Methods | RCT with block randomization. | |
Participants | 90 pregnant women attending the Department of Urology and antenatal clinics of the Obstetrics and Gynecology Department of Fatih University between the period of November 2004-May 2005 Women with no signs and symptoms of urinary tract infections, in the second trimester who screened positive for asymptomatic bacteriuria (defined as the presence of 2 consecutive clean-catch urine specimens yielding positive cultures (100,000 cfu/ml) of the same uropathogens in a patient without urinary symptoms) Women exhibiting leukocytosis, fever, urolithiasis, lower back pain, or with a history of previous urologic surgery and known abnormalities of the urinary tract were excluded from the study. 1100 pregnant women in the second trimester were screened, of which, 90 gravidas had at least 1 bacteria identified in 2 consecutive voided urine specimens The randomized groups were similar in terms of mean patient age and mean gestational age of pregnancy. E. coli was the most common initial isolated microorganism in the pretreated urine specimen. 93.2% of pathogens in the fosfomycin trometamol group and 95% in the cefuroxime axetyl group were E. coli (the difference is NS). Other enterobacteriaceae and some gram-positive cocci were also isolated in both groups. The proportion of isolated microorganisms did not differ statistically between the groups |
|
Interventions | Group I: 45 women (mean age 25.4 ± 4.7 years and mean duration of pregnancy 16.0 ± 2.0 weeks (range 14-18 weeks)) received a single dose of 3 g fosfomycin trometamol Group II: 45 women (mean age 25.2 ± 4.7 years and mean duration of pregnancy 16.2 ± 2.4 weeks (range 14-20 weeks)) received 250 mg cefuroxime axetyl twice a day for 5 days |
|
Outcomes | Primary outcomes: Symptomatic infection: not reported. Persistent infection: group 1: 3/44 (6.8%); group 2: 2/40 (5%) (P = 0.912). Recurrent infection: not reported. Shift to another antibiotic: not reported. Adverse effects: both regimens well-tolerated. Allergic skin rash: group 1: 1/44 (2.27%); vulvovaginal moniliasis: group 2: 2/40 (5%) Secondary outcomes: Preterm delivery: not reported. Preterm labor: not reported. Neonatal infection: not reported. RDS in the neonate: not reported. Admission to NICU: not reported. Duration of neonatal respiratory support: not reported. |
|
Notes | Control cultures were mentioned in the results. But subjects were only randomized into 2 treatment groups at the start of the study (each group received either fosfomycin trometamol or cefuroxime axetyl) | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Blocks were numbered. It was not stated whether the numbers came from a table of random numbers (p. 526) |
Allocation concealment? | Yes | To ensure an equal number of patients in each group, a block randomization method was used. The blocks were numbered, placed into a bag, and a staff member blinded to the research protocol selected the patients into the treatment groups. (p. 526) |
Blinding? Participant |
No | One treatment intervention was given single dose, the other was given as multiple doses |
Blinding? Clinician |
No | Same as above. |
Blinding? Outcome assessor |
Unclear | It was not mentioned. |
Incomplete outcome data addressed? All outcomes |
No | One woman in the fosfomycin trometamol group and 5 women in the cefuroxime axetyl group did not come to the scheduled follow-up visit by their physician and for a repeat urine analysis and urine culture 1 week after; therefore, they were excluded from the study. The remaining were 44 patients in the fosfomycin trometamol group and 40 patients in the cefuroxime axetyl group (dropout rate 2.2 and 11.1%, respectively). There was no intention-to-treat analysis. |
Free of selective reporting? | Yes | All of the outcomes they planned to assess in the study were reported |
Free of other bias? | Yes |