Primary results of a prospective comparative non-interventional study for the treatment of asymptomatic bacteriuria in pregnant women
Authors:   Belgorod National Research University, Belgorod, Russia, Shkodkin S.V. , Fliginskikh N.A. ,   Antenatal clinic No.7, Belgorod, Russia, Zhdanovskaya N.V. ,   Antenatal clinic No.7, Belgorod, Russia, Li L.F. ,   Antenatal clinic No.7, Belgorod, Russia, Yustitskaya E.Yu. ,   Antenatal clinic No.8, Belgorod, Russia, Esina M.M. ,   Antenatal clinic No.8, Belgorod, Russia, Fedorenko S.V. ,   Antenatal clinic No.1, Belgorod, Russia
Published: April 2021

Introduction. Over the past three decades, the views on the diagnosis and treatment of asymptomatic bacteriuria in pregnant women have not undergone any changes. However, the majority of randomized clinical trials concerning the treatment of pathients with this nosology are of low methodological quality and date back to the 60-80s. Since then, diagnostic and treatment protocols have changed dramatically, so the quality of the evidence base is low. In a recent Scandinavian study of higher methodological quality, there was no clear benefit of antibiotic therapy in pregnant women with asymptomatic bacteriuria. Material and methods. This publication is devoted to the interim results of a study that analyzed the efficacy and safety of herbal medicinal product Canephron® N in the treatment of asymptomatic bacteriuria in 29 pregnant women aged 22 to 34 years at a gestation period of 14-28 weeks. When included in the study, as well as on days 14, 30 and 60, the following laboratory control was performed: general urine analysis, urine bacteriological examination, clinical analysis of vaginal smears, analysis of vaginal microbiota by quantitative PCR Results. In the group of our patients, the distributions by age and gestational age differed from normal, the mean values are presented by the median and were 29 years and 14 weeks, respectively. Already had children – 13 (44.8%) women. In total, 35 microorganisms were isolated in a diagnostically significant titer. Most of the representatives of the Enterococcaceae family were traditionally 57.1%. At the time of inclusion, the median pyuria was 2.5 μl and exceeded the reference values only in 10.3% of patients. Clinical examination of vaginal smears revealed no inflammatory changes. However, an assessment of the vaginal microbiota showed the presence of dysbiosis due to an increase in the amount of obligate-anaerobic microflora in 58.6% and vaginal candidiasis in 10.3% of pregnant women. After 2 months, the 28 pregnant women remaining in the study had no episodes of symptomatic urinary infection. During the herbal drug therapy, there was a decrease in diagnostically significant bacteriuria and signs of the inflammatory process in all patients. The frequency of vaginal dysbiosis was recorded in 10.7% of pregnant women (р>0,05). Conclusion. Thus, our preliminary results shows that the use of Canephron N in pregnant women with asymptomatic bacteriuria (ABU) may be an effective alternative approach comparing the use of antibiotics. The treatment with Canephron N promotes the normalization of the urinary tract microflora and save the intactness of the saprophytic flora, in contrast to antibacterial drugs, and this is especially important in the paradigm of the antibiotics stewardship and the fight against growing antibiotic resistance. Comparative results of the use of antibacterial agents and Canephron N will be analyzed in the next publication, on the basis of which final conclusions will be drawn about the advisability of using herbal medicines to control bacteriuria in pregnant women Conclusion. We have obtained encouraging results from the use of Canephron-N® in patients with asymptomatic bacteriuria in pregnant. To obtain an evidence base of a recommendatory level, it is advisable to increase the number of observations.