Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota

NCT06265740 | Recruiting

• 2 other identifiers: RBHP 2023 GALLOT (PREMABIOTE)2023-A02466-39
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Premature Birth; Vaginal Flora

Outcome Measures

Primary Outcomes (1)

• Early diagnosis of preterm birth using vaginal microbiota analysis

  prematurity yes/no (define by birth \<37WG)

  at birth

Study Arms (1)

cohort of pregnant women at -risk of preterm delivery

OTHER

vaginal swab

Other: vaginal swab

Interventions

vaginal swab OTHER

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.

cohort of pregnant women at -risk of preterm delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient under guardianship, curatorship or safeguard of justice
• Patient having received antibiotic therapy in the 2 weeks prior to admission

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Denis Gallot

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: March 29, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

FR (1)