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Maternal- Fetal Infection

NCT03371056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2569

Last updated 2026-04-03

No results posted yet for this study

Summary

The purpose of the protocol is to validate a novel point of care multiplex system to detect and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of infection, from a simple vaginal sample, in order to improve the prevention of perinatal bacterial infections.

Conditions

  • Neonatal Infection

Interventions

BIOLOGICAL

Bacteriological analyses on clinical samples performed with swabs

Bacteriological analyses will be performed to assess the InSPIRe kit

Sponsors & Collaborators

  • Bforcure

    collaborator UNKNOWN

  • BPIfrance

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Institut Cochin

    collaborator OTHER

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Laurent Mandelbrot, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Claire Poyart, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Pierre Yves Ancel, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2023-08-30
Completion
2023-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03371056 on ClinicalTrials.gov