Premature Birth Clinical Trial
— PREMABIOTEOfficial title:
Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
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).
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | November 2025 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early diagnosis of preterm birth using vaginal microbiota analysis | prematurity yes/no (define by birth <37WG) | at birth |
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