N/A
N=134
Foley Catheter for Induction of Labor
Foley Catheterization · Induction of Labor · 5 French Stylette
Bottom Line
View on ClinicalTrials.gov: NCT02044458 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Duration of Insertion Between Foley Catheter Groups With and Without a Stylette. — 1.72; 1.88; 6.55; 5.00 minutes — p=.70
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stylette (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Insertion Between Foley Catheter Groups With and Without a Stylette. |
1.72; 1.88; 6.55; 5.00 | .70 |
| SECONDARY Pain Assessed by Visual Analog Scale (VAS) |
4.90; 4.43 | .38 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02044458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.