OBJECTIVE: The purpose of this study was to determine the effectiveness of treatment over time for bacterial vaginosis in pregnancy and the probability of spontaneous resolution with placebo. STUDY DESIGN:Women with asymptomatic bacterial vaginosis on Gram stain were assigned randomly at 16 to 23 weeks of gestation to receive two 2-g doses of metronidazole or placebo 48 hours apart and were re-evaluated for changes in Gram stain score on one occasion > or =2 weeks later. RESULTS: Of 658 women who underwentmetronidazole therapy, treatment was successful (score, <7) in 78% of those women who were seen at 2 to 3.9 weeks of gestation, which was similar to women seen > or =10 weeks after treatment. In 683 women who underwentplacebo therapy, spontaneous resolution increased significantly from 13% at 2 to 3.9 weeks of gestation to 36% at > or =10 weeks of gestation. Spontaneous resolution was more common with lower vaginal pH or lactobacilli on Gram stain at the time of random assignment. CONCLUSION: The effectiveness of metronidazole therapy of bacterial vaginosis persists for > or =10 weeks. Women who underwent placebo therapy had significant remission of bacterial vaginosis over > or =10 weeks. Remission was more common when the initial vaginal microbiologic disturbances were less severe.
RCT Entities:
OBJECTIVE: The purpose of this study was to determine the effectiveness of treatment over time for bacterial vaginosis in pregnancy and the probability of spontaneous resolution with placebo. STUDY DESIGN:Women with asymptomatic bacterial vaginosis on Gram stain were assigned randomly at 16 to 23 weeks of gestation to receive two 2-g doses of metronidazole or placebo 48 hours apart and were re-evaluated for changes in Gram stain score on one occasion > or =2 weeks later. RESULTS: Of 658 women who underwent metronidazole therapy, treatment was successful (score, <7) in 78% of those women who were seen at 2 to 3.9 weeks of gestation, which was similar to women seen > or =10 weeks after treatment. In 683 women who underwent placebo therapy, spontaneous resolution increased significantly from 13% at 2 to 3.9 weeks of gestation to 36% at > or =10 weeks of gestation. Spontaneous resolution was more common with lower vaginal pH or lactobacilli on Gram stain at the time of random assignment. CONCLUSION: The effectiveness of metronidazole therapy of bacterial vaginosis persists for > or =10 weeks. Women who underwent placebo therapy had significant remission of bacterial vaginosis over > or =10 weeks. Remission was more common when the initial vaginal microbiologic disturbances were less severe.
Authors: Brenna Anderson; Yuan Zhao; William W Andrews; Donald J Dudley; Baha Sibai; Jay D Iams; Ronald J Wapner; Michael W Varner; Steve N Caritis; Mary Jo O'Sullivan Journal: Obstet Gynecol Date: 2011-04 Impact factor: 7.661
Authors: Emilia H Koumans; Sandra D Lane; Richard Aubry; Kathleen Demott; Noah Webster; Brooke A Levandowski; Stuart Berman; Lauri E Markowitz Journal: Matern Child Health J Date: 2011-10
Authors: Caroline Mitchell; Lisa E Manhart; Kathy Thomas; Tina Fiedler; David N Fredricks; Jeanne Marrazzo Journal: Infect Dis Obstet Gynecol Date: 2012-05-30
Authors: Leticia Krauss-Silva; Maria Elizabeth L Moreira; Mariane B Alves; Maria R Rezende; Alcione Braga; Karla G Camacho; Maria Rosa R Batista; Clarisse Savastano; Antonio Almada-Horta; Fernando Guerra Journal: Reprod Health Date: 2010-06-30 Impact factor: 3.223
Authors: Leticia Krauss-Silva; Maria Elizabeth L Moreira; Mariane B Alves; Alcione Braga; Karla G Camacho; Maria Rosa R Batista; Antonio Almada-Horta; Maria R Rebello; Fernando Guerra Journal: Trials Date: 2011-11-08 Impact factor: 2.279