Zhou 2012.
Study characteristics | ||
Methods |
Study design: quasi‐RCT Dates study conducted: January‐December 2011 |
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Participants |
Population: women undergoing CS for: cephalopelvic disproportionate; social reasons; stuck fetus; abnormal placenta; twins; overly large baby; scarred uterus; other reasons unstated Setting: Guangdong Hospital Inclusion criteria: obstetric patients undergoing CS Exclusion criteria: heart, liver, kidney, brain or other severe conditions, no obstetric complications or conditions Surgical or anaesthesia complications Condition for hospitalisation: CS Number of participants: eligible, not reported; 138 randomised; 138 reported Age (mean and SD): Group A: mean 25.11, SD 4.88, rRange 20‐33 Group B: mean 26.33, SD 5.08, range 19‐35 Use of antibiotic prophylaxis: not reported |
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Interventions |
Size and type of catheter used (e.g. Foley 16F): not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: removal of IUC at 6 h post surgery (intervention) (n = 46) Group B: removal of IUC at 8 h post surgery (intervention) (n = 46) Group C: removal at 24 h (control) (n = 46) |
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Outcomes | Urinary retention Post‐op 24 h bleeding Post‐op comfort after removal (measuring using VAS and urinary symptoms. “Mild” – pain score 1‐3, “Moderate” 4‐7, “Severe” 8‐10) |
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Definition of CAUTI or bacteriuria | Defined as post‐catheter removal midstream clean catch culture of ≥ 104 cfu/mL for Gram‐positive organisms or ≥ 105 cfu/mL for Gram‐negative organisms | |
Sponsorship/funding | Not reported | |
Ethical approval | Not reported | |
Notes | Translator note: there is no description given of how the intervention group is separated into 6‐ or 8‐hour removal | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Patients were allocated based on timing of presentation (odd or even days) into either intervention (6 h or 8 h removal) or control (24 h) |
Allocation concealment (selection bias) | High risk | Patients were allocated based on timing of presentation (odd or even days) into either intervention (6 h or 8 h removal) or control (24 h) |
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 | Not reported, likely that specimens sent to a lab |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All completed, none lost |
Selective reporting (reporting bias) | Low risk | Appears free from selective bias |
Other bias | Low risk | Nothing to indicate any other source of bias |