OBJECTIVE: To evaluate the efficacy of single-dose fosfomycin tromethamine (FT) treatment in pregnant women with uncomplicated lower urinary tract infection (UTI). STUDY DESIGN: In this study, 421 pregnant women with established, symptomatic, uncomplicated lower UTI were randomly allocated to receive either a single dose of FT (Monurol®, Zambon Group S.p.A, Milan-ITALY) (n=217) or a 7-day course of nitrofurantoin (n=204). The treatment was found to be effective if urine culture was negative 15 days after therapy. RESULTS: Microbiological cure was achieved in 205 (94.5%) patients treated with FT and 164 (80.4%) patients treated with nitrofurantoin (p