NCT02273115

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Christiana Care Health Services · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Labor; Forced or Induced, Affecting Fetus or Newborn

Interventions

Type	Name	Description
DRUG	Oxytocin
DEVICE	Transcervical Foley catheter

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-09-11
• Completion: 2016-09-11
• First posted: 2014-10-23
• Last updated: 2017-07-02
• Results posted: 2017-06-05

Locations

2 sites across 1 country: United States