Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX)

Christiana Care Health Services

Status and phase: Completed; Phase 4

Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn

Treatments: Device: Transcervical Foley catheter; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02273115

CCC-34107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 323 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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323 participants in 4 patient groups

Nulliparous - Foley only

Active Comparator group

Description:

Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.

Treatment:

Device: Transcervical Foley catheter

Nulliparous - Foley and oxytocin

Active Comparator group

Description:

Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.

Treatment:

Drug: Oxytocin

Device: Transcervical Foley catheter

Multi(primi)parous - Foley only

Active Comparator group

Description:

Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.

Treatment:

Device: Transcervical Foley catheter

Multi(primi)parous - Foley and oxytocin

Active Comparator group

Description:

Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.

Treatment:

Drug: Oxytocin

Device: Transcervical Foley catheter