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: 7990663
• 负责人: JEREMY L NEAL
• 金额: $ 7.63万
• 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 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7990663
• 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; Leukocytes; Logistic Regressions; Measurement; Measures; Mediating; Modeling; Outcome; Oxytocin; Physiology; Pilot Projects; Process; Protein C; Protocols documentation; Provider; ROC Curve; Regression Analysis; Reporting; Research; Risk; Running; Serum; Time; Tissues; Trial of Labor; Tumor Necrosis Factor-alpha; Tumor Necrosis Factors; 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; peripheral blood; 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）：分娩护理提供者通常旨在在“活跃”分娩开始时（即预计宫颈扩张率增加时）将待产妇女接纳到分娩单位。然而，积极分娩只能根据宫扩张随时间的变化来回顾性确定。报告表明，大约一半的定期收缩、低风险、未生育的妇女在积极分娩之前就入院分娩。这些妇女在分娩过程中更容易接受干预，其中剖腹产的风险是积极分娩的妇女的两倍多。这些数据表明，需要额外的标准来更准确地确定入院前的临产状态。越来越多的证据表明，分娩的开始和进展是由炎症事件介导的，并且随着分娩的进展，在生殖组织和母体血液中越来越多地可检测到炎症生物标志物。本研究的目的是确定炎症生物标志物是否有助于预测活跃分娩开始。据推测，随着时间的推移，特定炎症生物标志物的增加可以预测因自然分娩而入院的低风险、未产妇 (n = 200) 的主动扩张状态（平均 > 0.5 厘米/小时，在入院后的前 4 小时内）。将使用描述性比较设计来评估特定炎症生物标志物变化率之间的关联[即白细胞（WBC）计数、血清促炎细胞因子（IL-12、IL-6、IL-8、TNF-1）、C反应蛋白（CRP）；和体温]随着时间的推移以及入院后前 4 小时内宫颈扩张的量。将在入院时以及 2 小时和 4 小时后再次测量炎症生物标志物。将评估的特定炎症生物标志物随时间的变化包括入院->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个体炎症生物标志物的变化幅度将用于构建预测活跃分娩的 ROC 曲线。根据生物标志物变化的幅度进行逻辑回归分析，并将分娩分类作为因变量，即主动或不主动扩张。入院时的宫颈扩张和几种常见的分娩干预措施将作为模型协变量包括在内。还将考虑同时运行多种炎症生物标志物的模型。如果炎症生物标志物随时间的急剧变化与活跃的临产有关，那么在决定“何时”让待产妇女进入产房时可以使用这些生物标志物。最大限度地增加积极分娩的女性人数是改善分娩结果的重要一步。这项研究的结果将用于指导制定基于生理学的分娩评估方案，旨在最大限度地增加主动分娩时或之后入院的妇女人数。后续研究还将确定临床干预对分娩相关炎症介质的影响。 公共卫生相关性：炎症事件与分娩的开始和进展有关。因此，炎症生物标志物的测量可以预测活跃的临产发作，目前只能回顾性地确定——通常是在做出入院决定数小时后。大约有一半的规律性宫缩、低风险、未产妇在积极分娩前入院分娩，这一高产群体中的妇女更容易在分娩过程中接受干预，其中剖宫产的风险是积极分娩妇女的两倍多。如果炎症生物标志物随时间的急剧变化可以有效预测活跃分娩的发生，那么它们的测量结果可用于最大限度地增加活跃分娩的女性数量。随之而来的是更积极的短期和长期劳动力成果。