Induction of Labor Clinical Trial
Official title:
A Randomized Control Trial of Foley Catheter Placement for Induction of Labor: Stylette Versus no Stylette
Verified date | March 2024 |
Source | Aurora Health Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 134 |
Est. completion date | December 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Aurora Sinia Medical Center | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Marie Forgie | Aurora Health Care |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Failure Rates of the Placement of a Foley Catheter | 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 | Followed throughout patient's hospital stay, approximately 10 days | |
Primary | 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 | Pain Assessed by Visual Analog Scale (VAS) | 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. | Followed throughout patient's hospital stay, approximately 10 days |
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