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Foley Catheter for Induction of Labor

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ClinicalTrials.gov Identifier: NCT02044458
Recruitment Status : Completed
First Posted : January 24, 2014
Results First Posted : August 26, 2016
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Aurora Health Care
Information provided by (Responsible Party):
Marie Forgie, Aurora Health Care

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Foley Catheterization Induction of Labor 5 French Stylette Device: Stylette Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of Foley Catheter Placement for Induction of Labor: Stylette Versus no Stylette
Study Start Date : April 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Stylette
Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.
 Device: Stylette
use of stylette for successful insertion of foley catheter for induction of labor
Other Names:
  • 5 French stylette
  • Rigid catheter guide
  • Urethral manipulator (TVT procedure)
No Intervention: No Stylette
No Stylette: 22 French Foley catheter placed without stylette or guide.


Outcome Measures
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Primary Outcome Measures :
  1. Duration of Insertion Between Foley Catheter Groups With and Without a Stylette. [ Time Frame: Followed throughout patient's hospital stay, approximately 10 days ]
    Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).


Secondary Outcome Measures :
  1. Pain Assessed by Visual Analog Scale (VAS) [ Time Frame: Followed throughout patient's hospital stay, approximately 10 days ]
    To compare the pain assessed by visual analogue scale(VAS), in women randomly allocated to ridged stylette or no ridged stylette. Patient-assessed pain level was determined by verbally asking patients to assess their pain (on a scale from 0-10 [no pain-worst pain]) following taping of the catheter tail. Pain was only assessed once.


Other Outcome Measures:
  1. Failure Rates of the Placement of a Foley Catheter [ Time Frame: Followed throughout patient's hospital stay, approximately 10 days ]
    To compare the failure rate of the placement of a Foley catheter for the induction of labor in women randomly allocated to rigid stylette or no stylette


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton fetus
  • Cephalic presentation
  • Indicated or Post-Estimated Date of Confinement
  • Induction of labor with a Bishop score < 5

Exclusion Criteria:

  • Low lying placenta
  • Undiagnosed vaginal bleeding
  • History of induction or pre-induction agent during the same pregnancy
  • Signs or symptoms of infection (i.e. Maternal fever)
  • Rupture of membranes
  • Multiple gestation
  • Women with an urgent or emergent clinical situation in which the medical staff caring for the patient determines that obtaining consent would interfere with the patient's clinical care
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044458


Locations
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United States, Wisconsin
Aurora Sinia Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Marie Forgie
Aurora Health Care
Investigators
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Principal Investigator: Danish S Siddiqui, MD Aurora Health Care
More Information
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Responsible Party: Marie Forgie, DO, Clinical Adjunct Professor- Department of Obstetrics and Gynecology, University of Wisconsin School of Medicine and Public Health, Aurora Sinai Medical Center, Department of Obstetrics and Gynecology, Women's Health Center, Aurora Health Care
ClinicalTrials.gov Identifier: NCT02044458    
Other Study ID Numbers: #13-46E :Foley Catheter
First Posted: January 24, 2014    Key Record Dates
Results First Posted: August 26, 2016
Last Update Posted: May 14, 2019
Last Verified: April 2019
Keywords provided by Marie Forgie, Aurora Health Care:
Foley Catheterization
Induction of Labor
5 French Stylette