Recruiting

Foley Catheter vs. Foley Catheter

Sponsor:

University of Southern California

Code:

NCT02210598

Conditions

Pregnancy

Labor; Forced or Induced, Affecting Fetus or Newborn

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

inpatient Foley balloon induction

outpatient Foley balloon induction

Oxytocin

Study Details

Brief summary:

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.

Conditions

Pregnancy

Labor; Forced or Induced, Affecting Fetus or Newborn

Study ID

NCT02210598

Start date

Mar, 2014

Status verified date

Apr, 2017

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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.

Primary outcome measure

  • Duration of inpatient hospitalization (hours) [ Time Frame: time from hospital admission to time to discharge, on average 96 hours ]

Central Contacts and Locations

Central contacts

Patrick M Mullin, MD

pmullin@usc.edu

Locations

Los Angeles County + University of Southern California Medical Center

Recruiting

Los Angeles, California, United States, 90033

More Information

Sponsor

University of Southern California

Last update posted

Apr 19, 2017

Last verified

Apr, 2017

Keywords

  • labor, induced
  • catheter
  • oxytocin
  • Cesarean section

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2017-04-19.