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 .