Bayrak 2007.
Methods | Randomized controlled trial. 90 pregnant women were randomized to receive either a single dose fosfomycin trometamol or a 5‐day course of cefuroxime axetyl. Pregnant women were not blinded to treatment assignment. It was unclear whether the following criteria were met: measurement of contamination of control group, assessments of co‐interventions. Power calculation described, sample size calculation conducted. | |
Participants | 90 women were enrolled in the trial. Setting: women attending the department of Urology and ANC clinics of Faith University, Ankora, Turkey. 1 patient in the fosfomycin trometamol group and 5 patients in the cefuroxime axetyl group were lost to follow‐up and excluded from the trial. Inclusion criteria: pregnant women in the second trimester of gestation, confirmed asymptomatic bacteriuria with 2 consecutive clean‐catch urine specimens yielding positive cultures of the same uropathogen. Exclusion criteria: gravidas presenting leukocytosis, fever, urolithiasis, lower back pain, previous urologic surgery, anomalies of the urinary tract. | |
Interventions | Experimental group: single dose of 3 g fosfomycin trometamol. Control group: cefuroxime axetyl 250 mg twice a day for 5 days. |
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Outcomes | Clinical outcome: side effects. Laboratory outcome: bacteriological eradication of uropathogens. |
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Notes | Cure rates are informed only as percentages. No ratios are informed. Side effects are informed in percentages. No risk ratios nor confidence intervals provided. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A block randomization method was used to ensure an equal number of patients in each group. |
Allocation concealment (selection bias) | Low risk | The blocks were numbered, placed into a bag, and a staff member blinded to the research protocol selected the patients into the treatment groups. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 patient in the fosfomycin trometamol group and 5 patients in the cefuroxime axetyl group did not come to the follow‐up visit; therefore, they were excluded from the study. |
Selective reporting (reporting bias) | Unclear risk | Not mentioned. |
Other bias | Low risk | Sample size and power calculation provided. No other risk noted. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The staff members were blinded. |