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Infect Dis Obstet Gynecol ; 11(4): 181-9, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-15108863

RESUMO

OBJECTIVE: To assess the efficacy of 2% clindamycin vaginal cream (CVC) to treat bacterial vaginosis (BV) in pregnancy. METHODS: A prospective, randomized, double-blind, placebo-controlled, tricenter study. Four hundred and four women with BV on Gram stain at their first antenatal clinic visit were randomized to receive a 3-day course of 2% CVC or placebo. The outcome was assessed using an intention to treat analysis at 3 weeks and 6 weeks post-treatment according to three different diagnostic methods based on five criteria (Gram stain and all four elements of clinical composite criteria: vaginal discharge, abnormal vaginal pH, clue cells, amine odor), three criteria (vaginal pH, clue cells, amine odor) or two criteria (clue cells and amine odor) to reflect stringency of diagnosis, historical precedence and government agency recommendations respectively. RESULTS: Using five diagnostic criteria, 18% of CVC patients were cured and 70.8% either cured and/or improved compared to 1.6% and 12% of placebo patients respectively (p < 0.0001). Using three diagnostic criteria, 44.8% of CVC patients were cured and 77.3% were either cured and/or improved compared to 9.3% and 28.8% of placebo patients respectively (p < 0.000 1). Using two diagnostic criteria, 75.0% of CVC patients were cured compared to 18.0% of placebo patients (p < 0.0001 ). Recurrence rates in those CVC patients successfully treated were approximately 6% at 6 weeks post baseline and 10% at 28 to 34 weeks gestation. CONCLUSIONS: A 3-day course of CVC appears to be well tolerated by the mother and statistically significantly more efficacious than placebo in the treatment of BV during the second trimester of pregnancy.


Assuntos
Clindamicina/uso terapêutico , Complicações Infecciosas na Gravidez/tratamento farmacológico , Vaginose Bacteriana/tratamento farmacológico , Vaginose Bacteriana/microbiologia , Administração Intravaginal , Adolescente , Adulto , Distribuição de Qui-Quadrado , Método Duplo-Cego , Esquema de Medicação , Feminino , Seguimentos , Bactérias Gram-Negativas/efeitos dos fármacos , Bactérias Gram-Positivas/efeitos dos fármacos , Humanos , Gravidez , Complicações Infecciosas na Gravidez/diagnóstico , Resultado da Gravidez , Probabilidade , Estudos Prospectivos , Valores de Referência , Medição de Risco , Resultado do Tratamento , Cremes, Espumas e Géis Vaginais , Esfregaço Vaginal
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