Naguimbing‐Cuaresma 2007.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: April 2004‐April 2005 |
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| Participants |
Population: women Setting: Manila Country: Phillipines Inclusion criteria: women admitted for an elective repeat CS and those who underwent emergency CS for the following indications: malpresentation, multiple gestation, cord accidents, placenta praevia totalis, non‐reassuring fetal status, and previous CS in labour Condition for hospitalisation: CS Exclusion criteria: pregnant patients with concomitant hypertensive diseases, cardiovascular diseases, preeclampsia, eclampsia, gestational diabetes mellitus, bronchial asthma, thyroid disorders, connective tissue diseases and malignancy Number of participants: 240 eligible; 240 randomised; 240 reported Age (mean and SD): not reported Use of antibiotic prophylaxis: not reported |
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| Interventions |
Group A (n = 120): IUC removal 4 h post‐op Group B (n = 120): IUC removal 24 h post‐op Size and type of catheter used: not reported Study definition of short‐term catheterisation (days): 24 h Intended duration of catheterisation for each group: Group A: 4 h post‐op Group B: 24 h post‐op |
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| Outcomes | Time to first void Urinary discomfort Time to first ambulate Length of hospital stay Number of participants requiring recatheterisation |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | Not reported | |
| Ethical approval | Not reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Subjects were randomly assigned using a table of random numbers into two groups” Comment: adequate randomisation method |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “The surgeons were blinded prior to the operation as to where the patient would be included and would only be informed immediately after the cesarean section to give the post‐operative order for urinary catheter removal” Comment: unlikely this was possible given intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “Interview was done on day 1 post operation by a medical personnel blinded from the study and information as to the time of first void, level of discomfort, time of first ambulation were obtained from each subject” Comment: outcome assessor blinded |
| Blinding of microbiological outcome (detection bias) | Low risk | No microbiological outcomes reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts or withdrawals |
| Selective reporting (reporting bias) | High risk | No baseline data reported. No data reported for discomfort measured by VAS |
| Other bias | Low risk | Appears to be free from other sources of bias |