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Influence of early self‐diagnosis and treatment of bacterial vaginosis on preterm birth rate
Author(s) -
Sungkar Ali,
Purwosunu Yuditiya,
Aziz Muhamad F.,
Pratomo Hadi,
Sutrisna Bambang,
Sekizawa Akihiko
Publication year - 2012
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2012.01.007
Subject(s) - medicine , bacterial vaginosis , metronidazole , randomized controlled trial , obstetrics , gram staining , gynecology , predictive value , vaginal disease , gold standard (test) , vagina , antibiotics , surgery , microbiology and biotechnology , biology
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 .