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 每年有超过一百万的妇女在美国进行劳动入职，而三分之一以上的入职结束了 在剖宫产（CD）中。尽管许多因素导致CD率，但转移了劳动诱导的开始（例如 宫颈成熟）从住院到门诊环境，是一种干预措施，可以塑造早期过程 劳动并大大降低CD的风险。较低CD率的可能机制包括改善睡眠 在家里放松，但医院的时间也有所下降，进而减少医疗干预措施 以及诊断异常劳动进度诊断的变异性的降低。根据已出版 医院时间缩短的证据与干预措施减少以及早期有效性有关 来自门诊福利小型研究的数据，我们假设改变了归纳过程的第一部分 从医院到门诊环境将是一种有希望的降低CD率的有前途且不足的方法。 此外，在家中，在门诊环境中的护理交付已被证明可以改善医疗保健利用率 并通过减少内科医院的时间来降低费用。 19009大流行有进一步 现在强调，是考虑将患者远离医院的新颖和创新方法的关键时刻。这 将是对门诊宫颈成熟的首次大型多中心试验，以确定这两种有效性 和门诊的安全性。 我们提出了一个大型（2300名女性），多中心，务实的随机试验，以检验中心假设，即 通过Foley导管的门诊宫颈化成熟将1）降低主要CD速率，2）降低母亲 和新生儿发病率。考虑到有效性研究与广泛实施之间的长期差异， 我们还将探索实施障碍和促进者，以便快速吸收和传播 我们的发现。通过1型混合有效性 - 实现研究，我们将追求以下特定的特定 目的：（1）确定门诊Foley对宫颈成熟的有效性降低CD的速率 无效的妇女接受劳动归纳，（2）确定门诊佛利在降低的有效性 孕产妇和新生儿发病率并提高患者满意度，（3）表征患者，提供者， 以及与门诊和住院子宫颈成熟有关的组织实施决定因素 Foley导管。其他分析还将比较孕产妇和新生儿资源的利用率。 对这种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，我们也将有能力评估 次要有效性和安全性结果，主要实施目标将使您深入了解 通过比较实施，改善数千名患者的诱导过程的方法 两臂之间的决定因素和资源利用。