Predicting premature births using vaginal microbiota analysis
Official title: Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
Run by University Hospital, Clermont-Ferrand · NCT06265740 · Data updated 2026-11-12
This study is testing if analyzing the bacteria in the vagina can help predict premature births in pregnant women who are at risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Status | Recruiting |
| Started | March 29, 2024 |
| Main results expected | November 2025 |
| Study ends | November 2025 |
| Registry record updated | February 12, 2025 |
| Trial ID | NCT06265740 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women admitted to the maternity ward with signs of preterm birth or premature rupture of membranes.
✕Probably not a fit
Patients who have received antibiotic therapy in the two weeks prior to admission may not benefit from this study due to potential alterations in vaginal microbiota.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to identify vaginal microbiota signatures that may predict premature birth in pregnant women at risk. It involves a longitudinal follow-up of participants, where biological samples are collected and analyzed using the RiboTaxa algorithm and neural network learning. The study focuses on women admitted to the maternity ward with signs of preterm birth or premature rupture of membranes, assessing the correlation between microbiota profiles and the occurrence of premature birth. The ultimate goal is to establish a reliable method for early diagnosis of preterm birth.
Why it matters
Potential benefit: If successful, this study could provide a novel diagnostic tool for predicting premature births, potentially improving outcomes for at-risk pregnancies.
How similar studies have gone: While the approach of using vaginal microbiota for predicting preterm birth is innovative, similar studies have shown promise in identifying microbiota signatures related to various health conditions.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CHU de Clermont-Ferrand
Clermont-Ferrand, France Recruiting
Study contacts
- Principal investigator: Denis Gallot — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.