Influence of early self-diagnosis and treatment of bacterial vaginosis on preterm birth rate

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%. Conclusion: Early self-diagnosis and treatment of BV did not reduce the preterm birth rate of the study group. ClinicalTrial.gov number: NCT01232192.