A Randomized Study Comparing Outpatient and Inpatient Foley Catheter Use for Cervical Ripening in First-Time Mothers at Term

What this Trial Is About

Researchers are evaluating a method of cervical ripening using a Foley catheter for women who are having their first baby and are scheduled for labor induction at term 37 weeks or more. The study compares outpatient cervical ripening with a Foley catheter to the usual inpatient cervical ripening methods. The aim is to see if outpatient use of the Foley catheter reduces the rate of Cesarean delivery and lowers risks for mothers and newborns compared to inpatient care. Participants will be randomly assigned to one of two groups one group will begin cervical ripening with a Foley balloon catheter at home outpatient, while the other group will start cervical ripening in the hospital using either a Foley balloon or another cervical ripening method. The trial focuses on comparing these approaches to find the best care process for labor induction. During the study, researchers will monitor Cesarean delivery rates at delivery as the primary outcome. They will also assess maternal and neonatal health up to 6 weeks after delivery, including maternal satisfaction, perceived control during birth, length of hospital stay, and neonatal intensive care admissions. Participants will be followed closely with various assessments and questionnaires to measure these outcomes and ensure safety throughout the postpartum period.

Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)