efficacy; effective therapy; fetal; improved; innovation; instrument; mortality; neonatal morbidity; perinatal health; pregnant; success; tool; treatment strategy

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. PUBLIC HEALTH RELEVANCE: According to a recent World Health Organization Bulletin (Bulletin of the World Health Organization 2010;88:31-38. doi: 10.2471/BLT.08.062554) on preterm birth: "...Preterm birth is a significant perinatal health problem across the globe, not ony in terms of associated mortality but also with regard to short- and long-term morbidity and financial implications for health-care systems." "Unfortunately, there are currently no effective diagnostic measures for preterm labor resulting in preterm birth, and no effective early interventions for prevention." The reason why there are no effective treatments for preterm labor and birth is because our ability to accurately diagnose it early and to monitor it while treatments are administered is very limited. New, promising real-time, automated uterine EMG technology proposed herein may change this. And this is just one of the many potential benefits that this system brings to obstetricians and their pregnant patients. This diagnostic equipment could also potentially: reduce cesarean section rates, reduce unnecessary treatments and admissions, improve clinicians' ability to monitor efficacy of drug treatments, identify true labor patients, reduce neonatal morbidity and mortality, improve overall pregnant patient healthcare management and reduce associated healthcare costs!

描述（由申请人提供）：早产的诊断是当今产科医生面临的最困难和最重要的任务。了解分娩何时开始以及预测何时开始对正常和复杂的妊娠都很重要。目前，没有有效的治疗早产。这种异常的最明显的原因是，没有客观的方式来评估怀孕的进展，通过步骤导致劳动。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，但在提高诊断和监测足月妊娠患者的能力方面也存在巨大的医疗成本影响，特别是在不正确地接纳未真正分娩的患者以及用诱导剂（如催产素）不正确地治疗足月患者方面。对于有分娩指征的临产和分娩但临床上未诊断为临产的妇女，实施适当的患者管理是极其困难的。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是临床上有用的评估子宫的状态。RRT已获得FDA批准用于子宫EMG患者监测方法（见附录）。然而，还没有一个小组在临床环境中开发和利用实时、自动化的子宫EMG诊断，用于足月和早产患者评估和药物治疗疗效监测。没有其他研究曾经在各种患者亚组和场景中将这样的诊断系统与临床参数进行头对头比较。RRT的总体目标是开发一种可销售和盈利的产品，帮助孕妇及其婴儿，挽救许多孕产妇和胎儿的生命。本文提出的创新性研究将允许我们用能够测量分娩的开始和进展的真正客观的设备来取代目前使用的粗糙的产科评估仪器，例如分娩力计（即“TOCO”），以及提供开发针对妊娠并发症的更好的治疗策略的工具。 公共卫生相关性：根据最近的世界卫生组织公报（Bulletin of the World Health Organization 2010;88：31-38. doi：10.2471/BLT.08.062554）关于早产：“.早产是地球仪的一个重大围产期健康问题，不仅是相关死亡率，而且是短期和长期发病率以及对保健系统的财政影响。”“不幸的是，目前还没有有效的诊断措施来诊断导致早产的早产，也没有有效的早期干预措施来预防。“早产和分娩没有有效治疗方法的原因是，我们有能力在早期准确诊断早产，并在治疗过程中监测早产。 管理是非常有限的。本文提出的新的、有前途的实时自动子宫EMG技术可能会改变这一点。这只是这个系统给产科医生和他们的孕妇带来的众多潜在好处之一。这种诊断设备还可能：降低剖宫产率，减少不必要的治疗和入院，提高临床医生监测药物治疗效果的能力，识别真正的分娩患者，降低新生儿发病率和死亡率，改善整体妊娠患者的医疗保健管理，降低相关的医疗保健成本！