PREDICTING FETAL ACIDEMIA WITH INTRAPARTUM ELECTRONIC FETAL HEART RATE MONITORING

描述(由研究人员提供)：产中电子胎心率监测(EFM)已成为美国产科最常用的工具，尽管它被美国预防服务工作组归类为D级，这意味着缺乏有益和潜在危害的证据。在有证据表明从适当的研究中受益之前，EFM迅速得到了普遍使用。今天，尽管有证据表明EFM不能降低脑瘫或死产的发生率，但它的使用很广泛；2005年，美国有3585,390名新生儿在产中使用EFM。在2008年5月由美国妇产科医师学会(ACOG)、母胎医学会(SMFM)和尤尼斯·肯尼迪·施莱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，产科和胎儿监测领域的主要专家重新召开会议，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年协商一致会议以来，没有出现关于环境监测的证据，尽管普遍使用了环境监测，并再次呼吁进行精心设计的研究，以填补继续存在的重大知识空白1。最重要的领域之一是关注不确定EFM模式的观察性研究，这一点在这项拟议的研究中得到解决。胎心率减速是日常临床实践中最常见的不确定EFM模式的组成部分。为了更好地了解胎儿心率减速和胎儿学术之间的关系，这项拟议的队列研究对7000多名女性进行了研究，使用新的和既定的方法，检验了胎儿减速特征对胎儿学术和新生儿神经损伤的早期证据的预测价值。这个拟议项目的具体目标是评估不确定的EFM记录，特别是胎儿心率减速，与胎儿学术(通过分娩时的脐带动脉气体分析测量)、学术亚型和新生儿脑损伤测量之间的关联。这项研究使用标准和新颖的方法来评估妇女在分娩前120分钟内的EFM记录，并单独或联合评估她们与胎儿学术界的关联或预测能力。最终的目标是基于临床实践中每天遇到的EFM的特征，开发和验证一个对胎儿学术界和新生儿脑损伤的临床预测指标，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，妇女及其子女的健康优先问题。

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.