Foley Catheter Induction

The foley catheter (single lumen balloon) is one of the most cost effective, readily available methods for cervical ripening to begin an induction of labor. It is most commonly used in conjunction with oxytocin, a medication given to induce contractions. However, there is no clear timeline for when to remove the foley catheter or how long foley catheters can be safely kept in place. The study team's goal is to conduct a randomized controlled trial (RCT) in nulliparous and multiparous patients to determine the optimal length of time to retain foley catheters (single balloon) for induction of labor to achieve vaginal delivery while shortening the overall length of labor. Based on our power analysis, the study team plans to enroll a total of 356 patients (218 nulliparous patients and 138 multiparous patients) over the course of 18 months. Then the study team will randomize patients to one of the following two groups: foley catheter removal after 6 hours or foley catheter removal after 12 hours. All patients will receive simultaneous pitocin and a foley catheter, and the remainder of the induction course (i.e. rupture of membranes, etc.) will be left to the discretion of the obstetric provider. The primary outcome will be time of foley catheter insertion to delivery. Secondary outcomes will be rates of cesarean delivery and obstetric/neonatal outcomes.

Inclusion Criteria:

- Age 18 through 50 years old

- Bishop score of 6 or less

- Singleton pregnancies at 37 weeks or more

- Absence of labor or rupture of membranes.

Exclusion Criteria:

- COVID positive patients

- Previous history of cesarean delivery

- Ruptured membranes (the institutional policy states women cannot have foley catheters placed if membranes are ruptured)

- Documented labor on admission (will include only patients being induced)

- Fetal distress on admission (e.g. indication for induction of labor being category 2 tracing as these patients may have increased risk of cesarean delivery)

- Certain fetal anomalies (e.g. brain anomalies, abdominal wall or neural tube defects, fetal cardiac arrhythmias)

- Contraindication to vaginal delivery