[Ketoconazole and clindamycin efficacy vs oral clindamycin in premature membranes rupture prevention]. / Eficacia del ketoconazol y la clindamicina vaginal vs clindamicina oral en la prevención de la rotura prematura de membranas.

BACKGROUND: Vulvovaginitis is one of the main causes of premature membrane rupture. OBJECTIVE: To evaluate effectiveness of a combination of ketoconazole (400 mg) and clindamycin (100 mg) in vaginal tablets, compared with clindamicyn alone (600 mg/daily) orally, for six days, to prevent premature membrane rupture in patients with vulvovaginitis. PATIENTS AND METHOD: Longitudinal, prospective, comparative, randomized, double-blind, double-dummy study in patients older than 18 years, during them third trimester of normoevolutive pregnancy with symptomatic vulvovaginitis. Patients were monitored as out patient. Genital secretion culture and fresh studies were made. Signs and symptoms were evaluated in regular intervals: 4, 7 and 11 days. Pregnancy control was performed every three weeks, until childbirth or premature membrane rupture. RESULTS: 105 patients were included: 53 in the group of ketoconazole and clindamicyn (1), and 52 in the group of clindamycin alone (2). Symptoms were similar in both groups of treatment, without statistically significant differences. A case of group 2 has premature membrane rupture (p = 0.495). C. albicans was cultured in 35% of group 2 and in 11% of group 2. No adverse events with treatments were reported. CONCLUSIONS: The combination of ketoconazole and cindamycin was effective to prevent premature membrane rupture in patients with vulvovaginitis.