Status:
UNKNOWN
Maternal- Fetal Infection
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Bforcure
BPIfrance
Conditions:
Neonatal Infection
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Early-onset neonatal sepsis (EOS) is a major global public health challenge. Prevention during pregnancy and delivery, early diagnosis and treatment of perinatal infections are essential to avoid EOS....
Eligibility Criteria
Inclusion
- Pregnant woman,
- Gestational age over 22 SA,
- Patient agreeing to sign informed consent,
- Patient aged at least 18 years old,
- Patient with health insurance,
- Singleton, twin or multiple pregnancy.
Exclusion
- Fetal death or non-viable fetus,
- maternal age under 18,
- Patient unable to express her consent,
- Patient under guardianship.
Key Trial Info
Start Date :
August 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
2600 Patients enrolled
Trial Details
Trial ID
NCT03371056
Start Date
August 28 2018
End Date
December 30 2023
Last Update
September 27 2022
Active Locations (3)
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1
Hopital Louis Mourier
Colombes, France, 92700
2
Hôpital Cochin
Paris, France, 75014
3
Hopital Bichat
Paris, France, 75018