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

Aref 2020.

Study characteristics
Methods Study design: RCT
Dates study conducted: September 2016–April 2018
Participants Population: women
Setting: Taif, Saudi Arabia
Inclusion criteria: pregnant women with term singleton pregnancy prepared for term elective CS either primary or repeated
Condition for hospitalisation: elective CS
Exclusion criteria: women who had UTIs pre‐operatively, confirmed by urine analysis ± culture and sensitivity, women with iatrogenic bladder injury so that IUC had to be kept post‐operatively on the surgeon’s decision, women with severe pre‐eclampsia or eclampsia and/or any other conditions requiring post‐operative monitoring of urinary output, and women who had spinal anaesthesia by choice or contraindicated for general anaesthesia
Number of participants: 238 eligible; 221 randomised; 221 reported
Age (mean and SD): A 26.1 ± 4, B 25.3 ± 2, C 25.6 ± 3
Use of antibiotic prophylaxis: all participants received a single dose of prophylactic antibiotic in the form of ceftriaxone 1 g IM
Interventions Group A (n = 73): IUC removal immediately after surgery
Group B (n= 81): IUC removal 6 h post‐op
Group C (n = 67): IUC removal 24 h after operation
Size and type of catheter used: size 12 silicone, 2‐way Foley’s catheter
Study definition of short‐term catheterisation (days): up to 24 h
Intended duration of catheterisation for each group:
Group A: immediate removal after surgery (n = 73)
Group B: removal 6 h post‐op (n = 81)
Group C: removal 24 h post‐op (n = 67)
Outcomes Number of participants requiring recatheterisation
Symptomatic UTI (number of participants)
Time to first ambulation (h; mean ± SD)
Length of hospital stay (days; mean ± SD)
Positive urine culture
Fever
Dysuria
Definition of CAUTI or bacteriuria “The diagnosis of symptomatic UTI was based on the following criteria: significant bacteriuria with at least one of the following symptoms; dysuria, frequency of micturition, urgency, supra pubic pain, or burning sensation at micturition.”
Sponsorship/funding Not reported
Ethical approval “This study was carried out in accordance with the ethical principles for medical research involving human subjects included in Helsinki declaration and was approved by Ethical Committee.”
Notes “Urinary retention defined as: inability for spontaneous micturition within
6 h after the removal of urinary catheter”
“Seventeen patients were finally excluded from the study; five patients had intraoperative complications (iatrogenic bladder injury) and therefore an indwelling catheter had to be kept postoperatively on the surgeon’s request while 12 did not complete the postoperative follow‐up.”
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “were divided into three groups by simple randomization using computer‐generated random numbers.”
Comment: adequate randomisation method
Allocation concealment (selection bias) Unclear risk Not reported.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported. Unlikely given nature of intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported. Unlikely outcomes are affected by non‐blinding however.
Blinding of microbiological outcome (detection bias) Low risk Not reported. Assume microbiologist was blinded to participants of the study
Incomplete outcome data (attrition bias)
All outcomes Low risk No incomplete outcome data
Selective reporting (reporting bias) Low risk Appears to be free form reporting bias
Other bias Low risk Appears to be free from other sources of bias