Status:
RECRUITING
Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Premature Birth
Vaginal Flora
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
There is currently no reliable clinical or biological diagnosis to predict premature birth. Recent work using metagenomic data analysis coupled with artificial intelligence approaches suggests that th...
Eligibility Criteria
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
Key Trial Info
Start Date :
March 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06265740
Start Date
March 29 2024
End Date
November 1 2025
Last Update
February 12 2025
Active Locations (1)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France