The Efficacy of Vaginal Clindamycin for the Treatment ofAbnormal Genital Tract Flora in Pregnancy

Abstract

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 < 0.0001). 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.

A Review of Current Intravaginal Drug Delivery Approaches Employed for the Prophylaxis of HIV/AIDS and Prevention of Sexually Transmitted Infections

“…The study found that the spermicidal activity and the diffusion of the agent changed with the pH and osmolarity of the formulation. Recently, a gel microemulsion-based spermicide formulation, phenyl phosphate derivative of zidovudine, with anti-HIV effect, has been developed (56). Multiple intravaginal applications of this drug as a microemulsion gel formulation did not cause any damage in the vaginal epithelium in the rabbit model (57-59).…”

Infection and antibiotics in the aetiology, prediction and prevention of preterm birth

“…In addition, re-screening and re-treating in pregnancy may be helpful, since an initial course of CVC cured or improved BV in 88% of pregnant women but a second course some 3 -6 weeks later was still able to cure or improve BV in 50% of those who still had the condition (Lamont and Taylor-Robinson 2012). Oral clindamycin has been associated with pseudomembranous colitis, however many oral antibiotics carry the same risk and, as only 4% of CVC is absorbed systemically (Borin et al 1995), it appears safer (Lamont et al 2003b). …”

“…To date, no study has compared oral clindamycin with CVC in pregnancy, but it may be that if administered early in pregnancy or pre-pregnancy before ascending colonisation is considered likely, then CVC may be more appropriate than oral therapy. In pregnancy, the cure rate of oral clindamycin is 90% (Ugwumadu et al 2004) and the cured/ improved rate for CVC using the most stringent of diagnostic criteria is 70.8% (Lamont et al 2003b). Th is cure rate compares more favourably with the 40 -77% cure rates following a 2-day course of metronidazole (McDonald et al 1994;Carey et al 2000).…”

“…Persistent or recurrent BV is seen in approximately 10 -30%, and yet few studies have re-treated their patients (Lamont et al 2003c;Kiss et al 2004;Larsson et al 2006). In the study by Lamont et al (2003b), using stringent diagnostic criteria (Nugent score 10 plus all four elements of the Amsel composite clinical criteria), 70.8% of women who received CVC were cured/improved at 20 -24 days post-treatment compared with only 12% in the placebo group. Recurrence rates in those CVC patients successfully treated were approximately 6% at 6 weeks post-baseline and 10% at 28 -34 weeks.…”

“…In the study by Kekki et al (2001), although it was not possible to demonstrate an overall benefi t of clindamycin vaginal cream (CVC) versus placebo, in those women with persistent or recurrent BV, the rate of peripartum infection was three times higher and PTB was nine times higher compared with those with BV cure. In pregnancy, it has been demonstrated that clindamycin is highly eff ective in curing or improving BV, according to two diagnostic criteria (Food and Drug Administration recommendations), three diagnostic criteria (historical precedence pertaining to Amsel clinical criteria) or fi ve diagnostic criteria (stringency of diagnosis) (Lamont et al 2003b). In contrast, although a number of studies have assessed the effi cacy of metronidazole for the treatment of BV in pregnancy, no study has simultaneously used such a comprehensive range of diff erent diagnostic criteria to assess the effi cacy of metronidazole (Morales et al 1994;McDonald et al 1997;Carey et al 2000;Klebanoff et al 2001).…”