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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indwelling foley catheter | Active Comparator | Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery. |
|
| Intermittent straight catheterization | Active Comparator | Intermittent straight catheterization will be performed as needed during labor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indwelling catheter | Procedure | Indwelling bladder catheter will remain in place until time of delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Delivery (by Any Route) | Time to delivery defined as IV placement to delivery of infant. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Cost Between the Two Interventions | Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars. | End of study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarita Massey, MD | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Health System | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22540248 | Derived | Rivard C, Awad M, Liebermann M, Dejong M, Massey SM, Sinacore J, Brubaker L. Bladder drainage during labor: a randomized controlled trial. J Obstet Gynaecol Res. 2012 Aug;38(8):1046-51. doi: 10.1111/j.1447-0756.2011.01837.x. Epub 2012 Apr 30. |
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Every patient was assigned to a group immediately following enrollment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Intermittent Straight Catheterization | Intermittent straight catheterization will be performed as needed during labor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intermittent Straight Catheterization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Delivery (by Any Route) | Time to delivery defined as IV placement to delivery of infant. | 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. | Posted | Median | Inter-Quartile Range | Hours | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The are not limitations or caveats to disclose.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarita Massey | Loyola University Medical Center | 708-354-9250 | smassey@lumc.edu |
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| ID | Term |
|---|---|
| D002408 | Catheters, Indwelling |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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| Intermittent straight catheterization | Procedure | intermittent straight catheterization will be performed on an as needed basis until time of delivery. |
|
Intermittent straight catheterization will be performed as needed during labor.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Difference in Cost Between the Two Interventions | Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars. | No formal statistical testing was conducted on these measures as complete financial records were not available for the analysis. | Posted | End of study. |
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Intermittent Straight Catheterization | Intermittent straight catheterization will be performed as needed during labor. | 0 | 67 | 0 | 67 | 0 | 67 |
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