Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX): a Randomized Control Trial

The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity.

This is a multi-center, open-label, randomized study. Women with a singleton, vertex gestation between 24-42 weeks gestations presenting for labor induction will be offered participation in this study. Patients who receive prenatal care at Christiana Care may be approached if an induction of labor is scheduled and consented at their prenatal visit. All indications for induction will be included except those specifically mentioned as exclusion criteria. Any contraindication for vaginal delivery would exclude the subject. After informed consent is obtained, the Foley catheter will be placed and the subject will be randomized to receive oxytocin (study group) or not (control group). After Foley catheter removal or expulsion, the remainder of the induction course was left to the discretion of the primary provider. Prior to randomization, the subject will be placed into the nulliparous or multiparous group.

Inclusion Criteria:

• Age greater than 18 years
• Pregnant, singleton gestation, vertex presentation
• Admitted for induction of labor between gestational ages 24 - 42 weeks
• Bishop score <6

Exclusion Criteria:

• Multiple gestation
• Non-vertex presentation
• Latex allergy or latex-free Foley catheter to be placed
• Fetal death
• Anomalous fetus
• Placenta/vasa previa
• Placental abruption (known or suspected)
• Intrapartum bleeding
• Non-reassuring fetal tracing with following criteria: category III tracing, OR minimal variability AND decelerations of any kind, OR late decelerations occurring >50% of contractions
• 2 or more previous cesarean section, myomectomy, or classical cesarean
• Need to use ripening agents prior to Foley placement
• Spontaneous labor
• Active genital herpes
• Inability to consent
• Any contraindication to a vaginal delivery