Azarkish 2005.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: May 2001‐September 2001 |
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| Participants |
Population: women Setting: Mashahd, Iran Inclusion criteria: emergency CS, age 18‐35 years old, pregnancy 1‐4, pregnancy period 37‐42 weeks, no UTIs Exclusion criteria: diabetic mothers, women with fever and trembling 24 h before surgery Condition for hospitalisation: emergency CS Number of participants: 333 eligible; 60 randomised; 56 reported Age (mean and SD): not reported Use of antibiotic prophylaxis: perineum wash by povidone iodine 10% before catheter insertion |
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| Interventions |
Group A (n = 30): IUC removal 2‐3 h post‐op Group B (n = 30): IUC removal 24 h post‐op Size and type of catheter used: size 14 Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: IUC removal 2‐3 h post‐op Group B: IUC removal 24 h post‐op |
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| Outcomes | Average pain severity of IUC insertion on pain VAS (mean ± SD) Average pain severity of IUC removal on pain VAS (mean ± SD) |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | Dr. Fazli Bazzaz (Research vice chancellor at Mashad Medical University) | |
| Ethical approval | Not reported | |
| Notes | Paper written in Farsi. Translation provided by a translator | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from translator: “2 groups, 30 persons each, randomised totally by chance” Comment: unclear method of randomisation |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely possible given nature of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | No microbiological outcomes reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote from translator: “number of participants is 56 person, but there is no explanation for that in the paper” Comment: translator could not identify reason for missing pain data for four participants in the pain on removal of catheter group |
| Selective reporting (reporting bias) | High risk | No baseline data reported despite authors mentioning data was collected |
| Other bias | Low risk | Appears to be free from other sources of bias |