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Search / Trial NCT06265740

Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Feb 12, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how the bacteria in the vagina, known as vaginal microbiota, can help predict premature births in pregnant women who are at risk. The researchers are using a special computer program that analyzes genetic information from these bacteria to see if it can accurately indicate whether a woman might have her baby early. By understanding the vaginal microbiota better, the hope is to improve early diagnosis and care for women facing this serious issue.

To participate in the trial, women must be at least 14 weeks pregnant and admitted to the Clermont-Ferrand University Hospital maternity ward with signs that they might deliver early, such as contractions or changes in the cervix. They should also be willing to provide a vaginal swab for testing and be covered by French social security. Participants can expect to have their vaginal bacteria analyzed over time and will contribute to important research that could help improve the health outcomes for both mothers and their babies. It’s important to note that women who have recently taken antibiotics or are under legal guardianship cannot join this study.

Gender

FEMALE

Eligibility 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

About University Hospital, Clermont Ferrand

The University Hospital of Clermont-Ferrand is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its multidisciplinary approach, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes collaboration among healthcare professionals, researchers, and academic partners. With a strong commitment to improving patient outcomes, the institution actively engages in a wide array of clinical studies, ranging from early-phase trials to large-scale interventions, aimed at addressing critical health challenges and enhancing treatment modalities. Its state-of-the-art facilities and expertise make it a pivotal contributor to clinical research in the region and beyond.

Locations

Clermont Ferrand, , France

Patients applied

0 patients applied

Trial Officials

Denis Gallot

Principal Investigator

University Hospital, Clermont-Ferrand

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported