El‐Mazny 2014.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: November 2012‐March 2014 |
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Participants |
Number of participants: 335 eligible; 300 randomised; 300 reported Setting: Cairo Country: Egypt Population: women Age (mean and SD): Group A: 24.5 ± 4.2; Group B: 23.8 ± 3.9 Inclusion criteria: women admitted to the prenatal wards for primary or repeat elective CS were screened to determine eligibility for inclusion. Condition for hospitalisation: primary or elective CS Exclusion criteria: urinary infection (assessed clinically and by midstream urinalysis); significant vaginal bleeding; severe pre‐eclampsia or eclampsia; and/or any other conditions requiring post‐operative monitoring of urinary output; contraindications for general anaesthesia Use of antibiotic prophylaxis: cefazolin 2 g IV single dose 30 min before surgery |
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Interventions |
Group A (n = 150): IUC removed immediately after the procedure Group B (n = 150): IUC removed 12 h post‐operatively Size and type of catheter used: 16F Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: IUC removed immediately post‐op Group B: IUC removed 12 h post‐op |
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Outcomes | Significant bacteriuria Urinary retention Dysuria Urinary frequency Urgency Time to post‐op ambulation (h) Time to first void post‐op (h) Hospital stay (h) |
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Definition of CAUTI or bacteriuria | Significant bacteriuria = > 105 bacteria per mL urine in a midstream sample collected 24 h post‐operatively | |
Sponsorship/funding | Not reported | |
Ethical approval | The study protocol was approved by the Scientific Research Committee, and informed consent was obtained from all participants. | |
Notes | If patient still had difficulty in passing urine after 6 h and/or if abdominal examination showed palpable urinary bladder, recatheterisation was done | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “A total of 300 women were allocated into two groups in a 1:1 ratio by block randomisation using computer‐generated random numbers.” Comment: adequate method of randomisation |
Allocation concealment (selection bias) | High risk | Not reported. Unlikely that allocation concealment was performed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely blinding was possible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Blinding of microbiological outcome (detection bias) | Low risk | Not reported. It is likely that urine samples were sent to a laboratory where the microbiologist would be unlikely to know if patients were in a trial or not |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals reported |
Selective reporting (reporting bias) | Low risk | All outcomes are reported in both the methods and results section and are fully accounted for |
Other bias | Low risk | Nothing to indicate any other source of bias |