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Placement of Foley balloon for cervical ripening without tension. for Vaginal Birth After Cesarean (VBAC)

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

Study 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

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

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
244 Previous Clinical Trials
56,471 Total Patients Enrolled
Meagan V Benson, DOPrincipal InvestigatorUniversity of Texas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any particular demographics that are ideal for this experiment?

"Potential participants in this trial should have undergone an induced vaginal delivery and exhibit ages between 18 to 50 years old. The study is targeting a cohort of approximately 260 individuals."

Answered by AI

What is the current enrollment rate for this medical study?

"Indeed, clinicaltrials.gov confirms that the trial is actively recruiting and has been since June 3rd 2022. The study seeks 260 participants at one site for enrollment."

Answered by AI

Is the enrollment for this clinical research confined to individuals below forty years of age?

"This clinical trial is recruiting participants who are between 18 and 50 years old."

Answered by AI

Are additional participants being enrolled in this medical experiment?

"The details hosted on clinicaltrials.gov verify that this trial is still in the recruitment stage, with first notice posted June 3rd and last edit made 6th of the same month."

Answered by AI
Recent research and studies
Obstetrics & GynecologyJournal
Evaluation of a Transcervical Foley Catheter as a Source of Infection
McMaster, Kristen, Luis Sanchez-Ramos, and Andrew M. Kaunitz. 2015. “Evaluation of a Transcervical Foley Catheter as a Source of Infection”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000001002.
American Journal of Obstetrics and GynecologyJournal
A Randomized Trial of Foley Balloon Induction of Labor Trial in Nulliparas (FIAT-N)
Connolly, Katherine A., Katherine S. Kohari, Patricia Rekawek, Brooke S. Smilen, Meredith R. Miller, Erin Moshier, Stephanie H. Factor, Joanne L. Stone, and Angela T. Bianco. 2016. “A Randomized Trial of Foley Balloon Induction of Labor Trial in Nulliparas (FIAT-N)”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2016.03.034.
Obstetrics & GynecologyJournal
Intracervical Foley Catheter with and Without Oxytocin for Labor Induction
Schoen, Corina N., Gwendolyn Grant, Vincenzo Berghella, Matthew K. Hoffman, and Anthony Sciscione. 2017. “Intracervical Foley Catheter with and Without Oxytocin for Labor Induction”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002032.
Obstetrics & GynecologyJournal
Foley Bulb Added to an Oral Misoprostol Induction Protocol
Adhikari, Emily H., David B. Nelson, Donald D. McIntire, and Kenneth J. Leveno. 2020. “Foley Bulb Added to an Oral Misoprostol Induction Protocol”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000004123.
~89 spots leftby May 2025
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