Safety of Canephron® N for the treatment of urinary tract infections in the first trimester of pregnancy

Abstract

Background

Urinary tract infections (UTIs) are among the most commonly occurring bacterial infections, particularly in pregnant women. Canephron® N (Bionorica, Germany) is a phytotherapeutic medicinal product that has pleiotrophic effects on the urinary system, including diuretic, spasmolytic, anti-inflammatory, antimicrobial and nephroprotective effects. The purpose of this retrospective study was to assess the safety of Canephron® N when used in the first trimester of pregnancy for the treatment of UTIs.

Methods

This was a retrospective, multi-center study that evaluated the effects of Canephron® N in 384 women who had used the herbal drug during the first trimester of pregnancy (between 2004 and 2009), and whose pregnancies ended in live births. The endpoints assessed in this study were the presence of congenital defects in the newborn.

Results

There were no significant differences in the incidence of congenital malformations in newborns whose mothers had taken Canephron® N in the first trimester of pregnancy, compared to the national statistical data for the Kiev population during the same period. The majority of newborns (>65 %) whose mothers had received Canephron® N during the first trimester of pregnancy had Apgar scores of 8 or above, indicating an excellent safety status.

Conclusions

The results from our study indicate that the use of Canephron® N during the first trimester of pregnancy was not associated with any teratogenic, embryotoxic or fetotoxic effects on the fetus.