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

一项多中心实用随机试验，评估门诊 Foley 导管对未产妇宫颈成熟的有效性和安全性：1 型混合有效性实施研究

• 批准号: 10705679
• 负责人: ALISON G CAHILL
• 金额: $ 67.61万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-21 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10705679
• 关键词: Abnormal placentation; Birth; COVID-19 pandemic; Caring; Catheters; Cervical Ripening; Cesarean section; Client satisfaction; Data; Diagnosis; Diagnostic; Dissemination and Implementation; Effectiveness; Endometritis; Exposure to; Future; Goals; Health system; Hemorrhage; Home; Hospitals; Hypoglycemia; Induced Labor; Infection; Inpatients; Internal Medicine; Intervention; Interview; Label; Labor Dystocia; Measures; Medical; Meta-Analysis; Methods; Morbidity - disease rate; Multicenter Trials; Neonatal; Nulliparity; Nurses; Outpatients; Patients; Perception; Pregnancy; Procedures; Process; Provider; Public Health; Publishing; Randomized; Relaxation; Resources; Respiratory distress; Risk; Risk Reduction; Safety; Sepsis; Shapes; Surveys; Testing; Time; Transfusion; Visit; Woman; Wound Infection; arm; care delivery; cost; effectiveness evaluation; effectiveness outcome; effectiveness study; effectiveness/implementation study; effectiveness/implementation trial; health care service utilization; hospital readmission; implementation determinants; implementation facilitators; improved; improvement on sleep; innovation; insight; maternal morbidity; maternal outcome; maternal risk; neonatal hypoxic-ischemic brain injury; neonatal morbidity; novel; parous; pragmatic randomized trial; randomized trial; safety outcomes; satisfaction; standard of care; uptake; venous thromboembolism

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.

项目摘要 美国每年有超过一百万妇女接受引产，超过三分之一的引产结束 剖腹产（CD）。虽然影响 CD 率的因素有很多，但改变引产的开始时间（例如， 宫颈成熟）从住院病人到门诊病人的环境是一种干预措施，可以塑造早期病程 劳动并显着降低 CD 的风险。降低 CD 率的可能机制包括改善睡眠 在家放松，但也减少了在医院的时间，进而减少了医疗干预 以及减少异常产程诊断中的变异性。根据已发表的 有证据表明，住院时间的减少与干预措施的减少以及早期有效性有关 根据门诊 Foley 的小型研究数据，我们假设改变诱导过程的第一部分 从医院转移到门诊将是降低 CD 率的一种有前途但未得到充分利用的方法。 此外，在门诊环境中提供家庭护理已被证明可以提高医疗保健利用率 通过减少内科住院时间来降低成本。 COVID-19 大流行进一步 现在强调现在是思考新颖和创新方法让患者远离医院的关键时刻。这 将是第一个针对门诊宫颈成熟的大型多中心试验，旨在确定这两种效果 以及门诊弗利的安全。 我们提出了一项大型（2300 名女性）、多中心、务实、随机试验来检验以下中心假设： 使用 Foley 导管进行门诊宫颈成熟术将 1) 降低原发性 CD 率，2) 减少产妇 和新生儿发病率。鉴于有效性研究和广泛实施之间存在较长时间滞后， 我们还将探讨实施的障碍和促进因素，以实现快速吸收和传播 我们的发现。通过 1 类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 促宫颈成熟术在降低宫颈癌发生率方面的有效性 接受引产的未产妇，（2）确定门诊 Foley 在减少 孕产妇和新生儿发病率并提高患者满意度，以及 (3) 描述患者、提供者、 与门诊与住院宫颈成熟相关的组织实施决定因素 福利导管。其他分析还将比较孕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否定的，我们也将有能力评估 次要有效性和安全性结果，主要实施目标将深入了解 通过比较实施情况来改进数千名患者的诱导过程的方法 两个部门之间的决定因素和资源利用。