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NCT01597791 · ClinicalTrials.gov registry record · NA
Combined Spinal Epidural Urinary Retention
A NA study, sponsored by Northwestern University.
- Terminated
- Registry status
- NA
- Development phase
- 56
- Enrollment target
NCT01597791: Clinical Trial NA study, sponsored by Northwestern University.
NCT01597791 is a NA study that was terminated before completion, run by Northwestern University. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01597791, a NA study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
Study Summary
The investigators hypothesize that many parturients can, in fact, spontaneously micturate with low dose combined spinal epidural analgesic doses given for labor and that Foley catheterization is unnecessary in the majority of these parturients. At Prentice Women's Hospital, almost 9000 women annually receive neuraxial labor analgesia and 98% of those receive Foley catheters. By potentially reducing the necessity for Foley catheters, the investigators should be able to ultimately reduce the rate of bacteriuria, urinary tract infections and urethritis leading to unnecessary treatment with antibiotics, as well as reduce costs of placing unnecessary Foley catheter.The hypothesis is parturients receiving low dose combined spinal epidural analgesia for analgesia after induction of labor who are randomized to a spontaneous micturition protocol will require fewer Foley catheter placements and demonstrate a lower incidence of positive urine culture postpartum than those who undergo standard Foley catheter placement.
Primary Outcome
This study will be assessed by collecting a twenty-four to forty-eight hour midstream urine sample and performing a urine culture. The clinical and laboratory criteria used to define a urinary tract infection.
Interventions
- OTHER No foley catheter
- DEVICE Foley catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-03-22 |
| Est. Completion | 2016-12-01 |
| Phase | NA |
Why NCT01597791 stopped before completion
NCT01597791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which No foley catheter is the first listed.
NCT01597791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01597791 about?
NCT01597791 is a clinical study titled "Combined Spinal Epidural Urinary Retention". The investigators hypothesize that many parturients can, in fact, spontaneously micturate with low dose combined spinal epidural analgesic doses given for labor and that Foley catheterization is unnecessary in the majority of these parturients. At Prentice Women's Hospital, almost 9000 women annuall...
What is the current status of trial NCT01597791?
This trial is currently terminated. It is a NA study. The enrollment target is 56 participants. The study started on 2012-03-22. Estimated completion is 2016-12-01.
What interventions are being tested in trial NCT01597791?
The interventions under investigation include: No foley catheter (OTHER), Foley catheter (DEVICE).
Who is sponsoring clinical trial NCT01597791?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01597791's enrollment target sits among peer trials
56 1262nd of 2000 higher than 737 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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