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. 2015 Nov 11;2015(11):CD000491. doi: 10.1002/14651858.CD000491.pub3

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.
Outcomes Clinical outcome: side effects.
Laboratory outcome: bacteriological eradication of uropathogens.
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.
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.