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

El‐Mazny 2014.

Study characteristics
Methods Study design: RCT
Dates study conducted: November 2012‐March 2014
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
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
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)
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