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Infectious Diseases in Obstetrics and Gynecology
Volume 11 (2003), Issue 4, Pages 181-189
The Efficacy of Vaginal Clindamycin for the Treatment of Abnormal Genital Tract Flora in Pregnancy
1Northwick Park and St Mark's NHS Trust, Harrow, Middlesex, United Kingdom
2University of Sheffield, Sheffield, United Kingdom
3Manchester Centre for Sexual Health, Manchester Royal Infirmary, Manchester, United Kingdom
4St George's Hospital, Tooting, London SW17, United Kingdom
5Imperial College School of Science, Technology and Medicine, London, United Kingdom
6Department of Obstetrics and Gynaecology, Northwick Park and St Mark's NHS Trust, Watford Road, Harrow, Middlesex, London HA1 3UJ, United Kingdom
Received 29 October 2002; Accepted 16 July 2003
Copyright © 2003 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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.