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ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynaecology, Northwick Park and St. Marks Hospital, London; Imperial College School of Medicine, London; Department of Obstetrics and Gynaecology, Jessops Hospital for Women, Sheffield; and Manchester Centre for Sexual Health, Manchester Royal Infirmary, Manchester, United Kingdom.
Address reprint requests to: Ronald F. Lamont, DM, FRCOG, Northwick Park and St. Marks Hospital, Department of Obstetrics & Gynaecology, Watford Road, Harrow, Middlesex, London, HA1 3UJ, United Kingdom; E-mail: pauline.mills{at}nwlh.nhs.uk.
OBJECTIVE: To assess the ability of clindamycin vaginal cream to reduce the incidence of preterm birth in women with abnormal genital tract flora in the second trimester of pregnancy.
METHODS: This was a randomized, double-blind, placebo-controlled, tricenter study. A total of 409 women with abnormal genital tract flora on Gram stain of vaginal secretions at 1320 weeks gestation were randomized to receive a 3-day course of clindamycin vaginal cream or placebo. Those women who still had abnormal vaginal flora 3 weeks later received a 7-day course of the original study drug (ie, either clindamycin vaginal cream or placebo as per original randomization). The primary outcome measure was the incidence of preterm birth.
RESULTS: There was a statistically significant reduction in the incidence of preterm birth in the clindamycin vaginal cream group (4%) compared with placebo (10%) (P < .03). Significantly more babies born preterm (63%) required admission to the neonatal intensive care unit compared with term infants (4%) (P < .001).
CONCLUSION: A 2% clindamycin vaginal cream, when compared with placebo administered to women with abnormal genital tract flora before 20 weeks gestation, can reduce the incidence of preterm birth by 60% and hence the need for neonatal intensive care.
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