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.
RCT Entities:
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 CVCpatients 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 CVCpatients 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 CVCpatients were cured compared to 18.0% of placebo patients (p < 0.0001 ). Recurrence rates in those CVCpatients 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.
Authors: J A McGregor; J I French; W Jones; K Milligan; P J McKinney; E Patterson; R Parker Journal: Am J Obstet Gynecol Date: 1994-04 Impact factor: 8.661
Authors: Ronald F Lamont; Chia-Ling Nhan-Chang; Jack D Sobel; Kimberly Workowski; Agustin Conde-Agudelo; Roberto Romero Journal: Am J Obstet Gynecol Date: 2011-04-02 Impact factor: 8.661
Authors: Valence M K Ndesendo; Viness Pillay; Yahya E Choonara; Eckhart Buchmann; David N Bayever; Leith C R Meyer Journal: AAPS PharmSciTech Date: 2008-04-02 Impact factor: 3.246
Authors: Anne Cc Lee; Luke C Mullany; Mohammad Quaiyum; Dipak K Mitra; Alain Labrique; Parul Christian; Parvez Ahmed; Jamal Uddin; Iftekhar Rafiqullah; Sushil DasGupta; Mahmoodur Rahman; Emilia H Koumans; Salahuddin Ahmed; Samir K Saha; Abdullah H Baqui Journal: Lancet Glob Health Date: 2019-01 Impact factor: 38.927