Status:
UNKNOWN
New Diagnostic Approach for Congenital Toxoplasmosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Congenital Toxoplasmosis
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
Caused by Toxoplasma gondii, toxoplasmosis is mostly asymptomatic except in immunocompromised individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the transplacental p...
Detailed Description
Toxoplasmosis is a cosmopolitan parasitosis that affects one third of the world's population. This infection, caused by Toxoplasma gondii, is mostly asymptomatic except in immunocompromised individual...
Eligibility Criteria
Inclusion
- In all cases, pregnant women whose age ≥ 18 years are concerned.
- Seroconversion group: a diagnosis of toxoplasmic seroconversion will be documented by a negative serology in early pregnancy which becomes positive during pregnancy, with the synthesis of specific IgG;
- Positive control group: known and documented positive toxoplasmosis serology;
- Negative control group: known and documented negative serology for toxoplasmosis at 7 months of pregnancy.
Exclusion
- Non-inclusion criteria common to the three groups
- Expected delivery in another maternity that does not participate in the study;
- Positive serology for HIV;
- Contra-indication to additional tubes during the blood sampling corresponding to the usual follow-up of pregnancy (anemia, all other case according to the evaluation of the clinician in charge of the follow-up);
- Absence of social insurance or CMU or AME;
- Vulnerable pregnant woman (under guardianship or curatorship);
- No signature of consent to participate in research.
Key Trial Info
Start Date :
June 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03385499
Start Date
June 21 2018
End Date
December 1 2020
Last Update
September 25 2018
Active Locations (3)
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1
Hopital Louis Mourier
Colombes, France, 92700
2
Hopital Bichat
Paris, France
3
Hopital Cochin
Paris, France