A Randomized Control Trial of Foley Catheter Placement for Induction of Labor: Stylette Versus no Stylette
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 134
- Locations
- 2
- Primary Endpoint
- Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.
Study Overview
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.
Detailed Description
Outcomes:
Primary Outcome Measures:
• The duration of insertion between the Foley catheter groups with and without a stylette.
Secondary Outcome Measures:
• Pain assessed by visual analogue scale (VAS), in women randomly allocated to rigid stylette or no rigid stylette placement of a Foley catheter for induction of labor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Stylette
Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.
Intervention: Stylette (Device)
No Stylette
No Stylette: 22 French Foley catheter placed without stylette or guide.
Outcomes
Primary Outcomes
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 Outcomes
- Pain Assessed by Visual Analog Scale (VAS)(Followed throughout patient's hospital stay, approximately 10 days)