Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

Phase 4

Completed

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

Interventions: Device: Transcervical Foley catheter
Drug: Oxytocin

Registration Number: NCT02273115

Lead Sponsor: Christiana Care Health Services

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 323

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nulliparous - Foley only	Transcervical Foley catheter	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.
Nulliparous - Foley and oxytocin	Transcervical Foley catheter	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.
Multi(primi)parous - Foley and oxytocin	Transcervical Foley catheter	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.
Multi(primi)parous - Foley only	Transcervical Foley catheter	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.
Nulliparous - Foley and oxytocin	Oxytocin	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.
Multi(primi)parous - Foley and oxytocin	Oxytocin	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.

Primary Outcome Measures

Name	Time	Method
Delivery Rate	Within 24 hours	The rate of women who deliver in less than or equal to 24 hours from Foley placement.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Time to Delivery Achieved Within 12 Hours	Within 12 hours	Number of participants with a time from Foley placement to delivery less than or equal to 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	Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours	Regional analgesia used during Foley ripening
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

Trial Locations

Locations (2): Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Christiana Care Health Services
🇺🇸
Newark, Delaware, United States