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Combined Spinal Epidural Urinary Retention

This study has been terminated.
(Change in procedure.US technically challenging.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01597791
First Posted: May 14, 2012
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeanette Bauchat, Northwestern University
  Purpose
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.

Condition Intervention
Anesthesia Pain Urinary Retention Device: Foley catheter Other: No foley catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Do Women Receiving Low Dose Combined Spinal Epidural for Labor Analgesia Exhibit Less Bacteriuria Using a Urinary Retention Protocol Versus Routine Urinary Catheter Placement?

Resource links provided by NLM:


Further study details as provided by Jeanette Bauchat, Northwestern University:

Primary Outcome Measures:
  • Rate of Positive Urine Culture (Bacteriuria) [ Time Frame: 48 Hours ]
    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 in a woman immediately


Enrollment: 56
Actual Study Start Date: March 22, 2012
Study Completion Date: December 1, 2016
Primary Completion Date: December 1, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Foley catheter
Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.
Device: Foley catheter
Foley catheter placement after CSE.
Experimental: No Foley Catheter
Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.
Other: No foley catheter
Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nulliparous
  • Term (≥37 week gestation)
  • Healthy
  • ASA class 1-2
  • Who are being induced for labor who request labor analgesia and who successfully receive standard combined spinal epidural analgesia (verbal rating score for pain ≤ 1 after 10 min)

Exclusion Criteria:

  • Women with ASA 3 or greater
  • BMI ≥40 kg/m2
  • Prior history of urge or stress incontinence or urinary retention before pregnancy
  • Women with a history of nephrolithiasis
  • Chronic urinary tract infections
  • Women whose post-void residual volume as assessed by ultrasonography is found to be >100ml before epidural placement will be excluded.
  • Women with an absolute or relative contraindication to the usual combined spinal epidural technique
  • Failed analgesia will be excluded
  • Women for whom the anesthesiologist selects an analgesic technique other than combined spinal epidural technique or fail to obtain CSF for CSE will be excluded
  • Women with fetal heart rate decelerations before request for analgesia will be excluded due to increased risk of cesarean delivery.
  • Women who experience inadequate labor analgesia due to nonfunctioning epidural catheter necessitating epidural replacement will be included but noted as a protocol violation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597791


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jeanette Bauchat, M.D. Northwestern University
  More Information

Responsible Party: Jeanette Bauchat, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01597791     History of Changes
Other Study ID Numbers: STU00005516
First Submitted: May 10, 2012
First Posted: May 14, 2012
Results First Submitted: September 12, 2017
Results First Posted: October 10, 2017
Last Update Posted: October 10, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeanette Bauchat, Northwestern University:
Urinary Retention
Urinary Catheter
Bacteriuria

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases