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Foley Catheter for Induction of Labor

NCT02044458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-10-03

Study results available
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Summary

Study Design:

Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Detailed Description

The utilization of a Foley catheter for induction of labor is well established. There are two techniques readily used for placing a Foley catheter. The most common method is under direct visualization of the cervix during a sterile speculum examination and the other method is to place a catheter during a digital cervical examination.

Studies have reported the use of a rigid stylette (a thin wire inserted into a catheter to maintain rigidity) to guide the insertion of the Foley catheter decreases failure rate. The Foley catheter plus rigid stylette technique seems to be an efficient and safe method for labor induction. However, to our knowledge there is no study that assesses the difference between the standard digital placement of a Foley catheter versus the digital placement of a Foley catheter with stylette.

Conditions

  • Foley Catheterization
  • Induction of Labor
  • 5 French Stylette

Interventions

DEVICE

Stylette

use of stylette for successful insertion of foley catheter for induction of labor

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Danish S Siddiqui, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-03-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02044458 on ClinicalTrials.gov