Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota

Condition(s) studied

Investigational drug(s) / intervention(s)

vaginal swab: Any pregnant woman attending the obstetrics department of Clermont-Ferrand University Hospital who requires a vaginal swab (VS) for her clinical situation (routine care) will be offered the study. If the participant accepts, the usual swab will be doubled and performed simultaneously in a single procedure using two swabs. The first swab will be sent to the laboratory and used for diagnosis. The second swab will be used for microbiota analysis.

Study summary

Objectives: to assess the relevance of the RiboTaxa algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population.

Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth).

Eligibility

Primary outcome measure(s)

• Early diagnosis of preterm birth using vaginal microbiota analysis — at birth
  prematurity yes/no (define by birth \<37WG)

Trial sites (1)

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