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Intravaginal clindamycin to reduce preterm birth in women with abnormal genital tract flora.

Author(s): Lamont RF, Duncan SL, Mandal D, Bassett P

Affiliation(s): Department of Obstetrics and Gynaecology, Northwick Park and St. Mark's Hospital, Watford Road, Harrow, Middlesex, London HA1 3UJ, United Kingdom. pauline.mills@nwlh.nhs.uk

Publication date & source: 2003-03, Obstet Gynecol., 101(3):516-22.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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 13-20 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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