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

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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.