Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Early diagnosis of preterm birth using vaginal microbiota analysis
Study Overview
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 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).
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 there may be a vaginal microbiota signature during pregnancy that correlates with the occurrence of preterm birth. The aim of the study is to use biological samples to confirm the identification of these vaginal microbiota signatures as a means of predicting preterm birth.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
cohort of pregnant women at -risk of preterm delivery
vaginal swab
Intervention: vaginal swab (Other)
Outcomes
Primary Outcomes
Early diagnosis of preterm birth using vaginal microbiota analysis
Time Frame: at birth
prematurity yes/no (define by birth \<37WG)
Secondary Outcomes
No secondary outcomes reported