Premature BirthPREMABIOTENCT06265740
Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
A study testing vaginal swab in people with Premature Birth and Vaginal Flora, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Birth, Vaginal Flora
- What is being tested?
- vaginal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient under guardianship, curatorship or safeguard of justice
- Patient having received antibiotic therapy in the 2 weeks prior to admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre
Denis Gallot
About this study
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).
Read the 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.
- Conditions
- Premature Birth, Vaginal Flora
- Being tested
- vaginal swab
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal swabOther
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.
| Study group | Role | What they receive |
|---|---|---|
| cohort of pregnant women at -risk of preterm delivery | Other | vaginal swab Receives: Other: vaginal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early diagnosis of preterm birth using vaginal microbiota analysis
prematurity yes/no (define by birth <37WG)
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start29 Mar 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Gallot, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265740
- Sponsor's protocol ID
- RBHP 2023 GALLOT (PREMABIOTE)
- Other IDs
- 2023-A02466-39
- Acronym
- PREMABIOTE
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
- ClinicalTrials.gov ID
- NCT06265740
- Acronym / sponsor ID
- PREMABIOTE / RBHP 2023 GALLOT (PREMABIOTE)
- Conditions
- Premature Birth, Vaginal Flora
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort of pregnant women at -risk of preterm delivery | Other | Other: vaginal swabvaginal swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Patient under guardianship, curatorship or safeguard of justice
- Patient having received antibiotic therapy in the 2 weeks prior to admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal swabAny 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. | Other | cohort of pregnant women at -risk of preterm delivery |
Primary outcome
Early diagnosis of preterm birth using vaginal microbiota analysis
Time frame: at birth
prematurity yes/no (define by birth <37WG)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denis Gallot principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal swab in people with Premature Birth and Vaginal Flora, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early diagnosis of preterm birth using vaginal microbiota analysis (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.