Prospective randomized controlled trial comparing inpatient and outpatient Foley catheter cervical ripening

Abstract Background To evaluate the safety of Foley catheter cervical ripening and patients’ satisfaction in outpatient versus inpatient setting. Methods Sixty low risk women were randomized to outpatient (n = 25) and inpatient (n = 35) cervical ripening using Foley catheter. In both groups Foley catheter with 60 ml balloon was digitally inserted through the cervix with gentle traction applied. The outpatient group was discharged home after provision of verbal and written 24-hours contact information and instructions. The inpatient group was admitted to the ward. They were reassessed the next morning unless labor had begun or the catheter had dropped off. Results The demographic data between the two groups did not differ. The outpatient group has significant improvement in the Bishop score at second assessment (9.04 versus 7.89, p = 0.04), reduced duration of inpatient stay (41 versus 59, p < 0.001), able to sleep 5–6 hours (9 versus 1, p = 0.001), able to rest (23 versus 16, p = 0.001) and relax (23 versus 10, p < 0.001). Significantly, more women in the inpatient group had wished to be in the outpatient group (3 versus 21, p < 0.001). There was no difference in initial Bishop score, duration of oxytocin infusion and delivery within 24 hours. Both groups were similar in caesarean section rate, total blood loss, maternal and neonatal infection, primary postpartum hemorrhage, neonatal birthweight and cord pH. There was no incidence of uterine hyperstimulation, meconium aspiration syndrome and neonatal intensive care unit admission. Conclusion Outpatient Foley catheter cervical ripening had comparable efficacy and safety with inpatient for low-risk pregnancies and associated with better patient satisfaction. Trial registration: NCT04342741. It was retrospectively registered with ClinicalTrial.gov