Basbug 2020.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: December 2015‐December 2016 |
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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” |
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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 |
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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) |
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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 |
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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 |