Labor
Conditions
Keywords
Indwelling bladder catheter, Intermittent straight catheterization, Labor and Delivery, Time to delivery during labor
Brief summary
The goal of this study is to compare two clinically-relevant bladder drainage techniques. This is a randomized controlled trial with a single primary outcome of time to delivery. The results will inform clinical decisions about method of catheterization during labor.
Detailed description
Urinary catheterization is a common practice during labor following placement of an epidural for pain control, as this form of anesthesia is known to inhibit normal bladder emptying. There is insufficient evidence to guide clinicians in selection of an indwelling catheter versus intermittent straight catheterization during the course of labor. The goal of this randomized control trial is to compare two clinically-relevant bladder drainage techniques.
Interventions
PROCEDUREIndwelling catheter
Indwelling bladder catheter will remain in place until time of delivery.
intermittent straight catheterization will be performed on an as needed basis until time of delivery.
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who present to either Loyola University Medical Center or Loyola at Gottlieb Hospital in active labor or for induction of labor with a singleton pregnancy and who are anticipated to undergo vaginal delivery during the current admission
Exclusion criteria
* Women who are undergoing a scheduled cesarean delivery * Women with a contraindication to either of the 2 study interventions * Multi-fetal gestations * Current or planned tocolysis * Women who are on magnesium prophylaxis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Delivery (by Any Route) | 1 day | Time to delivery defined as IV placement to delivery of infant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Cost Between the Two Interventions | End of study. | Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled 7/09-11/09 from the obstetric units of the Loyola University Health System hospitals. Subjects included adult women with a singleton pregnancy who presented to the Labor & Deliver in active labor or for induction, were anticipated to have an normal spontaneous vaginal delivery (NSVD), and had an epidural.
Pre-assignment details
Every patient was assigned to a group immediately following enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Indwelling Foley Catheter Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery. | 72 |
| Intermittent Straight Catheterization Intermittent straight catheterization will be performed as needed during labor. | 67 |
| Total | 139 |
Baseline characteristics
| Characteristic | Intermittent Straight Catheterization | Indwelling Foley Catheter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 72 Participants | 139 Participants |
| Age, Continuous | 28.7 years STANDARD_DEVIATION 6 | 27.6 years STANDARD_DEVIATION 6 | 28.14 years STANDARD_DEVIATION 6.13 |
| Region of Enrollment United States | 67 participants | 72 participants | 139 participants |
| Sex: Female, Male Female | 67 Participants | 72 Participants | 139 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 67 |
| other Total, other adverse events | 0 / 72 | 0 / 67 |
| serious Total, serious adverse events | 0 / 72 | 0 / 67 |
Outcome results
Primary
Time to Delivery (by Any Route)
Time to delivery defined as IV placement to delivery of infant.
Time frame: 1 day
Population: Our a priori sample size required 138 women (69 per group) for 80% power to detect the clinically relevant 30 minute difference in the time to delivery interval with a .05 alpha error.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Indwelling Foley Catheter | Time to Delivery (by Any Route) | 10.43 Hours |
| Intermittent Straight Catheterization | Time to Delivery (by Any Route) | 11.23 Hours |
Comparison: The null hypothesis is that patients for whom indwelling foley catheterization was employed will have their time to delivery interval reduced by 30 minutes.p-value: 0.42t-test, 2 sided
Secondary
Difference in Cost Between the Two Interventions
Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.
Time frame: End of study.
Population: No formal statistical testing was conducted on these measures as complete financial records were not available for the analysis.