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AnesthesiaNCT01597791

Combined Spinal Epidural Urinary Retention

A study testing Foley catheter and No foley catheter in people with Anesthesia and Pain, run by Northwestern University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Anesthesia, Pain, Urinary Retention
What is being tested?
Foley catheter and No foley catheter
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteUnited States
Study dates
22 Mar 2012to 1 Dec 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

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?

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.

Read the detailed description

Participation in the study will begin at the patient's request for labor analgesia. The patient will be asked to urinate and a post void residual (PVR) will be measured via ultrasonography. If the PVR is >100mL, the patient will be excluded from the study. If CSF is not obtained during CSE placement or the CSE technique is abandoned for any other reason, the patient will be excluded. If the PVR is < 100mL and the combined spinal epidural analgesia is successful, they will be randomized to receive either routine Foley catheter placement or begin the spontaneous micturition protocol. Last cervical exam and VRS pain will be recorded at this time.

Subjects will be prepared in the usual fashion for the combined spinal epidural with hemodynamic monitoring and intravenous (IV) access.

The anesthesiologist will perform a combined spinal epidural analgesia per routine with the subject in the sitting position using sterile technique at the L3-4 interspace (± one vertebral interspace). The epidural space will be found using loss of resistance technique with either 3 mL of air or saline and a 17G Touhy needle. After the epidural space is identified, the dura will be punctured with a 27G Pencan and 2.5mg of plain bupivacaine + 15 μg fentanyl will be injected. The epidural catheter will be inserted to 3-5cm into the epidural space and a test dose of 3 mL of 1.5% lidocaine + 1:200,000 epinephrine will be injected. The epidural catheter will be secured and the PCEA initiated with the standard infusion rate and patient administered boluses using 0.06% bupivacaine + 2mcg/mL fentanyl. Post-procedure vital signs will be monitored in the usual fashion.

Patients randomized to the control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution. Their bladder volume will be assessed via ultrasonography before Foley catheter placement. The volume of urine collected in the Foley bag will be used to validate our ultrasonographic measurements.

Patients randomized to the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals. First, the patient's bladder volume is measured via ultrasonography; this is followed by an attempt at spontaneous micturition. The patient will have an attempt at spontaneous micturition only if their bladder contains >100mL of urine. This ensures inability to micturate is not due to insufficient urine in the bladder prior to their attempt. An ultrasonographic measurement of their postvoid residual volume will follow their attempt to spontaneously micturate, to ensure the patient does not have urinary retention necessitating Foley catheter placement.

The first attempt at spontaneous micturition is two hours after the spinal analgesic dose is injected. A study by Campbell et al. demonstrated no urinary retention with this intrathecal dose, but it is a possibility that the spinal dose may still be present and have a differing effect than the epidural analgesic dose. As a result of this possibility, we decided that if a patient has urinary retention at this first attempt, 2 hours post injection of the spinal dose, they will have a straight catheterization and be given another chance at spontaneous micturition more than 3 hours after the spinal dose was injected. This ensures the spinal dose has completely worn off and the epidural analgesic dose is in effect before committing the patient to a bed pan or Foley catheter.

Most patients will be evaluated at least twice for ability to spontaneously micturate and have their PVR volumes accessed via ultrasonography before being assigned to either a bed pan every 2 hours or a Foley catheter placement. If the patient is able to spontaneously micturate twice and their PVR is <100mL, they will be assigned to a bed pan every 2 hours. If a patient is unable to micturate with a PVR >100mL, they will receive a Foley catheter.

The spontaneous micturition algorithm allows for a maximum of 3 attempts at micturition before a patient is committed to either a bed pan every 2 hours or Foley catheter placement. In the event that a patient is able to spontaneously micturate but has incomplete bladder emptying with a PVR 100-250mL, they will be allowed to continue in the algorithm for a third and final attempt at spontaneous micturition. If the patient is able to spontaneously micturate at this last attempt with a PVR volume <100mL, they will be assigned to a bed pan every 2 hours but if their PVR remains >100mL they will have a Foley catheter placed.

