Foley Catheter for Induction of Labor

NCT02044458 | Completed Results

• 1 other identifier: #13-46E :Foley Catheter
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Foley Catheterization; Induction of Labor; 5 French Stylette

Keywords

Foley Catheterization; Induction of Labor; 5 French Stylette

Outcome Measures

Primary Outcomes (1)

• Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.

  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).

  Followed throughout patient's hospital stay, approximately 10 days

Secondary Outcomes (1)

• Pain Assessed by Visual Analog Scale (VAS)

  Followed throughout patient's hospital stay, approximately 10 days

Other Outcomes (1)

• Failure Rates of the Placement of a Foley Catheter

  Followed throughout patient's hospital stay, approximately 10 days

Study Arms (2)

Stylette

ACTIVE COMPARATOR

Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.

Device: Stylette

No Stylette

NO INTERVENTION

No Stylette: 22 French Foley catheter placed without stylette or guide.

Interventions

Stylette DEVICE

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

Also known as: 5 French stylette, Rigid catheter guide, Urethral manipulator (TVT procedure)

Stylette

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora Sinia Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

Limitations and Caveats

Did not enroll enough subjects to achieve sufficient power for every test performed or to study outcomes with low event rates. Insertion time and failure may be influenced by providers comfort with insertion technique. Women were from a single site.

Results Point of Contact

• Title: Jessica J F Kram, MPH
• Organization: Aurora Health Care, Inc.

jessica.kram@aurora.org

414-219-5594

Study Officials

• Danish S Siddiqui, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: January 24, 2014
• Study Start: April 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 3, 2024
• Results First Posted: August 26, 2016

Record last verified: 2024-03

Locations

US (1)