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Obstetrics & Gynecology 2003;101:516-522
© 2003 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Intravaginal Clindamycin to Reduce Preterm Birth in Women With Abnormal Genital Tract Flora

Ronald F. Lamont, DM, FRCOG, Sheila L. B. Duncan, MD, FRCOG, Debashis Mandal, MBBS, FRCP and Paul Bassett, MSc

From the Department of Obstetrics and Gynaecology, Northwick Park and St. Mark’s 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. Mark’s 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 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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