Abstract
BackgroundInternational recommendations in favor of screening for vaginal infection in pregnancy are based on heterogeneous criteria. In most developed countries, the diagnosis of bacterial vaginosis is only recommended for women with high-risk of preterm birth. The Nugent score is currently used, but molecular quantification tools have recently been reported with a high sensitivity and specificity. Their value for reducing preterm birth 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 Gardnerella vaginalis) before 20 weeks of gestation in pregnant women 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 preterm birth.Methods/DesignA multicenter, open-label randomized controlled trial (RCT) will be conducted in which 20 French obstetrics and gynecology centers will recruit eligible pregnant women at less than 20 weeks gestation with singleton pregnancy and with a low-risk factor for preterm birth. 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 preterm birth before 37 weeks. Secondary endpoints will include ICER per avoided preterm birth before 24, 28 and 32 weeks, obstetrical outcomes, neonatal outcomes, rates of treatment failure and recurrence episodes for positive women. Uncertainty surrounding these estimates will be addressed using nonparametric bootstrapping and represented using cost-effectiveness acceptability curves. A total of 6,800 pregnant women will be included.DiscussionThis 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 women. National and international recommendations could be updated based on the findings of this study.Trial registrationClinicalTrials.gov: NCT02288832 (registration date: 30 October 2014); Eudract: 2014-001559-22.
Highlights
International recommendations in favor of screening for vaginal infection in pregnancy are based on heterogeneous criteria
Pregnant women with bacterial vaginosis (BV) have an increased risk of preterm birth compared to women without BV, and the risk of preterm birth is higher if BV occurs in the early stage of pregnancy [5]
Written Informed consent will be obtained from all subjects before inclusion. This is the first large randomized controlled trial assessing the cost-effectiveness of a screen-and-treat program of molecular flora vaginal anomalies during the first trimester in pregnant women with low risk of preterm birth
Summary
This is the first large randomized controlled trial assessing the cost-effectiveness of a screen-and-treat program of molecular flora vaginal anomalies during the first trimester in pregnant women with low risk of preterm birth. Due to the lack of data concerning the early phase of pregnancy, the authors may have underestimated the effectiveness of a universal screen-and-treat program in reducing the rate of “very preterm birth” (28 to 32 weeks) These subdivisions into “very preterm” and “moderate” or “late preterm” (that is, 32 to less than 37 completed weeks of gestation) are important since decreasing gestational age is associated with increasing mortality, intensity of neonatal care required, and increasing costs [42]. Given the need for scientific evidence (in terms of both efficacy and economic) regarding bacterial vaginosis screening in a population with low-risk factors for preterm birth, our analysis should be useful for clinicians and other healthcare decision makers involved in managing care of pregnant women.
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