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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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Cesarean Delivery
Secondary study objectives
Maternal morbidity incidence
Maternal overall length of stay
Maternal patient perception of control
+7 more
Other study objectives
Heterogeneity of Treatment Effect/prespecified sub-groups

Awards & Highlights

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 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

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,725,061 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

Outpatient Foley catheter (Cervical Ripening Device) Clinical Trial Eligibility Overview. Trial Name: NCT05759988 — N/A
Induction of Labor Research Study Groups: Outpatient cervical ripening with Foley, Standard of care Inpatient cervical ripening
Induction of Labor Clinical Trial 2023: Outpatient Foley catheter Highlights & Side Effects. Trial Name: NCT05759988 — N/A
Outpatient Foley catheter (Cervical Ripening Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05759988 — N/A
~1380 spots leftby Jun 2027
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