Wren 1969.
Methods | 2 parallel groups. Quasi‐RCT | |
Participants | Inclusion: bacteriuria (midstream urine) x 2 at initial antenatal visits; microbiological criteria not stated Setting: University Hospital, New South Wales, Australia Number of participants: N = 183 |
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Interventions | Nitrofurantoin 100 mg twice a day x 2 weeks, then ampicillin 250 mg every 6 hours x 1 week, then sulphurazole 500 mg every 6 hours x 4 weeks, then nalidixic acid 500 mg every 6 hours x 2 weeks; repeat until 1 to 6 weeks after delivery (N = 83), or no treatment (N = 90) | |
Outcomes | Preterm birth (< 37 weeks) or low birthweight (< 2500 g) | |
Notes | There were no stillbirths or neonatal deaths in the treated group; 6 in the no treatment group Dates of study: November 1965 to December 1968 Funding sources: Smith Kline and French Laboratories, Beecham Laboratoies, Roche Products, Winthrop Laboratories Declarations of interest: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Women "were divided into two groups, alternate patients being treated". |
Allocation concealment (selection bias) | High risk | Women "were divided into two groups, alternate patients being treated". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding; knowledge of treatment group may have influenced outcome; women in untreated group who developed clinical urinary tract infection (33/90) were given antibiotics at the choice of the obstetrician, continued to delivery in over 50% of cases. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding; however, outcome of birthweight unlikely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 10 women not included in outcomes: 2 sets of twins excluded, 6 women moved and only 2 could be traced, 3 women delivered before antibiotics could be started, 1 woman refused treatment |
Selective reporting (reporting bias) | High risk | Outcome of pyelonephritis not reported |
Other bias | Low risk | The study appears to be free of other sources of bias. |
Overall Risk of Bias | High risk | Judged as high risk of bias |
Please attend closely to the study period for patient enrolment (found under 'Method'); in several instances there were significant delays between the enrolment period and the published report.
ASB: asymptomatic bacteriuria BP: blood pressure CFU: colony forming units G6PD: glucose‐6‐phosphate‐dehydrogenase IU: international unit RCT: randomised controlled trial SD: standard deviation SE standard error vs: versus