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. 2021 Jun 29;2021(6):CD004011. doi: 10.1002/14651858.CD004011.pub4

Basbug 2020.

Study characteristics
Methods Study design: RCT
Dates study conducted: December 2015‐December 2016
Participants Population: women
Setting: Duzce, Turkey
Inclusion criteria: women who were accepted for primary or recurrent elective CS
Condition for hospitalisation: elective CS
Exclusion criteria: patients with UTI (evaluated by urine examination), severe vaginal bleeding, severe pre‐eclampsia, eclampsia, and any other conditions requiring post‐operative monitoring of urinary output were excluded from the trial.
Number of participants: 172 eligible; 136 randomised; 136 reported
Age (mean and SD): A 30.13 ± 5.83; B 29.96 ± 4.71
Use of antibiotic prophylaxis: “All patients received 1 g IV cefazolin as prophylaxis”
Interventions Group A (n = 62): IUC removal 2 h after procedure
Group B (n = 72): IUC removal 12 h after procedure
Size and type of catheter used: French size 16 silicone‐covered latex Foley catheters
Study definition of short‐term catheterisation (days): not reported
Intended duration of catheterisation for each group:
Group A: 2 h
Group B: 12 h
Outcomes Number of participants requiring recatheterisation
Dysuria
Asyptomatic bacteriuria
Urinary frequency
Urgency
Length of hospitalisation stay (h)
Fever
Time to first void (h; mean ± SD)
Definition of CAUTI or bacteriuria Significant microscopic bacteriuria was defined as ≥ 100,000‐bacteria/mL urine in a midstream sample
Sponsorship/funding Not reported
Ethical approval The study was approved by the Ethics Committee of the Duzce Medical Faculty (IRB No. 000021705, Approval No. 2015/174)
Notes Recatheterisation was performed if spontaneous micturition was not possible or urinary retention was detected in the suprapubic region by either abdominal examination or measurement of post‐voiding residual (PVR) volume by ultrasound
The definition of urinary retention was, lack of spontaneous micturition 6 h after the removal of catheter or PVR volume > 200 mL measured by transabdominal ultrasound
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Patients were randomly allocated by a computer program in a 1:1 ratio to the early or delayed catheter removal groups”
Comment: adequate randomisation method
Allocation concealment (selection bias) Unclear risk Quote: “Patients were randomly allocated by a computer program in a 1:1 ratio to the early or delayed catheter removal groups.”
Comment: not reported
Blinding of participants and personnel (performance bias)
All outcomes High risk Likely blinding not possible for this outcome
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported
Blinding of microbiological outcome (detection bias) Low risk Not reported. Assume urine samples were sent to a laboratory where the microbiologist would not know which patients were in the trial
Incomplete outcome data (attrition bias)
All outcomes Low risk ‘As‐treated’ analysis carried out. 4/68 participants in 1 group were analysed in the other group but unlikely to have substantial impact
Selective reporting (reporting bias) Low risk Outcomes seem to be reported in full
Other bias Low risk Appears to be free from other sources of bias