Preterm birth is a major cause of mortality and long-term disability. Bacterial vaginosis (BV) is a frequent form of dysbiosis that is often asymptomatic and increases the risk of preterm birth. BV is usually diagnosed using conventional tools such as the Nugent score. Molecular diagnosis of BV has now been shown to be more reproducible and to provide a more accurate characterization of dysbiosis.
The main objective of this study is to evaluate the effectiveness of a self screen and treat strategy for vaginal flora dysbiosis, based on molecular point of care (POC) multiplex technology before 18 weeks' gestation, in reducing the rate of preterm birth among pregnant women at high risk, compared with usual care.
The hypothesis is that a Screen-and-Treat strategy using molecular biology among women with previous preterm or/and an history of late abortion could be effective in reducing preterm births by 40%.
Pregnant woman over 18 years of age;
Single intra uterine pregnancy after 8 weeks and before 18 weeks of gestation (i.e. ≥ 8 weeks and ≤ 18 weeks). Woman can present symptomatic vaginal discharge, or can be asymptomatic or symptomatic with regard to the diagnosis of bacterial vaginosis (BV) with usual technics;
preterm birth before 37 weeks of gestation (even if the preterm birth was following preterm rupture of membranes);
and / or late miscarriage or fetal loss (i.e. miscarriage or foetal loss between 14 and 22 weeks of gestation), even if one any of her last birth occurred at term.
- Woman of legal age under legal protection;
Women deprived of their freedom for administrative or legal reasons;
Woman who has not signed a consent form
Nulliparous;
Parallel
Vaginal flora abnormalities screening and quantification using molecular biology technique
Diagnostic testVaginal self-sampling is a simple and validated method of sampling used for the molecular biology technique and the quantification of microorganisms involved in vaginal flora imbalance bacteriosis.The patient performs a self-sampling with a cotton swab transferred into a transport medium tube. The sample is sent to the laboratory where Multiplex Point of Care polymerase chain reaction (PCR) is performed.
Azithromycin
DrugIn case of Chlamydia trachomatis infections: Azithromycin 1 g per os during the second and third trimester of pregnancy .
Ceftriaxone
DrugIn case of Neisseria gonorrhoeae infections: Ceftriaxone 1 g IM as a single dose.
Metronidazole
DrugIn case of Trichomonas vaginalis infections: Metronidazole 500 mg 2 times/day for 7 days, whatever the trimester of pregnancy is . In case of Gardnerella vaginalis infection: Metronidazole 500 mg orally 2 times/day for 7 days . In case of Atopobium/Fannyhessea vaginae and/or Gardnerella vaginalis positivity: Metronidazole 500 mg orally 2 times/day for 7 days .
Clotrimazole
DrugIn case of Candida albicans infection: 500 mg in a single dose. If necessary, this treatment could be repeated up to 6 times .
Doxycyclin
DrugDuring first trimester of pregnancy ,in case of Chlamydia trachomatis infections at a dose of 200 mg/day 7 days .
The rate of preterm birth
The primary endpoint will be the rate of preterm birth before 37 weeks of gestation, which will be compared between the innovative group (Group A experimental) and the standard group (Group B Usual care).
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