A prospective, randomized, clinical study to compare the clinical safety, effectiveness, and cost of oral ofloxacin/clindamycin vs intravenous clindamycin/gentamicin for the treatment of postpartum endomyometritis

Abstract

Objective: The primary objective of this prospective, randomized, clinical study was to compare the safety, clinical and microbiologic efficacy, and cost of oral ofloxacin in combination with clindamycin vs intravenous (IV) clindamycin/gentamicin in the early empiric treatment for hospitalized patients with mild to moderate postpartum endomyometritis. The secondary objective is to reduce total hospital and patient treatment cost. Postpartum endomyometritis is a major cause of infectious morbidity in the obstetric patient. It is the most common complication associated with cesarean delivery. Careful timing and amniotomy, limited vaginal examinations, and prophylactic antibiotics for cesarean section delivery may help to reduce the incidence and severity of endomyometritis. Endomyometritis is caused by bacteria that compose the normal cervicovaginal flora. These are anaerobic gram-positive cocci (Peptostreptococcus and Peptococcus), aerobic streptococci (Group B Streptococci and enterococci), Enterobacteriaceae, Bacteroides (B. fragilis, B. bivius, and B. disiens), and clostridium species.Ofloxacin is a synthetic broad-spectrum antibacterial agent for intravenous and oral administration. Following oral administration, the bioavailability in tablet form is 98% with maximum serum concentrations in 1 to 2 hours. Steady state concentrations are achieved after 4 doses. Ofloxacin usually is bactericidal in action. A synthetic broad-spectrum antibacterial agent for intravenous and ora…