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Outpatient vs Inpatient Foley Balloon for Labor Induction
N/A
Waitlist Available
Led By Yen Chan, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 minute, 5 minutes, and 10 minutes after delivery
Awards & highlights
Study Summary
This trial is testing whether it's better to induce labor in the hospital with a transcervical foley catheter, or to do it outpatient with removal of the transcervical foley catheter. The goal is to see if the outpatient group spends less time in the hospital.
Who is the study for?
This trial is for pregnant individuals at or beyond 37 weeks with a head-down baby, needing labor induction, and a cervix not more than slightly dilated. They must understand return instructions and be reachable by phone. Excluded are those under 18, with certain placenta issues, preeclampsia, ruptured membranes, prior cesarean section or uterine surgery, twins, specific infections (HIV/herpes/hepatitis), latex allergy or if the estimated fetal weight is over 4000g.Check my eligibility
What is being tested?
The study compares two ways to induce labor: traditional in-hospital Foley balloon induction versus outpatient induction where the balloon is removed before going home. The goal is to see if outpatient care reduces hospital time without compromising safety and effectiveness of vaginal delivery rates.See study design
What are the potential side effects?
Potential side effects may include discomfort from the Foley catheter placement and removal process. There's also a risk of infection or inducing too-strong contractions (tachysystole). Oxytocin can cause intense contractions leading to fetal distress or changes in heart rate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from hospital admission to time to discharge, on average 96 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from hospital admission to time to discharge, on average 96 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of inpatient hospitalization (hours)
Secondary outcome measures
APGAR score
Cesarean section rate (percentage)
Duration of labor induction (hours)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: outpatient Foley balloon inductionExperimental Treatment2 Interventions
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.
Group II: inpatient Foley balloon inductionActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,595,985 Total Patients Enrolled
Yen Chan, MDPrincipal InvestigatorUniversity of Southern California
Richard Lee, MDStudy DirectorUniversity of Southern California
5 Previous Clinical Trials
1,400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active herpes, hepatitis B or C.The baby's head is positioned downward in the mother's womb.I do not speak English or Spanish.You need to have labor induced for medical reasons.I am experiencing vaginal bleeding that has not been diagnosed.You are allergic to latex.I have had a C-section or surgery on my uterus.I am HIV positive.Your cervix is not dilated more than 2 centimeters.I can be reached by phone and understand how to follow instructions.You have a condition called placenta previa or low-lying placenta.You have a condition called placenta accreta, increta, or percreta.I am under 18 years old.You have a condition called preeclampsia or HELLP Syndrome during pregnancy.You have a condition called Intrauterine Growth Restriction, which means that you did not grow properly in the womb.Your water has broken.You are pregnant and your baby has a condition that affects their development.You have experienced the loss of an unborn baby.
Research Study Groups:
This trial has the following groups:- Group 1: inpatient Foley balloon induction
- Group 2: outpatient Foley balloon induction
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are actively engaged in this clinical research project?
"This trial is not currently accepting new participants. It was initially uploaded to the database on March 1st 2014 and last modified on April 17th 2017. If you are considering alternative studies, there are 79 trials recruiting patients in a pregnant state and 53 conducting outpatient Foley balloon induction treatment that have open enrolment slots."
Answered by AI
What medical conditions necessitate outpatient Foley balloon induction?
"Hemorrhage can be effectively managed using outpatient Foley balloon induction therapy. This method of treatment has also been used to help with labour, uterine contractions and the augmentation of labor."
Answered by AI
Is there any availability for prospective participants in this clinical experiment?
"Unfortunately, this clinical trial is not accepting any new participants. The first posting date was March 1st 2014 and the last update was April 17th 2017. For those seeking other opportunities, there are 79 studies recruiting pregnant individuals and 53 trials looking for volunteers to participate in Foley balloon induction outpatient procedures."
Answered by AI
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