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Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota

RecruitingNAAges 18 Years - anyFemaleUniversity Hospital, Clermont-Ferrand
NCT06265740 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pregnant women Admitted to the Clermont-Ferrand University Hospital maternity ward from 14 weeks' gestation onwards * For threat of preterm birth (PTB) characterized by contractile activity and/or cervical changes, or for premature rupture of fetal membranes (PROM) * And in need of vaginal swabbing * Single or multiple pregnancy * Able to understand and object to the study * Covered by a French social security scheme. * Give informed consent for the study Exclusion Criteria: * Patient under guardianship, curatorship or safeguard of justice * Patient having received antibiotic therapy in the 2 weeks prior to admission
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What it tests

  • vaginal swab
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Where

1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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