Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor; Forced or Induced, Affecting Fetus or Newborn

Intervention / Treatment
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* Drug: Oxytocin
* Device: Transcervical Foley catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nulliparous - Foley only<br>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. | Device: Transcervical Foley catheter<br> <br> * Other names: Transcervical Foley balloon;|
| Active Comparator: Nulliparous - Foley and oxytocin<br>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. | Drug: Oxytocin<br> <br> Device: Transcervical Foley catheter<br> <br> * Other names: Transcervical Foley balloon;|
| Active Comparator: Multi(primi)parous - Foley only<br>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. | Device: Transcervical Foley catheter<br> <br> * Other names: Transcervical Foley balloon;|
| Active Comparator: Multi(primi)parous - Foley and oxytocin<br>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. | Drug: Oxytocin<br> <br> Device: Transcervical Foley catheter<br> <br> * Other names: Transcervical Foley balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery Rate | The rate of women who deliver in less than or equal to 24 hours from Foley placement. | Within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Time to Delivery Achieved Within 12 Hours | Number of participants with a time from Foley placement to delivery less than or equal to 12 hours | Within 12 hours | 
| Total Time to Delivery |  | On average, 24-36 hours | 
| Time to Foley Expulsion |  | 0-12 hours | 
| Number of Vaginal Deliveries |  | Assessed after delivery, on average occurring between 24-48 hours | 
| Regional Analgesia | Regional analgesia used during Foley ripening | Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours | 
| Obstetric Complications |  | Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period | 
| Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 |  | Assessed from birth through discharge, on average 2 days after birth | 
| Neonatal Outcome: Neonatal Weight |  | Assessed from birth through discharge, on average 2 days after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction, Foley catheter, oxytocin