Inflammatory markers as predictors of active labor onset among nulliparous women

炎症标志物作为未产妇主动临产的预测因子

• 批准号: 8131013
• 负责人: JEREMY L NEAL
• 金额: $ 7.55万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-19 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8131013
• 关键词: Accounting; Acute; Admission activity; Affect; American College of Obstetricians and Gynecologists; Biological Markers; Birth; Blood; Body Temperature; C-reactive protein; Caring; Cervical; Cervical Dilatations; Classification; Contracts; Data; Data Collection; Decision Making; Development; Diagnosis; Dilatation - action; Dystocia; Event; Feedback; Goals; Guidelines; Hour; Individual; Inflammation Mediators; Inflammatory; Interleukin-12; Interleukin-6; Interleukin-8; Interleukins; Intervention; Labor Onset; Logistic Regressions; Measurement; Measures; Mediating; Modeling; Outcome; Oxytocin; Peripheral; Physiology; Pilot Projects; Process; Protocols documentation; Provider; ROC Curve; Regression Analysis; Reporting; Research; Risk; Running; Serum; Time; Tissues; Tumor Necrosis Factor-alpha; United States National Institutes of Health; Uterine Contraction; White Blood Cell Count procedure; Woman; base; clinical effect; comparative; cytokine; design; digital; evidence base; feeding; improved; inflammatory marker; lymphotoxin beta; programs; public health relevance; reproductive

DESCRIPTION (provided by applicant): Labor care providers typically aim to admit a laboring woman to the labor unit at the onset of "active" labor, i.e., when the rate of cervical dilation is anticipated to increase. However, active labor can only be determined retrospectively based on changes in dilatation over time. Reports indicate that approximately one-half of regularly contracting, low-risk, nulliparous women are admitted for labor prior to active labor. These women are more prone to intervention during labor including a more than two-fold risk of cesarean delivery compared to women admitted in active labor. These data suggest that additional criteria are needed to more accurately determine labor state prior to admission. Evidence increasingly suggests that labor onset and progression is mediated by inflammatory events and inflammatory biomarkers become increasingly detectable in reproductive tissues and maternal blood as labor advances. The purpose of this study is to determine if inflammatory biomarkers may assist in predicting active labor onset. It is hypothesized that increases in specific inflammatory biomarkers over time can predict an actively dilating state (> 0.5 cm/hr, on average, over the first 4 hrs after labor admission) among low-risk, nulliparous women admitted for spontaneous labor onset (n = 200). A descriptive, comparative design will be used to evaluate the association between rates of change in specific inflammatory biomarkers [i.e., white blood cell (WBC) count, serum pro-inflammatory cytokines (IL-12, IL-6, IL-8, TNF-1), C-reactive protein (CRP); and body temperature] over time and the amount of cervical dilation during the first 4 hrs post-admission. Inflammatory biomarkers will be measured at labor admission and again 2 hrs and 4 hrs later. Specific inflammatory biomarker changes over time that will be evaluated include admission -> admission+2hrs, admission -> admission+4hrs, and admission -> admission+2hrs -> admission+4hrs. The magnitude of change in individual inflammatory biomarkers between data collection time points will be used to construct ROC curves with respect to the prediction of active labor. Logistic regression analyses, based on the magnitude of biomarker change, will be performed with classification of labor as the dependent variable, i.e., actively or not actively dilating. Cervical dilatation at admission and several common labor interventions will be included as model covariates. Models running multiple inflammatory biomarkers simultaneously will also be considered. If acute changes in inflammatory biomarkers over time are associated with active labor onset, these biomarkers could be used when making decisions regarding "when" to admit laboring women to the labor room. Maximizing the number of women admitted in active labor is an important step toward improving labor outcomes. Findings from this study will be used to inform the development of a physiology-based labor assessment protocol aimed at maximizing the number of women admitted at or after the onset of active labor. Subsequent studies will also determine the effects that clinical interventions have on labor-associated inflammatory mediators. PUBLIC HEALTH RELEVANCE: Inflammatory events are implicated in initiating labor and propagating its progression. The measurement of inflammatory biomarkers may, therefore, be predictive of active labor onset which, at present, can only be determined retrospectively - often hours after a decision to admit for labor has already been made. Approximately one-half of regularly contracting, low-risk, nulliparous women are admitted for labor prior to active labor and women in this high-volume group are more prone to intervention during labor including a more than two-fold risk of cesarean delivery compared to women admitted in active labor. If acute changes in inflammatory biomarkers over time validly predict active labor onset, their measurement can be used to maximize the number of women admitted in active labor. More positive short- and long-term labor outcomes should follow.

