Identifying the precursor to oxytocin-induced uterine tachysystole by monitoring with uterine EMG

通过子宫肌电图监测来识别催产素诱导的子宫收缩过速的前兆

• 批准号: 9752933
• 负责人: ROGER C. YOUNG
• 金额: $ 20.3万
• 依托单位: PRETEL, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2020-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9752933
• 关键词: Admission activity; Appearance; Businesses; Categories; Cesarean section; Characteristics; Clinical; Computer software; Contracts; Data; Data Set; Depressed mood; Device or Instrument Development; Discipline of obstetrics; Dose; Electromyography; Emergency Situation; Exposure to; Fetal Distress; Fetal Monitoring; Fourier Transform; Frequencies; Future; Induced Labor; Infusion procedures; Intervention; Methods; Monitor; Mothers; Muscle; Outcome; Oxytocin; Patients; Pattern; Pharmaceutical Preparations; Phase; Prospective Studies; Provider; Reporting; Risk; Signal Transduction; Small Business Innovation Research Grant; Source; Summary Reports; System; Time; Uterine Contraction; Uterine Monitoring; Uterus; Woman; Work; adverse outcome; base; bioelectricity; clinical development; clinical research site; clinical risk; design; experience; fetal; health care delivery; individual response; individual variation; neonatal sepsis; signal processing; success; tool; vigilance

Approximately 30% of all women in the US (over 1,200,000 annually) are exposed to IV oxytocin at some point during labor to increase the frequency and strength of uterine contractions. Oxytocin is classified as a high-alert medication requiring clinical vigilance. Oxytocin is generally safe, but adverse outcomes arise when contractions become too frequent, a condition called tachysystole. Tachysystole is associated with fetal distress resulting in emergency Cesarean delivery (RR 2), neonatal sepsis (RR 2.0), NICU admissions (RR 1.6) and depressed fetal outcomes (RR 1.5). To date, clinical vigilance alone has not sufficiently reduced these oxytocin-related clinical risks. There are marked variations of individual responses to oxytocin, with some patients contracting robustly at low doses, while others require high doses to express mild contractions. Without a reliable, non-invasive method to monitor the effects of oxytocin on the uterus, it remains difficult to effectively administer. The use of tocodynamometry (toco), the standard method of assessing contractions during labor, unfortunately results in 20% of patients experiencing tachysystole. This high rate is a serious gap in obstetrical practice. Electromyography offers an alternate method of assessing uterine contractions since bioelectrical signals are produced as the muscle contracts. Interestingly, it long been appreciated that uterine bioelectrical signals are also produced between contractions. These signals are the source of “false positive contraction” reporting in commercial EMG-based systems. However, to date there have been no explanations of the source, importance, or meaning of these signals. In our preliminary uterine EMG studies, we found these “between contractions” signals are prominent during oxytocin use. Furthermore, as the uterine contraction pattern approaches tachysystole, our analysis suggests that oxytocin-associated EMG signals last longer (2-3 minutes) and appear more frequently. In subjects that meet the clinical criteria of tachysystole, the oxytocin-associated signals are seen in all channels and persist even longer (3 to 10 minutes). In this Phase I SBIR project, we will show the feasibility of isolating the oxytocin-associated signals from raw data in real time (Aim 1). In Aim 2 we will use these signals to categorize the uterine contractions as 1) normal; 2) early oxytocin effects; 3) precursor to tachysystole; 4) tachysystole. Identifying the precursor to tachysystole will allow clinicians to know when additional oxytocin infusion is inadvisable and avoid tachysystole. This will close the gap in the practice of oxytocin management for induction of labor.

大约 30% 的美国女性（每年超过 1,200,000 名）在分娩过程中的某个时刻接受静脉注射催产素，以增加子宫收缩的频率和强度。催产素被归类为需要临床警惕的高度警惕药物。催产素通常是安全的，但当宫缩变得过于频繁时，就会出现不良后果，这种情况称为收缩期过速。心动过速与胎儿窘迫相关，导致紧急剖宫产 (RR 2)、新生儿败血症 (RR 2.0)、NICU 入院 (RR 1.6) 和胎儿结局抑郁 (RR 1.5)。迄今为止，仅靠临床警惕还不足以降低这些与催产素相关的临床风险。个体对催产素的反应存在显着差异，一些患者在低剂量时会剧烈收缩，而另一些患者则需要高剂量才能表现出轻微的收缩。如果没有可靠的、非侵入性的方法来监测催产素对子宫的影响，仍然很难有效地施用。不幸的是，使用分娩测力法 (toco)（评估分娩期间宫缩的标准方法）会导致 20% 的患者出现收缩过速。如此高的比率是产科实践中的一个严重差距。肌电图提供了另一种评估子宫收缩的方法，因为生物电信号是在肌肉收缩时产生的。有趣的是，人们很早就认识到子宫生物电信号也会在宫缩之间产生。这些信号是基于肌电图的商业系统中“假阳性收缩”报告的来源。然而，迄今为止，还没有对这些信号的来源、重要性或含义做出解释。在我们的初步子宫肌电图研究中，我们发现这些“宫缩之间”信号在使用催产素期间很突出。此外，随着子宫收缩模式接近收缩速，我们的分析表明，催产素相关的肌电图信号持续时间更长（2-3 分钟）并且出现更频繁。在符合心动过速临床标准的受试者中，催产素相关信号在所有通道中均可见，并且持续时间更长（3 至 10 分钟）。在此第一阶段 SBIR 项目中，我们将展示从原始数据中实时分离催产素相关信号的可行性（目标 1）。在目标 2 中，我们将使用这些信号将子宫收缩分类为 1) 正常； 2）早期催产素作用； 3) 心搏过速的前兆； 4）心搏过速。识别心动过速的前兆将使临床医生知道何时不宜额外输注催产素并避免心动过速。这将缩小引产催产素管理实践中的差距。