Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota

Recruiting now · Not applicable

Conditions studied: Premature Birth, Vaginal Flora

In brief

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).

Key facts

Study ID

NCT06265740

Run by

University Hospital, Clermont-Ferrand

People needed

150

Starts

2024-03-29

Expected to finish

2025-11-01

Last updated by the study team

2025-02-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patient under guardianship, curatorship or safeguard of justice
• Patient having received antibiotic therapy in the 2 weeks prior to admission

Where it is running

• CHU de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)

Full record on ClinicalTrials.gov

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