Clinical and cervical cytokine response to treatment with oral or vaginal metronidazole for bacterial vaginosis during pregnancy: a randomized trial

Obstet Gynecol. 2003 Sep;102(3):527-34. doi: 10.1016/s0029-7844(03)00566-0.


Objective: To compare the efficacy of oral versus vaginal metronidazole treatment in pregnant women with bacterial vaginosis, and to compare cytokine profiles (interleukin-1beta, -6, and -8) in the cervical secretions of these women before and after treatment.

Methods: Pregnant women with bacterial vaginosis diagnosed both by Gram stain and clinical criteria were randomized to receive oral (n=52) or vaginal (n=50) metronidazole therapy. Cervical specimens for cytokine analysis and vaginal fluid for evaluation of bacterial vaginosis were obtained at baseline and 4 weeks after treatment.

Results: There was no significant difference in therapeutic cure rates (defined as a Gram stain score of 0-3 and the absence of all four clinical signs of bacterial vaginosis) between the two groups (71% and 70% for the oral and vaginal groups, respectively, P=1.0). Cervical levels of interleukin-1beta, -6, and -8 were significantly lower after treatment among the 72 women cured of bacterial vaginosis (P<.001, P=.001, and P=.02, respectively) but not among women who failed to respond to therapy. For interleukin-1beta and -6, a significant decrease in cytokine level was observed in both the oral and vaginal treatment groups.

Conclusion: One week of oral metronidazole and 5 days of intravaginal metronidazole are equally efficacious for treatment of bacterial vaginosis during pregnancy. The decrease in cervical interleukin-1beta, -6, and -8 levels among women who established a normal flora after treatment but not among those with persistent bacterial vaginosis suggests a direct linkage between vaginal flora abnormalities and elevated cervical levels of interleukin-1beta, -6, and -8.

Publication types

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

MeSH terms

  • Administration, Intravaginal
  • Administration, Oral
  • Adolescent
  • Adult
  • Cytokines / drug effects*
  • Cytokines / metabolism
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Gestational Age
  • Humans
  • Interleukin-1 / metabolism
  • Interleukin-6 / metabolism
  • Interleukin-8 / metabolism
  • Metronidazole / administration & dosage*
  • Pregnancy
  • Pregnancy Complications, Infectious / diagnosis
  • Pregnancy Complications, Infectious / drug therapy*
  • Pregnancy Outcome*
  • Probability
  • Reference Values
  • Severity of Illness Index
  • Treatment Outcome
  • Vaginosis, Bacterial / drug therapy*
  • Vaginosis, Bacterial / microbiology


  • Cytokines
  • Interleukin-1
  • Interleukin-6
  • Interleukin-8
  • Metronidazole