Outpatient Labor Induction With the Transcervical Foley Balloon

Outpatient Labor Induction With the Transcervical Foley Balloon: A Randomized Trial Comparing Outpatient Immediate Removal Foley Versus Standard Inpatient Foley Induction

This study represents the first randomized trial comparing traditional inpatient induction with a transcervical foley catheter versus outpatient induction with immediate removal of a transcervical foley catheter. The immediate removal technique allows the induction process to begin in the hospital setting, but allows the patient to go home without a foreign body in situ. The investigators hypothesize the outpatient group will spend less time hospitalized prior to discharge. Additionally, the investigators will explore the vaginal delivery rates and maternal/neonatal safety profiles between groups.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Labor; Forced or Induced, Affecting Fetus or Newborn
• Intervention / Treatment: Device: inpatient Foley balloon induction; Drug: Oxytocin; Device: outpatient Foley balloon induction

Detailed Description

This is a randomized controlled trial.

Patients who are candidates for labor induction and meet inclusion criteria will be identified in the obstetrics clinic when they are being scheduled for induction of labor, or at a later clinic date. If they agree to participate, patients will be randomized and enrolled in the study at that time. Those who consent will be randomized into Group A (Experimental Group) and Group B (Control Group). No stratification criteria will be used.

Patients randomized to the control group will undergo induction of labor using the standard foley bulb and Pitocin method. Participants will be placed in the dorsal lithotomy position, an 18 French Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.

Patients randomized to the experimental group will undergo outpatient induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per protocol.

In accordance with the Friedman curve and current LAC+USC practice, primigravid participants will be given 20 hours of maximum Pitocin (22 mU/ min) to achieve active labor and multigravid participants will be given 14 hours before a failed induction is diagnosed. Cesarean delivery will be recommended for arrest of dilation, arrest of descent, or any obstetric indication as decided by the on-duty house staff. Finally, at patient request, intravenous or regional anesthesia will be made available at any time during the labor and delivery process.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Los Angeles County + University of Southern California Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Viable Intrauterine Pregnancy
• Greater than or equal to 37 weeks gestation on date of induction
• Cephalic Presentation
• Medically indicated induction of labor
• AFI greater than or equal to 5
• Patient able to be contacted by phone and demonstrates an understanding of the return instructions
• Cervical Dilation 2cm or less

Exclusion Criteria:

• Placenta Previa/Low Lying Placenta
• Placenta accreta/increta/percreta
• Undiagnosed vaginal bleeding
• Preeclampsia or HELLP Syndrome
• Intrauterine Growth Restriction
• Rupture of Membranes
• Prior cesarean section or transfundal uterine surgery
• Twin Gestation
• Fetal Anomaly
• Rh Isoimmunization
• Fetal Demise
• Uterine Tachysystole
• Less than 18 years of age
• HIV Infection
• Active herpes, hepatitis B or C infection
• Latex Allergy
• EFW>4000g
• Chorioamnionitis
• Non-English or Non-Spanish Speaking

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: inpatient Foley balloon induction; Inpatient Foley induction participants will be placed in the dorsal lithotomy position, a Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.	Device: inpatient Foley balloon induction; The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.; Other Names: 18-French Bard catheter; Drug: Oxytocin; When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol. Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement.
Experimental: outpatient Foley balloon induction; Patients randomized to the experimental group will undergo outpatient Foley induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.	Drug: Oxytocin; When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol. Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement.; Device: outpatient Foley balloon induction; The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours.; Other Names: 18-French Bard catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of inpatient hospitalization (hours)	compare inpatient time as measured by time from admission to time to discharge between the control (standard transcervical foley balloon placement/inpatient procedure) and the experimental group (immediate removal transcervical foley balloon placement/outpatient procedure)	time from hospital admission to time to discharge, on average 96 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of labor induction (hours)	time of initiation of labor induction to delivery, on average 24 hours
Cesarean section rate (percentage)	determined at time of delivery
Duration of oxytocin use during labor induction (hours)	time of initiation of oxytocin until it is discontinued, on average 18 hours
Rate of patients having prolonged fetal heart rate decelerations during labor induction (percentage)	from initiation of labor induction to delivery, on average 24 hours
Rate of patients developing chorioamnionitis during labor induction (percentage)	from initiation of induction until delivery, on average 24 hours
Rate of patients developing uterine tachysystole during labor induction (percentage)	from initiation of labor induction to delivery, on average 24 hours
Rate of infants admitted to NICU (percentage)	on average during the 24 hours following delivery
APGAR score	at 1 minute, 5 minutes, and 10 minutes after delivery

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Study Director: Patrick M Mullin, MD, University of Southern California; Principal Investigator: Yen Chan, MD, University of Southern California; Study Director: Richard Lee, MD, University of Southern California

Publications and helpful links

General Publications

• Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
• Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
• Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
• Kelly AJ, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007372. doi: 10.1002/14651858.CD007372.pub2.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: oxytocin; Cesarean section; catheter; labor, induced
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: HS-13-00740