Cesarean Section ComplicationsNCT06242756
Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
A study testing Bladder catheterization in people with Cesarean Section Complications, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on time to ambulation, time to discharge, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Bladder catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 27 Aug 2024to 18 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS.
Who cannot join
- diagnosis of abnormal placentation including placenta previa, vasa previa, or suspected invasive disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on time to ambulation, time to discharge, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.
Read the detailed description
This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical triage by a trained nurse research assistant. Participants would be randomized into either a catheterized or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured by using either a central computer generator for randomization if funding permits, otherwise sealed, opaque, and sequenced envelopes will be used. Since there may be potential differences in patients with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in treatment groups.
- Conditions
- Cesarean Section Complications
- Being tested
- Bladder catheterization
- Keywords
- cesarean section, bladder catheterization, foley
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder catheterizationProcedure or surgery
Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Bladder catheterization | Experimental | Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section. Receives: Procedure: Bladder catheterization |
| Non-use of bladder catheterization | No intervention | Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ambulation
Time to ambulation will be collected via a form that will be distributed by the postpartum nursing team.
Measured: Prior to discharge, assessed up to 3 days postpartum
Secondary outcomes (6)
Incidence of urinary retention
Urinary retention will be defined based on a patient's inability to spontaneously void requiring either in-and-out catheterization or placement of an indwelling catheter during the post operative course
Measured: Prior to discharge, assessed up to 3 days postpartum
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum
Measured: first 4 weeks postpartum
Incidence of bladder injury in surgery
Incidence of bladder injury in surgery will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.
Measured: During surgery
Operating time
Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.
Measured: During surgery
Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)
Patients will be asked to complete the Maternal Satisfaction for Cesarean Section questionnaire at discharge. The minimum and maximum values are 7 and 154 and higher scores mean a better outcome.
Measured: At discharge, assessed up to 3 days postpartum
Time to discharge
Time to discharge; date and time of discharge will be collected during chart review
Measured: At discharge, assessed up to 3 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start27 Aug 2024
- Primary completion18 Feb 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen L. Wood, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242756
- Sponsor's protocol ID
- REB24-0044
- Status last verified
- Feb 2025
- First submitted
- 19 Jan 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06242756
- Acronym / sponsor ID
- REB24-0044
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean section, bladder catheterization, foley
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on time to ambulation, time to discharge, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.
Detailed description
This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical triage by a trained nurse research assistant. Participants would be randomized into either a catheterized or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured by using either a central computer generator for randomization if funding permits, otherwise sealed, opaque, and sequenced envelopes will be used. Since there may be potential differences in patients with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder catheterization | Experimental | Procedure: Bladder catheterizationPatients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section. |
| Non-use of bladder catheterization | No intervention | –Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS.
Key exclusion criteria (1 listed)
- diagnosis of abnormal placentation including placenta previa, vasa previa, or suspected invasive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder catheterizationPatients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post cesarean section. | Procedure or surgery | Bladder catheterization |
Primary outcome
Time to ambulation
Time frame: Prior to discharge, assessed up to 3 days postpartum
Time to ambulation will be collected via a form that will be distributed by the postpartum nursing team.
6 secondary outcomes
Incidence of urinary retention
Time frame: Prior to discharge, assessed up to 3 days postpartum
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum
Time frame: first 4 weeks postpartum
Incidence of bladder injury in surgery
Time frame: During surgery
Operating time
Time frame: During surgery
Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)
Time frame: At discharge, assessed up to 3 days postpartum
Time to discharge
Time frame: At discharge, assessed up to 3 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen L. Wood, MD, MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder catheterization in people with Cesarean Section Complications, run by University of Calgary at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Sep 2026. 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 Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to ambulation (time frame: Prior to discharge, assessed up to 3 days postpartum). 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 18 Sep 2026.