Premature Birth, Vaginal Flora
Conditions
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.
Interventions
OTHERvaginal 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.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early diagnosis of preterm birth using vaginal microbiota analysis | at birth | prematurity yes/no (define by birth \<37WG) |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed