Actively Recruiting
Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
Led by University Hospital, Clermont-Ferrand · Updated on 2025-02-12
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pregnant women at risk of premature birth to evaluate if analyzing the vaginal microbiota using the RiboTaxa algorithm combined with neural network learning can help predict preterm delivery. This study addresses the lack of reliable clinical or biological methods for early diagnosis of premature birth by identifying specific vaginal microbiota signatures during pregnancy. Participants will have vaginal swabs taken as part of their routine care at Clermont-Ferrand University Hospital. During the swabbing procedure, two samples will be collected simultaneously: one for standard diagnosis and another for microbiota analysis. The study involves longitudinal follow-up of the women from 14 weeks of gestation onward, with a case-control comparison after birth based on whether premature birth occurs. Throughout the study, biological samples will be collected and analyzed, focusing on vaginal microbiota changes. Outcome measures include early diagnosis of preterm birth using vaginal microbiota analysis at birth. Participants are expected to provide informed consent and be covered by French social security. The study includes safety and follow-up until delivery, and participation lasts through the pregnancy period until birth.
CONDITIONS
Brief Title
Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women admitted to the Clermont-Ferrand University Hospital maternity ward from 14 weeks' gestation onwards
- At risk of preterm birth due to contractile activity and/or cervical changes, or premature rupture of fetal membranes
- In need of vaginal swabbing
- Single or multiple pregnancy
- Able to understand and agree to the study
- Covered by a French social security scheme
- Provided informed consent for the study
You will not qualify if you...
- Under guardianship, curatorship, or safeguard of justice
- Received antibiotic therapy in the 2 weeks prior to admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From 14 weeks' gestation until birth
Participants who require routine vaginal swabbing provide an additional swab for microbiota analysis to help predict preterm birth.
1 to 2 visits depending on clinical need
Trial Site Locations
Total: 1 location
1
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
Research Team
L
Lise Laclautre
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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