title: Effect of intravaginal clindamycin cream on pregnancy outcome and on abnormal vaginal microbial flora of pregnant women.
abstract: OBJECTIVE
  To determine whether intravaginal clindamycin cream reduces the incidence of abnormal pregnancy outcome in women with abnormal vaginal microbial flora graded as intermediate or BV and to investigate the effect of the antibiotic on vaginal microbial flora.
  
  
  METHODS
  A prospective cohort study of pregnant women in an antenatal clinic of a district general hospital. The subjects were 268 women who had abnormal vaginal microbial flora at first clinic visit by examination of a Gram-stained vaginal smear and 34 women with a normal vaginal flora. Two hundred and thirty-seven women were evaluable. Women with abnormal Gram-stained smears (graded as II or III) on clinic recall were randomised to receive treatment (intravaginal clindamycin cream) or placebo and followed to assess outcome of pregnancy, vaginal flora, and detection of Mycoplasma hominis and Ureaplasma urealyticum after treatment.
  
  
  RESULTS
  Abnormal outcomes of pregnancy were not significantly different in treated and placebo groups by Chi square (P = 0.2). However, women with grade III flora responded better to clindamycin than women with grade II flora by numbers of abnormal outcomes (P = 0.03) and return to normal vaginal flora (P = 0.01) (logistic regression analysis model). This may be due to differences in vaginal bacterial species in these grades. Women whose abnormal vaginal flora had spontaneously returned to normal on follow-up and were therefore not treated (revertants) had as many abnormal outcomes as placebos suggesting that damage by abnormal bacterial species occurred early in pregnancy.
  
  
  CONCLUSIONS
  Gram-stain screening distinguishing grade II from grade III flora may be helpful in prescribing treatment other than clindamycin for women with grade II flora. Earlier diagnosis and treatment may be more effective in preventing an abnormal outcome, possibly as soon as pregnancy is diagnosed or even offered as a pre-conception screen.
authors.affiliation: MRC Sexually Transmitted Diseases Research Group, Department of Medical Microbiology, Imperial College School of Medicine, London, United Kingdom. irosenstein@phls.nhs.uk
authors.forename: I J
authors.initials: IJ
authors.lastname: Rosenstein
authors.forename: D J
authors.initials: DJ
authors.lastname: Morgan
authors.forename: R F
authors.initials: RF
authors.lastname: Lamont
authors.forename: M
authors.initials: M
authors.lastname: Sheehan
authors.forename: C J
authors.initials: CJ
authors.lastname: Doré
authors.forename: P E
authors.initials: PE
authors.lastname: Hay
authors.forename: D
authors.initials: D
authors.lastname: Taylor-Robinson
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D001419:Bacteria / Q000187:drug effects; D002981:Clindamycin / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000382:microbiology*; D011256:Pregnancy Outcome; D011446:Prospective Studies; D014621:Vagina / Q000382:microbiology*; D014622:Vaginal Creams, Foams, and Jellies; D016585:Vaginosis, Bacterial / Q000145:classification / Q000150:complications* / Q000188:drug therapy / Q000382:microbiology
chemical_list: D000900:Anti-Bacterial Agents; D014622:Vaginal Creams, Foams, and Jellies; D002981:Clindamycin