Text Size

Combined Spinal Epidural Urinary Retention

This study is currently recruiting participants.
Verified December 2012 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Jeanette Bauchat, Northwestern University
ClinicalTrials.gov Identifier:
NCT01597791
First received: May 10, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  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 placement
Other: Spontaneous Micturation/ Post Void Residual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Rate of positive urine culture [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control group 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 placement
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: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597791

Contacts
Contact: Jeanette Bauchat, M.D. 312-472-3539 jbauchat@nmff.org
Contact: Robert McCarthy, PharmD 312-926-9015 r-mccarthy@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jeanette Bauchat, M.D.     312-472-3585     jbauchat@nmff.org    
Contact: Robert McCarthy, PharmD     321-472-3539     r-mccarthy@northwestern.edu    
Sub-Investigator: Robert McCarthy, PharmD            
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jeanette Bauchat, M.D. Northwestern University
  More Information

No publications provided

Responsible Party: Jeanette Bauchat, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01597791     History of Changes
Other Study ID Numbers: STU00005516
Study First Received: May 10, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Urinary Retention
Urinary Catheter
Bacteriuria

Additional relevant MeSH terms:
Bacteriuria
Urinary Retention
Urinary Tract Infections
 Infection
Urologic Diseases
Urination Disorders

ClinicalTrials.gov processed this record on May 23, 2013