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


CONCLUSIONS
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.
Lamont
Ronald F
RF
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
Duncan
Sheila L B
SL
Mandal
Debashis
D
Bassett
Paul
P
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001724:Birth Weight; D002981:Clindamycin / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004739:England; D005260:Female; D006801:Humans; D007752:Obstetric Labor, Premature / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D011256:Pregnancy Outcome; D011262:Pregnancy Trimester, Second; D016896:Treatment Outcome; D014621:Vagina / Q000382:microbiology
D000900:Anti-Bacterial Agents; D002981:Clindamycin