An interventional study of Indwelling catheter and Intermittent straight catheterization in Labor, sponsored by Loyola University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by Loyola University · Not applicable, Interventional, and Treatment
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.
Loyola University is the lead sponsor of 132 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
Procedure: Indwelling catheter
Intermittent straight catheterization will be performed as needed during labor.
Procedure: Intermittent straight catheterization
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.
Time to Delivery (by Any Route)
Time to delivery defined as IV placement to delivery of infant.
Time frame: 1 day
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.
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.
| Milestone | Indwelling Foley Catheter | Intermittent Straight Catheterization |
|---|---|---|
| Started | 72 | 67 |
| Completed | 72 | 66 |
| Not completed | 0 | 1 |
Time to delivery defined as IV placement to delivery of infant.
| Hours | Indwelling Foley Catheter | Intermittent Straight Catheterization |
|---|---|---|
| Time to Delivery (by Any Route) | 10.43 (5.52 to 15.34) | 11.23 (7.15 to 15.31) |
Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Indwelling Foley Catheter | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Intermittent Straight Catheterization | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Age, Categorical(Participants) | Indwelling Foley Catheter | Intermittent Straight Catheterization | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 72 | 67 | 139 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Indwelling Foley Catheter | Intermittent Straight Catheterization | Total |
|---|---|---|---|
| Mean | 27.6 ± 6 | 28.7 ± 6 | 28.14 ± 6.13 |
| Sex: Female, Male(Participants) | Indwelling Foley Catheter | Intermittent Straight Catheterization | Total |
|---|---|---|---|
| Female | 72 | 67 | 139 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Indwelling Foley Catheter | Intermittent Straight Catheterization | Total |
|---|---|---|---|
| United States | 72 | 67 | 139 |
Plan to share: No
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Loyola University