PREDICTING FETAL ACIDEMIA WITH INTRAPARTUM ELECTRONIC FETAL HEART RATE MONITORING

通过产时电子胎心率监测预测胎儿酸血症

• 批准号: 7889747
• 负责人: ALISON G CAHILL
• 金额: $ 55.32万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-06 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7889747
• 关键词: Abdomen; Academia; Acute; Address; Advisory Committees; American College of Obstetricians and Gynecologists; Area; Birth; Cerebral Palsy; Cerebrum; Characteristics; Child; Child health care; Classification; Clinical; Cohort Studies; Consensus; Deceleration; Devices; Discipline of obstetrics; Dose; Electronics; Elements; Fetal Heart Rate; Fetal Monitoring; Fetus; Gases; Goals; Gynecologist; Health Priorities; Human Development; Infant; Injury; Institutes; Joints; Knowledge; Magnetic Resonance Imaging; Measures; Metabolic; Monitor; Neonatal; Nested Case-Control Study; Neurologic; Observational Study; Outcome; Patients; Pattern; Predictive Value; Principal Investigator; Research; Research Design; Research Personnel; Services; Severities; Site; Societies; Time; Umbilical cord structure; United States; Woman; Women' s Health; base; clinical practice; fetal; fetal medicine; fetus at risk; high risk; improved; indexing; instrument; intrapartum; novel; patient population; public health relevance; respiratory; response; stillbirth; symposium; tool

DESCRIPTION (provided by investigator): Intrapartum electronic fetal heart rate monitoring (EFM) has become the most frequently used instrument in obstetrics in the United States, despite its classification as a "D" by the U.S. Preventative Services Task Force, signifying the lack of evidence for benefit and the potential for harm. EFM rapidly gained ubiquitous use prior to evidence of benefit from properly conducted research. Today, despite the available evidence that EFM does not reduce the rate of cerebral palsy or stillbirth, its use is widespread; intrapartum EFM was used in 3,585,390 births in the U.S. in 2005. At a joint consensus conference in May of 2008 sponsored by the American College of Obstetricians and Gynecologists (ACOG), the Society of Maternal Fetal Medicine (SMFM), and the Eunice Kennedy Shriver Nation Institute of Child Health and Human Development (NICHD) the leading experts in obstetrics and fetal monitoring re-convened to prioritize areas for research and to reevaluate the definitions that were set forth by a similar group 11 years before. The group acknowledged that no evidence had emerged on EFM since the 1997 consensus conference, despite the ubiquitous use of EFM, and again called for well-designed studies to fill the significant knowledge gaps which continue to exist1. One of the areas of highest importance sited was observational studies focused on indeterminate EFM patterns, which is addressed in this proposed study. Fetal heart rate decelerations are the most common component of indeterminate EFM patterns seen in daily clinical practice. To better understand the relationship between fetal heart rate decelerations and fetal academia, this proposed cohort study of over 7,000 women examines the predictive value of characteristics of fetal decelerations, using novel and established measures, for fetal academia and early evidence of neonatal neurologic injury. The specific aims of this proposed project are to estimate the association between indeterminate EFM recordings, particularly fetal heart rate decelerations, and fetal academia (measured by arterial umbilical cord gas analysis at delivery), academia subtypes, and measures of neonatal cerebral injury. The study uses standard and novel ways to assess the EFM recordings of women during the 120 minutes prior to delivery and assess their association with or predictive ability for fetal academia, alone or in combination. Ultimately the goal is to develop and validate a clinical predictive index for fetal academia and neonatal cerebral injury based on features of EFM encountered everyday in clinical practice, for which the meaning is currently unknown. This study will address an issue of priority for NICHD, and more importantly, an issue of priority for the health of women and their children. PUBLIC HEALTH RELEVANCE: Intrapartum electronic fetal monitoring (EFM) is the most commonly used tool in obstetrics. But it has never been shown to improve the health of women or their babies. This study will begin to fill the knowledge gap that exists between what obstetricians see every day on EFM and how babies are actually doing.

描述（由研究者提供）：产时电子胎心率监测 (EFM) 已成为美国产科最常用的仪器，尽管它被美国预防服务工作组分类为“D”级，表明缺乏证据证明其益处和潜在危害。在有证据表明正确进行的研究有益之前，EFM 迅速获得了普遍的使用。如今，尽管有证据表明 EFM 并不能降低脑瘫或死产的发生率，但它的使用还是很广泛的。 2005 年，美国有 3,585,390 名新生儿使用了产时 EFM。2008 年 5 月，在美国妇产科医师学会 (ACOG)、母胎医学协会 (SMFM) 和尤尼斯·肯尼迪·施赖弗国家儿童健康与人类发展研究所 (NICHD) 主办的联合共识会议上，产科和胎儿监测方面的领先专家 重新召开会议，确定研究领域的优先顺序，并重新评估 11 年前类似小组提出的定义。该小组承认，自 1997 年共识会议以来，尽管 EFM 的使用无处不在，但尚未出现任何关于 EFM 的证据，并再次呼吁进行精心设计的研究，以填补仍然存在的重大知识空白。最重要的领域之一是针对不确定 EFM 模式的观察性研究，这在本拟议研究中得到解决。 胎心率减速是日常临床实践中不确定的 EFM 模式中最常见的组成部分。为了更好地了解胎心率减慢与胎儿学术界之间的关系，这项拟议的对 7,000 多名妇女进行的队列研究使用新颖和既定的措施检查了胎儿减速特征对胎儿学术界和新生儿神经损伤早期证据的预测价值。该拟议项目的具体目标是估计不确定的 EFM 记录（特别是胎儿心率减速）与胎儿学术界（通过分娩时动脉脐带气体分析进行测量）、学术界亚型和新生儿脑损伤测量之间的关联。该研究使用标准和新颖的方法来评估女性在分娩前 120 分钟的 EFM 记录，并单独或组合评估其与胎儿学术界的关联或预测能力。最终目标是根据临床实践中日常遇到的 EFM 特征，开发和验证胎儿学术界和新生儿脑损伤的临床预测指数，但其意义目前尚不清楚。这项研究将解决NICHD的优先问题，更重要的是，解决妇女及其儿童健康的优先问题。 公共健康相关性：产时胎儿电子监护 (EFM) 是产科最常用的工具。但从未证明它可以改善妇女或其婴儿的健康。这项研究将开始填补产科医生每天在 EFM 上看到的情况与婴儿实际情况之间存在的知识差距。