Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis.

The main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth.

The hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%.

Eligibility criteria

Qualifiers

Pregnant women over 18 years of age

Pregnant woman after 8 weeks and before 18 weeks of gestation (i.e. >=8 weeks and ≤ 18 weeks)

Woman who has understood the study process and objectives and agreed to sign an informed consent form;

With a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population) (A late miscarriage or late fetal loss mean foetal loss between 14 and 22 weeks of gestation)

Disqualifiers

- 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;

Trial design

Treatments tested in this trial

  • Vaginal flora abnormalities screening and quantification using molecular biology technique
  • Azithromycine
  • Ceftriaxone
  • Metronidazole
  • Clotrimazole, Vaginal
  • Usual Care

Treatment groups

1,292 Participants
are divided into 2 treatment groups

Locations

This trial has no locations