Spontaneous vs. Directed Pushing: Analysis of Audiotapes of 2nd stage Labor and A

描述(由申请人提供)：分娩会增加女性一生经历与大小便失禁相关的盆底不良变化的风险，对她的生活质量产生负面影响。第二产程的管理是一个与盆底健康相关的可修改因素。女性在第二阶段如何推动，无论是自发的还是直接的，可能会影响这种风险。随机临床试验PERL：尿失禁预防：降低分娩风险(R01-NR4007)的研究结果表明，自发推入法并不能显著减少产后尿漏。然而，使用第二产程的录音带对参与者(N=58)的子集进行审查表明，由于提供者和参与者的原因，对小组分配(自发或指导)的忠诚度并不一致。在这个子集中，对评估实际推送方法的录音带的分析倾向于显著地表明自发推送对减少产后渗漏的益处(p=0.048)，但动力不足。为了减少育龄妇女大小便失禁的风险，我们需要扩大有关第二阶段和预防盆底不良改变的科学证据。因此，将使用定性和定量的方法对162盘录音带进行二次分析，这些录音带代表了17,929分钟的第二阶段分娩，以确定与随机分配和相关提供者沟通相比的实际推送。利用录音劳动互动片段，以30名床边产科护理提供者为目标的焦点小组将完成在实施第二阶段战略时调查临床考虑因素。本项目的目的是：目的1：探讨第二产程实际使用的助推方法与产后大小便失禁风险的关系。H1：我们假设在第二产程和第二产程期间，通过随机分配的原始分配和实际的推动努力之间将会发生显著的交叉效应。使用实际推进式分组与随机分组相比，自发组产后12个月尿漏严重程度明显低于指导组。目的2：调查产妇保健提供者对影响他们如何管理第二产程的临床指标的基本原理和描述，并记录提供者的口头指导如何在第二产程中响应母亲的推动努力而改变。H3：我们假设产妇保健提供者鼓励的推力方法(直接的或自发的)是动态的；受时间、顶点的可见性和分娩妇女的反应的影响。这项调查将为前瞻性试验测试提供者使用基于证据的第二阶段管理策略和预防盆底不良变化奠定基础。在每年分娩的近300万妇女中，即使减少5%的大小便失禁，每年也可以减轻14万多名妇女的这种负担。 公共卫生相关性：分娩被认为增加了女性一生经历盆底变化的风险，包括大小便失禁，这些变化对女性的生活质量产生了负面影响。导致阴道分娩的第二产程是与盆底变化相关的最重要的可改变因素，在这一阶段中，女性如何自发或按照医疗保健提供者的指示进行推力被假设为影响这种风险。我们在这个项目中的目标是确定女性如何推动和她的大小便失禁风险之间的联系，以便我们能够帮助医疗保健提供者预防与分娩相关的失禁，这是在预防关键女性健康状况方面的明智的公共卫生投资。

DESCRIPTION (provided by applicant): Childbirth is implicated in increasing a woman's lifetime risk of experiencing adverse pelvic floor changes associated with incontinence, negatively impacting her quality of life. Management of 2nd stage labor is a modifiable factor related to pelvic floor health. How a woman pushes during 2nd stage, either spontaneously or directed, may affect this risk. Findings from the randomized clinical trial PERL: Urinary Incontinence Prevention: Reducing Birthing Risk (R01-NR4007) suggests spontaneous pushing method does not significantly decrease urinary leakage post partum. However, review of a subset of participants (N=58) using audiotapes from their 2nd stage labor indicate fidelity to group assignment (spontaneous or directed) was not consistently maintained due to provider and participant reasons. In this subset, analysis of audiotapes assessing actual pushing method trends towards significance indicating benefit of spontaneous pushing to reduce post partum leakage (p= 0.048) but is under powered. The need to reduce incontinence risk in childbearing women demands we expand the scientific evidence available regarding 2nd stage and prevention of adverse pelvic floor changes. Therefore a secondary analysis of 162 audiotapes representing 17,929 minutes of 2nd stage labor will be done using qualitative and quantitative methods to determine actual pushing compared to randomized assignment and associated provider communication. Using segments of audio taped labor interaction, focus groups targeting 30 bedside maternity care providers will be completed investigating clinical considerations in implementing 2nd stage strategies. The AIMS of this project are to: Aim 1: Investigate the relationship between actual pushing method used during 2nd stage labor and risk for incontinence post partum. H1: We hypothesize there will be a significant cross over effect that occurs between original assignment through randomization and actual pushing effort during 2nd stage labor and H2. Using actual pushing type for group assignment compared to random group assignment, severity of urine leakage at 12 months post partum will be significantly less in the spontaneous compared to directed group. AIM 2: Investigate maternity care providers' rationale and description of clinical indicators that influence how they manage 2nd stage labor and document how provider verbal instruction may change in response to maternal pushing efforts over the course of 2nd stage labor. H3: We hypothesize that pushing method (directed or spontaneous) encouraged by maternity care providers is dynamic; influenced by time, visibility of the vertex and response of the laboring woman. This investigation will be the foundation for a prospective trial testing provider use of evidence based 2nd stage management strategies and prevention of adverse pelvic floor changes. Reducing incontinence in even 5% of the almost 3 million women who give birth annually removes this burden in over 140,000 women annually. PUBLIC HEALTH RELEVANCE: Childbirth have been implicated as increasing a woman's lifetime risk of experiencing pelvic floor changes, including incontinence, that negatively impact a woman's quality of life. The second stage of labor resulting in vaginal birth is the most important modifiable factor related to pelvic floor changes and how a woman pushes during this phase, either spontaneously or as directed by a health care provider is hypothesized to affect this risk. Our goal in this project is to determine the linkage between how a woman pushes and her risk of incontinence so that we can aid health care providers in the prevention of incontinence associated with childbirth representing a wise public health investment in prevention of a critical women's health condition.