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Procedure
Outpatient Foley balloon placement for Pregnancy Outcomes (Balloon Trial)
N/A
Recruiting
Research Sponsored by Lehigh Valley Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Balloon Trial Summary
This trial is testing if outpatient cervical ripening for induction of labor at term can reduce length and cost of inpatient hospitalization.
Who is the study for?
This trial is for English-speaking pregnant women at least 39 weeks along, with a single baby in head-down position and no prior cesarean. They must have normal prenatal scans, live within an hour of the hospital, and be planning to induce labor. Excluded are those with certain health conditions or infections, previous uterine surgery contraindicating vaginal delivery, or needing continuous fetal monitoring.Check my eligibility
What is being tested?
The study compares two methods of preparing the cervix for childbirth in women who need labor induced: one group will have a Foley balloon placed while they're outpatients (at home), and another as inpatients (in the hospital). The goal is to see if outpatient placement reduces time spent in the hospital and costs.See study design
What are the potential side effects?
Potential side effects from Foley balloon placement may include discomfort during insertion, cramping or contractions after placement, possible bleeding or infection. However, these are generally considered safe procedures.
Balloon Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups.
The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery.
Secondary outcome measures
Birthweight
Cord PH
Delivery
+9 moreBalloon Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Outpatient cervical ripeningExperimental Treatment1 Intervention
Placement of transcervical Foley balloon for cervical ripening in outpatient setting
Group II: Inpatient cervical ripeningActive Control1 Intervention
Placement of transcervical Foley balloon for cervical ripening in inpatient setting
Find a Location
Who is running the clinical trial?
Lehigh Valley HospitalLead Sponsor
24 Previous Clinical Trials
16,315 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a new health issue that needs me to stay in the hospital.I am experiencing vaginal bleeding.I cannot have a baby through vaginal delivery due to medical reasons.I have a heart or lung condition that needs monitoring during childbirth.I do not speak English.My cervix is not very open or ready for labor according to my doctor's assessment.I require hospital stay or constant baby monitoring during labor preparation.I am 18 years old or older.I am pregnant and at least 39 weeks along, as confirmed by standard methods.I do not have HIV, Hepatitis C, or an active herpes infection.I have diabetes that existed before pregnancy or severe gestational diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Outpatient cervical ripening
- Group 2: Inpatient cervical ripening
Awards:
This trial has 1 awards, including:- 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.
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