Inpatient versus outpatient transcervical Foley catheter use for cervical ripening: a randomized controlled trial

Abstract

To evaluate the difference in time from hospital admission to delivery when undergoing inpatient versus outpatient cervical ripening with a transcervical Foley catheter. This was a randomized controlled trial of patients with singleton pregnancies, Bishop Score ≤ 6 and at least 37 weeks’ gestation, undergoing labor induction at Sinai Hospital of Baltimore and Thomas Jefferson University Hospital. Patients were randomized to outpatient or inpatient cervical ripening with a Foley catheter. Inpatients received concurrent oxytocin. Outpatients returned 12 hours after Foley placement, and on arrival oxytocin was initiated if the balloon was still in place. Foleys were removed if in place after 12-18 hours, and labor induction initiated with oxytocin as needed. The primary outcome was the difference in time from admission to delivery. A maternal satisfaction survey was also administered. Unpaired t-tests, chi-square tests, and Fisher’s exact test were performed to estimate differences in outcomes between the inpatient and outpatient arms of the study. Enrollment commenced January 2016 and continued until November 2020, after randomizing 30 patients (n=15 per group). The study was terminated prematurely due to low enrollment and temporary suspension during COVID-19. There was no significant difference in time from admission to delivery between outpatient and inpatient groups (14.5 ± 6.1 versus 18.9 ± 8.2 hours, P=.11). The total induction time was shorter for the inpatient group (24.9 ± 6.8 versus 17.3 ± 9.4 hours, P=.02). There were no differences in other maternal or neonatal outcomes (P>.05). Maternal satisfaction was similar between groups on a 1-10 scale (8.6 ± 1.7 versus 8.9 ± 1.0, P=.53), and all patients felt safe. No difference in the primary outcome of time from admission to delivery was noted between inpatient and outpatient cervical ripening with a Foley catheter; however, this may be a result of inadequate power related to early termination. Consistent with past studies, outpatient balloon cervical ripening appears to be safe, and overall satisfaction was high.View Large Image Figure ViewerDownload Hi-res image Download (PPT)