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Transcervical Foley Catheter for Premature Rupture of Fetal Membranes

N/A
Waitlist Available
Led By Alan T Tita, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from induction to delivery
Awards & highlights

Summary

In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.

Eligible Conditions
  • Premature Rupture of Fetal Membranes
  • Induced Labor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of induction to 24 hours post start of induction
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of induction to 24 hours post start of induction for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hours From Placement of Foley or Initiation of Oxytocin to Delivery
Secondary outcome measures
Cesarean Rate
Induction to Vaginal Delivery Interval
Rate of Delivery (Vaginal or Cesarean)by 24 Hours

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transcervical Foley CatheterExperimental Treatment1 Intervention
Group II: No FoleyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcervical Foley catheter
2018
Completed Phase 4
~450

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,806 Total Patients Enrolled
Alan T Tita, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
~9 spots leftby Sep 2025
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