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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ placement of foley balloon until cesarean delivery if applicable
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~placement of foley balloon until cesarean delivery if applicable
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 moreAwards & 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.
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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