Aref 2020.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: September 2016–April 2018 |
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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 |
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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) |
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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 |
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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.” |
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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 |