A multicenter pragmatic randomized trial evaluating effectiveness and safety of outpatient Foley catheter for cervical ripening in nulliparous women: a Type 1 hybrid effectiveness-implementation study

项目摘要 在美国，每年有100多万妇女接受引产，超过三分之一的引产结束 剖宫产(CD)。虽然许多因素对CD率有影响，但改变引产开始时间(例如 宫颈成熟)从住院到门诊是一种干预措施，可以塑造 分娩和CD的风险显著降低。降低CD率的可能机制包括改善睡眠 和在家放松，但也减少了在医院的时间，进而减少了医疗干预 以及在诊断异常分娩过程中暴露于变异性的减少。基于已发布的 有证据表明，住院时间的减少与干预措施的减少以及早期疗效有关 来自门诊病人福利的小规模研究的数据，我们假设转移诱导过程的第一部分 从医院到门诊环境将是降低CD比率的一个有希望且未得到充分利用的方法。 此外，在家庭门诊环境中提供护理服务已被证明提高了医疗保健的利用率 并通过减少内科住院时间来降低成本。新冠肺炎大流行进一步 现在被强调为一个关键时刻，需要考虑新的和创新的方法，使患者远离医院。这 将是第一个关于门诊宫颈成熟的大型多中心试验，以确定两者的有效性 以及门诊病人福利的安全。 我们提出了一项大型(2300名女性)、多中心、务实的随机试验来检验这一中心假设 使用Foley导尿管的门诊宫颈成熟术将1)降低原发CD发生率，2)减少母亲 和新生儿发病率。鉴于有效性研究和广泛执行之间存在很长的时间间隔， 此外，我们还将探讨实施的障碍和促进者，以实现快速吸收和传播 我们的发现。通过类型1混合有效性-实施研究，我们将追求以下具体目标 目的：(1)确定门诊Foley促宫颈成熟对降低以下人群CD发生率的效果 未分娩妇女引产，(2)确定门诊福利减少的效果 孕产妇和新生儿发病率和提高患者满意度，以及(3)确定患者、提供者、 以及与门诊患者和住院患者宫颈成熟相关的组织实施决定因素 弗利导尿管。其他分析还将比较产妇和新生儿的资源利用情况。 如此规模和严格的试验对于改变数百万分娩妇女的护理标准至关重要。 至关重要的是，即使我们的主要有效性目标是负面的，我们也将有权进行评估 二次有效性和安全结果，主要实施目标将产生洞察 通过实施对比，改进对数千名患者的诱导过程 决定因素和两个部门之间的资源利用。

PROJECT ABSTRACT More than one million women undergo labor induction in the U.S. annually and over one-third of inductions end in cesarean delivery (CD). While many factors contribute to the CD rate, shifting the start of labor induction (e.g. cervical ripening) from an inpatient to outpatient setting is an intervention that can shape the early course of labor and significantly reduce the risk of CD. Possible mechanisms for the lower CD rate include improved sleep and relaxation at home, but also decreased time in the hospital and in turn, a decrease in medical interventions as well as a decreased exposure to variability in the diagnosis of abnormal labor progress. Based on published evidence that reduced time in the hospital is associated with reduced interventions, as well as early effectiveness data from small studies of outpatient Foley, we hypothesize that shifting the first part of the induction process from hospital to outpatient setting will be a promising and underutilized way to decrease CD rates. Furthermore, care delivery at home, in the outpatient setting, has been shown to improve healthcare utilization and cost by decreasing time in the hospital within internal medicine. The COVID-19 pandemic has further highlighted now as a critical time to think of novel and innovative ways to keep patients out of the hospital. This will be the first large, multicenter trial on outpatient cervical ripening powered to determine both effectiveness and safety of outpatient Foley. We propose a large (2300 women), multicenter, pragmatic, randomized trial to test the central hypothesis that outpatient cervical ripening with a Foley catheter will 1) decrease the primary CD rate and 2) reduce maternal and neonatal morbidity. Given the long time-lag between effectiveness studies and widespread implementation, we will additionally explore barriers and facilitators to implementation to enable rapid uptake and dissemination of our findings. Through a Type 1 hybrid effectiveness-implementation study, we will pursue the following specific aims: (1) Determine the effectiveness of outpatient Foley for cervical ripening in reducing the rate of CD among nulliparous women undergoing labor induction, (2) Determine the effectiveness of outpatient Foley in reducing maternal and neonatal morbidity and improving patient satisfaction, and (3) To characterize patient, provider, and organizational implementation determinants relevant to outpatient versus inpatient cervical ripening with a Foley catheter. Additional analyses will also compare maternal and neonatal resource utilization. A trial of this size and rigor is critical to changing the standard of care for millions of delivering women. Of critical importance, even if our primary effectiveness aim is negative, we will be powered to evaluate secondary effectiveness and safety outcomes, and the primary implementation aim will yield insight into ways to improve the induction process for thousands of patients through comparison of implementation determinants and resource utilization between the two arms.