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Tension Versus Tension- Free Foley Balloon for Cervical Ripening

N/A
Waitlist Available
Led By Meagan V Benson, DO
Research Sponsored by The University of Texas Medical Branch, Galveston
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 placement of foley balloon until delivery
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether or not a Foley balloon, a common device used to induce labor, is more effective when placed under tension.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~placement of foley balloon until cesarean delivery if applicable
This trial's timeline: 3 weeks for screening, Varies for treatment, and placement of foley balloon until cesarean delivery if applicable for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to vaginal delivery
Secondary study objectives
Incidence of chorioamnionitis
Incidence of postpartum hemorrhage
Incidence of primary cesarean delivery
+1 more

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: Without tension (tension free)Experimental Treatment1 Intervention
The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Group II: TensionActive Control1 Intervention
The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
254 Previous Clinical Trials
56,995 Total Patients Enrolled
Meagan V Benson, DOPrincipal InvestigatorUniversity of Texas
~74 spots leftby Dec 2025