title: Influence of early self-diagnosis and treatment of bacterial vaginosis on preterm birth rate.
abstract: OBJECTIVE
  To assess whether early self-diagnosis and treatment of bacterial vaginosis (BV) could lower the preterm birth rate among a group of Indonesian women.
  
  
  METHODS
  A randomized controlled trial of 331 pregnant women (14-18 weeks) was conducted. Participants were randomly assigned to either the active model group (n=176) or the control group (n=155). Women in the active model group were equipped with a kit to self-evaluate vaginal pH; those with a positive test result were treated with a twice daily dose of 500 mg of metronidazole for 7 days. The primary end point was preterm birth rate.
  
  
  RESULTS
  There were 6 (3.8%) and 8 (5.4%) preterm births in the active model and control groups, respectively (P=0.468). No spontaneous abortions were recorded in either group. When compared with the gold standard (Gram staining), the vaginal acidity test had low ability to detect BV, with 88.7% specificity and 36.9% sensitivity. The positive predictive value of the test was 35.0% PPV, while the negative predictive value was 89.4%.
  
  
  CONCLUSIONS
  Early self-diagnosis and treatment of BV did not reduce the preterm birth rate of the study group. ClinicalTrial.govnumber:NCT01232192.
authors.affiliation: Department of Obstetrics and Gynecology, University of Indonesia, Cipto Mangunkusumo National Hospital, Jakarta, Indonesia.
authors.forename: Ali
authors.initials: A
authors.lastname: Sungkar
authors.forename: Yuditiya
authors.initials: Y
authors.lastname: Purwosunu
authors.forename: Muhamad F
authors.initials: MF
authors.lastname: Aziz
authors.forename: Hadi
authors.initials: H
authors.lastname: Pratomo
authors.forename: Bambang
authors.initials: B
authors.lastname: Sutrisna
authors.forename: Akihiko
authors.initials: A
authors.lastname: Sekizawa
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use; D059026:Diagnostic Self Evaluation; D005260:Female; D005840:Gentian Violet; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007214:Indonesia / Q000453:epidemiology; D008795:Metronidazole / Q000627:therapeutic use; D010353:Patient Education as Topic; D010619:Phenazines; D011237:Predictive Value of Tests; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis* / Q000188:drug therapy*; D047928:Premature Birth / Q000453:epidemiology*; D012307:Risk Factors; D014621:Vagina / Q000737:chemistry / Q000382:microbiology; D016585:Vaginosis, Bacterial / Q000175:diagnosis* / Q000188:drug therapy*
chemical_list: D000890:Anti-Infective Agents; C035863:Gram's stain; D010619:Phenazines; D008795:Metronidazole; D005840:Gentian Violet