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Cervical Ripening Device
Outpatient Foley Catheter for Induction of Labor (COMFORT Trial)
N/A
Recruiting
Led By Lisa Levine, MD, MSCE
Research Sponsored by University of Pennsylvania
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 within 6 weeks of delivery
Awards & highlights
COMFORT Trial Summary
This trial aims to test if outpatient cervical ripening with a Foley catheter can reduce the rate of Cesarean Delivery and maternal/neonatal complications in nulliparous women undergoing term induction.
Who is the study for?
The COMFORT trial is for first-time pregnant women at term (37-42 weeks) who need labor induced and meet specific health criteria. They must have an intact amniotic sac, baby in head-down position, a low Bishop score indicating the cervix isn't very dilated or ready for labor, speak English or Spanish, have safe housing and transportation to return to the hospital.Check my eligibility
What is being tested?
This study compares two ways of preparing the cervix for labor induction in nulliparous women: using a Foley catheter at home (outpatient) versus the standard method done in the hospital (inpatient). The goal is to see if outpatient ripening lowers Cesarean delivery rates and improves mother/baby health outcomes.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from having a Foley catheter placed inside the cervix, possible infection risk due to wearing it outside of a sterile environment like a hospital, and complications that require urgent medical attention.
COMFORT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Cesarean Delivery
Secondary outcome measures
Maternal morbidity incidence
Maternal overall length of stay
Maternal patient perception of control
+7 moreOther outcome measures
Heterogeneity of Treatment Effect/prespecified sub-groups
COMFORT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Outpatient cervical ripening with FoleyExperimental Treatment1 Intervention
Cervical ripening will begin with a Foley balloon in the outpatient setting
Group II: Standard of care Inpatient cervical ripeningActive Control1 Intervention
Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,879,909 Total Patients Enrolled
Lisa Levine, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvaina
1 Previous Clinical Trials
164 Total Patients Enrolled
Alison Cahill, MD, MSCIPrincipal InvestigatorUniversity of Texas at Austin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have sickle cell disease.I have severe, long-term high blood pressure.I have had vaginal bleeding or concerns about placental separation before a medical procedure.I have Type 1 diabetes or my pre-pregnancy diabetes is not well-controlled.I can read and understand English or Spanish.I am pregnant with one baby, between 37 and 41 weeks along.I am a woman currently on blood thinners.I am over 18 and have never given birth to a child.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: Outpatient cervical ripening with Foley
- Group 2: Standard of care 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.
Does the research study accept volunteers aged 18 and above?
"Patients aged between 18 and 60 are eligible to enroll in this clinical trial. Conversely, there exist 1 separate study for underage individuals, while those over the age of 65 can join 4 distinct trials."
Answered by AI
Are there multiple locations offering this clinical trial within the state's borders?
"This medical research is being conducted in four locations: University of Pennsylvania, Philadelphia; the University of Texas at Austin; the University of Utah, Salt Lake City; and other sites."
Answered by AI
Am I a viable candidate to partake in this research study?
"This medical experiment requires that individuals have gone through the process of childbirth and be within an age range between 18 to 60. The total number of participants sought is 2,300."
Answered by AI
Are there currently any open spots for participation in this trial?
"Clinicaltrials.gov states that this particular research is not in search of participants, despite its initial posting on March 6th 2023 and the later edit on March 7th 2023. Nevertheless, there are 6 other clinical trials actively looking for volunteers as we speak."
Answered by AI
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