描述（由申请人提供）：劳动护理提供者通常旨在在“主动”劳动力开始时承认一名劳动妇女到劳动部，即预计宫颈扩张率会增加。但是，只能基于随着时间的推移的扩张变化来追溯积极的劳动。报告表明，在积极劳动之前，约有一半定期签约，低风险的无效妇女被聘请劳动。与从事积极劳动的妇女相比，这些妇女在分娩过程中更容易进行干预，包括剖宫产的两倍以上。这些数据表明，需要其他标准以在入院之前更准确地确定劳动力状态。越来越多的证据表明，随着劳动组织的发展和炎症生物标志物，劳动和进展是由炎症性事件介导的，随着劳动力的发展，越来越多地在生殖组织和孕妇血液中检测到。这项研究的目的是确定炎症生物标志物是否可以帮助预测主动劳动发作。假设随着时间的推移，特定炎症生物标志物的增加可以预测在低危，无效的无效女性中，在劳动入院后的前4小时中，平均而言，> 0.5 cm/hr）承认自发劳动发作（n = 200）。描述性的比较设计将用于评估特定炎症生物标志物变化速率[即白细胞计数（WBC）计数，血清促炎细胞因子（IL-12，IL-6，IL-6，IL-8，TNF-1），C-功能蛋白（CRP）;随着时间的流逝和体温]和入选后前4小时的宫颈扩张量。炎症生物标志物将在劳动入院时进行测量，并在2小时和4小时后进行测量。随着时间的推移，特定的炎症生物标志物会随着时间的流逝而变化，包括入院 - >入院+2小时，入院 - >入院+4小时和入院 - >入院+2小时 - >入院+4小时。数据收集时间点之间单个炎症生物标志物的变化大小将用于构建ROC曲线相对于活跃劳动的预测。逻辑回归分析基于生物标志物变化的幅度，将通过将劳动分类作为因变量进行分类，即主动或不积极扩张。入院时宫颈扩张和几种常见的劳动干预措施将包括作为模型协变量。还将考虑同时运行多种炎症生物标志物的模型。如果随着时间的流逝，炎症生物标志物的急性变化与积极的劳动发作有关，则可以在“何时”承认劳动妇女到实验室时使用这些生物标志物。最大化在积极劳动中被录取的妇女人数是改善劳动成果的重要一步。这项研究的结果将用于为基于生理的劳动评估方案的发展提供信息，旨在最大程度地提高积极劳动发作或之后入学的妇女人数。随后的研究还将确定临床干预对劳动相关炎症介质的影响。 公共卫生相关性：炎症事件与劳动力和传播其进展有关。因此，炎症生物标志物的测量可能可以预测活跃的劳动发作，目前只能回顾性地确定 - 通常在决定接受劳动的决定后数小时就已经做出了。与积极劳动的妇女相比，大约一半的定期签约，低风险的妇女在积极劳动之前被纳入劳动和劳动劳动和妇女在劳动期间更容易进行干预。如果随着时间的流逝，炎症生物标志物的急性变化有效地预测了积极的劳动发作，则可以使用其测量来最大化积极劳动的女性数量。应遵循更多积极的短期和长期劳动成果。