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

Obstet Gynecol. 2003 Mar;101(3):516-22. doi: 10.1016/s0029-7844(02)03054-5.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravaginal
  • Adolescent
  • Adult
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / therapeutic use*
  • Birth Weight
  • Clindamycin / administration & dosage
  • Clindamycin / therapeutic use*
  • Double-Blind Method
  • England
  • Female
  • Humans
  • Obstetric Labor, Premature / prevention & control*
  • Pregnancy
  • Pregnancy Complications, Infectious / prevention & control*
  • Pregnancy Outcome
  • Pregnancy Trimester, Second
  • Treatment Outcome
  • Vagina / microbiology


  • Anti-Bacterial Agents
  • Clindamycin