Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota (PREMABIOTE)

February 10, 2025 updated by: University Hospital, Clermont-Ferrand

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France
        • Recruiting
        • CHU de Clermont-Ferrand
        • Contact:
          • Lise LACLAUTRE
        • Principal Investigator:
          • Denis Gallot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: cohort of pregnant women at -risk of preterm delivery
vaginal swab
Other: vaginal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early diagnosis of preterm birth using vaginal microbiota analysis
Time Frame: at birth
prematurity yes/no (define by birth <37WG)
at birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Denis GALLOT, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2023 GALLOT (PREMABIOTE)
  • 2023-A02466-39 (Other Identifier: 2023-A02466-39)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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