NCT06881849

Brief Summary

In cesarean deliveries, urinary catheters are often used to help empty the bladder while patients have limited mobility. These catheters typically stay in during early recovery because certain pain medications can make it hard for patients to urinate. Recently, the Society of Obstetric Anesthesia and Perinatology (SOAP) recommended removing catheters within 6-12 hours after delivery to aid recovery. However, at BC Women's Hospital, a review found that catheters stayed in for an average of 19 to 19.4 hours, even when patients were mobile. Leaving catheters in too long can increase the risk of urinary tract infections (UTIs), pain, and urination issues, which can delay recovery and extend hospital stays. An internal review showed that factors like patient anxiety may affect when catheters are removed. Postpartum anxiety affects around 9.9% to 20.7% of new mothers in the first year and is an important factor in recovery after a cesarean delivery. The main goal of this study is to look at how long urinary catheters stay in patients who had a cesarean delivery under spinal or epidural anesthesia, and what the score is from a questionnaire used to measure anxiety called the State Trait Anxiety Inventory (STAI-S), to see if there is a link between them.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

February 13, 2025

Last Update Submit

March 11, 2025

Conditions

Keywords

patient recoverycesarean deliveryurinary catheterizationfoley catheterpatient anxiety

Outcome Measures

Primary Outcomes (1)

  • Correlation between duration of urinary catheterization and STAI-S score

    The STAI-S scale measures the respondents current state of anxiety by using terms to evaluate subjective feelings of worry, apprehension, concern, and nervousness. The scoring is 20-37 to indicate low anxiety, 38-44 to indicate moderate anxiety, and 45-80 to indicate high anxiety.

    From the time of enrollment until urinary catheter removal, assessed up to 24 (+/- 8) postpartum.

Secondary Outcomes (4)

  • Timing of delivery

    From urinary catheter placement until its removal, assessed up to 24 (+/- 8) hours postpartum, categorized based on delivery time (e.g., morning: 06:00-11:59, afternoon: 12:00-17:59, evening/night: 18:00-05:59)

  • Neuraxial Technique

    From urinary catheter placement until its removal, assessed up 24 (+/- 8) hours postpartum, categorized by neuraxial technique used during delivery

  • Opioid Dose

    From urinary catheter placement until its removal, assessed up to 24 (+/- 8) hours postpartum, categorized by total neuraxial opioid dose administered.

  • Nursing Perception

    Survey completed by the patient's postpartum nurse within 24 (+/- 8) hours after urinary catheter removal.

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient's who underwent a cesarean delivery at BC Women's Hospital.

You may qualify if:

  • Patients ≥19 years of age.
  • Undergoing cesarean delivery (elective or emergent) at BC Women's Hospital.
  • Neuraxial anesthesia as their primary mode of anesthesia (spinal, epidural, combined spinal-epidural, dural-puncture epidural).
  • In-patient status at 24 (+/- 8) hours.
  • Self-reported proficiency in speaking and reading English.

You may not qualify if:

  • Refusal to participate.
  • Inability to provide informed consent.
  • Other surgery (i.e. cervical cerclage) or delivery modes (i.e. operative vaginal delivery).
  • De novo general anesthetic, or patients who had a conversion from neuraxial to a general anesthetic.
  • Communication from patient's nurse indicating that it is not appropriate to approach due to distressing birth experience and/or outcome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (6)

  • Figueiredo B, Conde A. Anxiety and depression in women and men from early pregnancy to 3-months postpartum. Arch Womens Ment Health. 2011 Jun;14(3):247-55. doi: 10.1007/s00737-011-0217-3. Epub 2011 Apr 9.

    PMID: 21479759BACKGROUND
  • Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.

    PMID: 22588767BACKGROUND
  • Goodman JH, Watson GR, Stubbs B. Anxiety disorders in postpartum women: A systematic review and meta-analysis. J Affect Disord. 2016 Oct;203:292-331. doi: 10.1016/j.jad.2016.05.033. Epub 2016 Jun 1.

    PMID: 27317922BACKGROUND
  • Sutherland E, Yang T, Chau A. Duration of Urinary Catheterization After Cesarean Deliveries: A Retrospective Cohort Study..Poster session presented at: 2023 Summer Student Poster Day; 2023 Jul 27; Chieng Family Atrium, BC Children's Research Institute

    BACKGROUND
  • Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.

    PMID: 33177330BACKGROUND
  • Basbug A, Yuksel A, Ellibes Kaya A. Early versus delayed removal of indwelling catheters in patients after elective cesarean section: a prospective randomized trial. J Matern Fetal Neonatal Med. 2020 Jan;33(1):68-72. doi: 10.1080/14767058.2018.1487394. Epub 2018 Jul 18.

    PMID: 29886771BACKGROUND

Study Officials

  • Anton Chau, MD MMSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aislynn L. Sharrock, BA (Hons)

CONTACT

Juliana Barrera, MD MSc FRCPC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

February 13, 2025

First Posted

March 18, 2025

Study Start

April 25, 2025

Primary Completion

July 30, 2025

Study Completion

December 1, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations