Screen-and-treat program by point-of-care of Atopobium vaginae and XXXX in preventing @entity600 (AuTop trial): study protocol for a randomized controlled trial.

@entity1 @entity8439 @entity600 @entity281 @entity6981
BACKGROUND: International recommendations in favor of screening for @entity281 in pregnancy are based on heterogeneous criteria. In most developed countries, the diagnosis of @entity6981 is only recommended for @entity1 with high-risk of @entity600 . The Nugent score is currently used, but molecular quantification tools have recently been reported with a high sensitivity and specificity. Their value for reducing @entity600 rates and related complications remains unexplored. This trial was designed to assess the cost-effectiveness of a systematic screen-and-treat program based on a point-of-care technique for rapid molecular diagnosis, immediately followed by an appropriate antibiotic treatment, to detect the presence of abnormal vaginal flora (specifically, Atopobium vaginae and @entity8439 ) before 20  weeks of gestation in pregnant @entity1 in France. We hypothesized that this program would translate into significant reductions in both the rate of preterm births and the medical costs associated with @entity600 . METHODS/DESIGN: A multicenter, open-label randomized controlled trial (RCT) will be conducted in which 20 French obstetrics and gynecology centers will recruit eligible pregnant @entity1 at less than 20  weeks gestation with singleton pregnancy and with a low-risk factor for @entity600 . Interventions will include a) an experimental group that will receive a systematic rapid screen-and-treat program from a point-of-care analysis using a molecular quantification method and b) a control group that will receive usual care management. Randomization will be in a 1:1 allocation ratio. The primary endpoint that will be assessed over a period of 12  months will be the incremental cost-effectiveness ratio (ICER) expressed as cost per avoided @entity600 before 37  weeks. Secondary endpoints will include ICER per avoided @entity600 before 24, 28 and 32  weeks, obstetrical outcomes, neonatal outcomes, rates of treatment failure and recurrence episodes for positive @entity1 . Uncertainty surrounding these estimates will be addressed using nonparametric bootstrapping and represented using cost-effectiveness acceptability curves. A total of 6,800 pregnant @entity1 will be included. DISCUSSION: This appropriate randomized controlled design will provide insight into the cost-effectiveness and therefore the potential cost savings of a rapid screen-and-treat strategy for molecular abnormal vaginal flora in pregnant @entity1 . National and international recommendations could be updated based on the findings of this study. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02288832 (registration date: 30 October 2014); Eudract: 2014-001559-22.
