Rivard 2012.
Methods |
RCT or quasi‐RCT: RCT Setting: USA Period: July 2009 – November 2009 |
|
Participants |
Population: singleton pregnancies in active labour or undergoing induction of labour who were anticipated to have vaginal delivery Inclusion criteria: adult women (age > 18) with a singleton pregnancy who presented to the labour and delivery unit in active labour or for labour induction, were anticipated to have a vaginal delivery, and chose epidural for pain control Exclusion criteria: scheduled for caesarean delivery, had multi‐fetal gestations, required tocolysis, and/or were on magnesium prophylaxis Age (mean): A: 27.6; B: 28.7 Number of participants: · Eligible: 139 · Randomised: 139 · Reported: 138 Dropouts (n of participants + reasons): 1 in intermittent catheter group due to physician withdrawal Follow‐up: duration of labour |
|
Interventions |
Time of intervention: Enrolled participants randomised after physician determined clinical need for catheterisation A (n = 72): indwelling catheter. Removed during 2nd stage of labour when woman started pushing B (n = 67): intermittent catheter inserted every 2 to 4 hours Intended duration of catheterisation: A: until 2nd stage of labour B: unclear |
|
Outcomes |
Primary outcome (symptomatic UTI): not reported Definition of symptomatic UTI: not reported Bacteriuria: not reported Definition of bacteriuria: not reported Cost per catheter: A: USD 6.28; B: USD 5.98 Number of catheterisations (mean, SD not reported, n): A: NR; B: 2.5 Nurses’ perceptions: Preference: A: 30/37; B: 7/37 *Better care: A: 28/37; B: 9/37 **Time requirement: A: 31/37; B: 6/37 Preference for method to be standard care: A: 34/37; B: 2/37 Quality of life: Not reported |
|
Sponsorship/Funding | “No financial disclosures” | |
Notes | *Nurses’ perception of care they provide to patients **i.e. nurses perceived A (indwelling) to be less time‐consuming Not reported if used prophylactic antibiotics |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “computer‐generated list of randomization using permuted block” – adequate method of randomisation |
Allocation concealment (selection bias) | Low risk | “Sequentially numbered opaque envelopes displaying only the randomization number on the outside” – low risk of allocation of intervention being revealed |
Blinding of participants | High risk | No information given on blinding of participants. Can assume that blinding did not occur as indwelling vs intermittent |
Blinding of personnel | High risk | No information given on blinding of personnel. As indwelling vs intermittent can assume blinding did not occur |
Blinding of microbiological outcome assessment | Low risk | Microbiological outcomes not reported, therefore no risk of bias from reporting of microbiological outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 146 enrolled, 7 excluded (2 magnesium prophylaxis, 2 no epidural, 3 delivered prior to randomisation). 139 randomised, 72 indwelling, 67 intermittent 1 withdrawn from intermittent due to physician recommendation. 72 indwelling, 66 intermittent None lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All outcomes were reported in the Results. Unable to access protocol, so uncertainty surrounding selective reporting |
Other bias | Low risk | Appears to be free of other sources of bias |