Limitations
infections
INFECTIONS
This study has limitations. The AuTop trial was initially designed as a cost-effectiveness analysis, with the primary end point being the incremental cost-effectiveness ratio. However, because of a nonsignificant clinical outcome (denominator of the ratio), the incremental cost-effectiveness ratio could not ultimately be calculated. Thus, effectiveness and cost outcomes were reported separately.It was not possible to build a blinded study because women with positive test results in the experimental screen and treat group were required to receive treatment and iterative vaginal control swabs if positive from the study team. In addition, our scientific committee felt that it would be unethical to offer screening to all patients in both groups but not to treat patients in the control group.In our study, loss to follow-up was less than 5%, but 44 of 242 patients screened with BV (18%) did not receive treatment. This reflects the difficulties of a randomized trial nested within routine practice in the care of pregnant women and may lower the effectiveness of the screen and treat strategy.The composition of bacteria present in BV varies among individuals; other species may be frequently found. The possibility that some of these infections may have been treated by the antibiotics used was not investigated in our study. Although randomization should ensure that the groups are similar in terms of microbiota, this may be a limitation. In the study population, the burden of BV was lower than expected (7% instead of 10%), which may have resulted in an inconclusive statistical result for the primary intention-to-treat end point.The generalization of molecular diagnosis in clinical microbiology during the COVID-19 pandemic