On occasion, patients need a rescue bolus of higher concentration local anesthetic during labor for breakthrough pain. If this occurs, the usual rebolus dose of up to 15mL of bupivacaine 0.125% will be given in incremental doses titrated to patient comfort. Following this rebolus, the infusion rate will be increased to 20ml/hr as is the usual practice. If a patient who was previously assigned to use a bed pan every 2 hours requires a rescue bolus of local anesthetic, their ability to spontaneously micturate will be reassessed 2 hours following the rebolus to evaluate for need for reassignment to Foley catheter placement with the higher doses of bupivacaine.

If a patient who was assigned to use a bed pan every 2 hours requires a second rebolus, they will receive another rebolus dose of up to 15mL of bupivacaine 0.125%, the concentration of the epidural bupivacaine infusion will be increased to bupivacaine 0.11% + fentanyl 2mcg/mL as is our usual practice and they will automatically be assigned to a Foley catheter placement.

If a study patient requires a cesarean delivery, a Foley catheter will be inserted at time of decision for cesarean delivery and removed 24 hours post procedure as is the standard practice at our institution.

The primary outcome (rate of positive urine culture) of 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 postpartum is unknown. If the patient is considered uncomplicated (normal female urinary physiology) then she would be treated only if she has symptoms. If the patient is considered complicated (pregnant urinary physiology) then she would be treated for bacterial growth on urine culture even if asymptomatic. For this reason and for the purpose of this study, if the patient is asymptomatic for urinary tract infection but has a positive urine culture with 50,000 colony-forming units (CFU)/mL of bacteria, the patient's obstetrician will be notified and they will likely be treated with antibiotics for suspected urinary tract infection. This is more conservative than the current guidelines for asymptomatic bacteriuria in pregnancy. If a positive urine culture is identified and patients is symptomatic (at least1 sign/symptom) with the number of colonies of bacteria exceed 10,000 CFU/ml, the obstetrician will be notified and they may be treated with antibiotics for suspected urinary tract infection. This is more conservative than the guidelines for catheter-related infections.

In addition to the primary outcome data, the following information will be collected after delivery: satisfaction with bladder treatment protocol (100 mm scale, 0 mm = not satisfied at all, 100 mm = very satisfied), total labor duration, length of stage 2, mode of delivery, presence and degree of lacerations, fetal weight, duration of Foley catheterization, time to first spontaneous void following delivery or Foley catheter removal, total fluids administered during labor and total dose of epidural analgesics.

In addition, a postvoid residual (PVR) will be assess via ultrasound at 8-24 hours following delivery or foley catheter removal to assess for postpartum urinary retention. If the PVR is found to be >100mL postpartum, this will be considered urinary retention and the obstetrician and co-investigator (urogynecologist) will be notified.

The following demographic data will also be collected: maternal age, height, weight, pre-pregnancy weight, and gestational age.

One telephone follow-up evaluation 8 weeks after delivery, the patient will be assessed for treatment of urinary tract infection and urinary retention during or after discharge from the hospital.

Being tested
Foley catheter, No foley catheter
Keywords
Urinary Retention, Urinary Catheter, Bacteriuria
Medical subject headings
Pain, Urinary Retention, Bacteriuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foley catheterDevice

    Foley catheter placement after CSE.

  • No foley catheterOther

    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.

Study groups in NCT01597791
Study groupRoleWhat they receive
Foley catheterPlacebo comparatorControl group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.
Receives: Device: Foley catheter
No Foley CatheterExperimentalSpontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.
Receives: Other: No foley catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Positive Urine Culture

    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.

    Measured: 48 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2012 (estimated)
  2. Study start22 Mar 2012
  3. Primary completion1 Dec 2016
  4. Study completion1 Dec 2016

Why it stopped: Change in procedure.US technically challenging.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01597791
Sponsor's protocol ID
STU00005516
Status last verified
Sep 2018
First submitted
10 May 2012
Last updated
5 Oct 2018
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Foley catheter and No foley catheter in people with Anesthesia and Pain, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Positive Urine Culture (time frame: 48 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.

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