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Device

Outpatient vs Inpatient Foley Balloon for Labor Induction

Los Angeles, CA

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

Must not have

Active herpes, hepatitis B or C infection

Non-English or Non-Spanish Speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from hospital admission to time to discharge, on average 96 hours

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active herpes, hepatitis B or C.

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I do not speak English or Spanish.

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I am experiencing vaginal bleeding that has not been diagnosed.

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I have had a C-section or surgery on my uterus.

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I am HIV positive.

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I am under 18 years old.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from hospital admission to time to discharge, on average 96 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of inpatient hospitalization (hours)

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 6Eligibility criteria met