Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota

Premature Birth Clinical Trial

— PREMABIOTE  

Official title:

Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06265740
• Other study ID #: RBHP 2023 GALLOT (PREMABIOTE)
• Secondary ID: 2023-A02466-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: November 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Vaginal Flora

Intervention

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 she 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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early diagnosis of preterm birth using vaginal microbiota analysis	prematurity yes/no (define by birth <37WG)	at birth