@article{PAR00013857,
  title = {{S}creen-and-treat program by point-of-care of {A}topobium vaginae and {G}ardnerella vaginalis in preventing preterm birth ({A}u{T}op trial) : study protocol for a randomized controlled trial},
  author = {{B}retelle, {F}. and {F}enollar, {F}. and {B}aumstarck, {K}. and {F}ortanier, {C}. and {C}ocallemen, {J}. {F}. and {S}erazin, {V}. and {R}aoult, {D}idier and {A}uquier, {P}. and {L}oubiere, {S}.},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground: {I}nternational recommendations in favor of screening for vaginal infection in pregnancy are based on heterogeneous criteria. {I}n most developed countries, the diagnosis of bacterial vaginosis is only recommended for women with high-risk of preterm birth. {T}he {N}ugent score is currently used, but molecular quantification tools have recently been reported with a high sensitivity and specificity. {T}heir value for reducing preterm birth rates and related complications remains unexplored. {T}his 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, {A}topobium vaginae and {G}ardnerella vaginalis) before 20 weeks of gestation in pregnant women in {F}rance. {W}e hypothesized that this program would translate into significant reductions in both the rate of preterm births and the medical costs associated with preterm birth. {M}ethods/{D}esign: {A} multicenter, open-label randomized controlled trial ({RCT}) will be conducted in which 20 {F}rench 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. {I}nterventions 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. {R}andomization will be in a 1: 1 allocation ratio. {T}he 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. {S}econdary 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. {U}ncertainty 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. {D}iscussion: {T}his 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. {N}ational and international recommendations could be updated based on the findings of this study.},
  keywords = {{P}regnancy ; bacterial vaginosis ; preterm birth ; screen-and-treat ; strategy ; cost-effectiveness analysis ; point-of-care ; molecular diagnosis ; antibiotic treatment ; randomized controlled trial ; {A}topobium vaginae ; {G}ardnerella vaginalis},
  booktitle = {},
  journal = {{T}rials},
  volume = {16},
  numero = {},
  pages = {art. 470},
  ISSN = {1745-6215},
  year = {2015},
  DOI = {10.1186/s13063-015-1000-y},
  URL = {https://www.documentation.ird.fr/hor/{PAR}00013857},
}