Clinical trial NCT06881849: Duration of Urinary Catheterization Following Cesarean Deliveries Under Neuraxial Anesthesia
Official title: Duration of Urinary Catheterization Following Cesarean Deliveries Under Neuraxial Anesthesia: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cesarean Delivery
Urinary Catheterization
Keywords: patient recovery
cesarean delivery
urinary catheterization
foley catheter
patient anxiety
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's who underwent a cesarean delivery at BC Women's Hospital.

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.

Detailed description: This study aims to analyze how long foley catheters stay in the patient after their cesarean delivery under neuraxial anesthesia and what barriers there are in taking them out earlier.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Correlation between duration of urinary catheterization and STAI-S score
timeFrame: From the time of enrollment until urinary catheter removal, assessed up to 24 (+/- 8) postpartum.
Secondary outcomes:
measure: Timing of delivery
timeFrame: 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)
measure: Neuraxial Technique
timeFrame: From urinary catheter placement until its removal, assessed up 24 (+/- 8) hours postpartum, categorized by neuraxial technique used during delivery
measure: Opioid Dose
timeFrame: From urinary catheter placement until its removal, assessed up to 24 (+/- 8) hours postpartum, categorized by total neuraxial opioid dose administered.
measure: Nursing Perception
timeFrame: Survey completed by the patient's postpartum nurse within 24 (+/- 8) hours after urinary catheter removal.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Anton Chau, MD MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.