Lyon Cohort of Maternal and Congenital Toxoplasma Infections
NCT ID: NCT02936921
Last Updated: 2016-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4030 participants
OBSERVATIONAL
1988-01-31
2025-12-31
Brief Summary
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The systematic detection of all maternal and congenital infections has generated many questions from clinicians, biologists, parents and older patients, on the short and long-term prognosis of congenital toxoplasmosis, on the best tests to use to diagnose infections in mothers and children, on the efficacy of existing treatments, and on how to manage patients in the long-term.
The need to answer these many questions has prompted the medical team working within the laboratory and the outpatient department of the Parasitology Department at the Croix-Rousse Hospital in Lyon to implement a clinical research program. It is based on the systematic inclusion in our cohort of all pregnant women whose infection is confirmed, on their follow up, in order to monitor the outcome of pregnancy 2) and on the follow up of their children in order to confirm their infection or to rule it out. All congenitally infected subjects undergo clinical examinations, serological tests and ocular examination at least once a year without age limit.
The following data are prospectively collected in a dedicated database: gestational age at maternal infection and corresponding serological profile; type and dates of maternal treatment; findings of ultrasound tests and amniotic fluid analysis; serological and clinical findings at birth; types and dates of postnatal treatment; postnatal serological profiles; infection status at one year of age; long term clinical (ophthalmologic) et serological findings.
These data have allowed producing original findings on the risk of maternal-foetal transmission according to gestational age at maternal infection, on the long term ophthalmological outcome of congenital toxoplasmosis and to offer guidelines for the diagnosis, treatment and follow-up of maternal and congenital infections.
These efforts are still to be maintained in the future in order
* to further analyse the impact of puberty, pregnancy, or adult co-morbidities on the risk of ophthalmological events
* to increase precision around our risk estimates for materno-foetal transmission,
* to continue innovating in terms of diagnostic strategy to improve tests performances and reduce costs
* to explore new potential clinical outcomes such as neuropsychiatric disorders associated with congenital and postnatal infection
* to determine if infections due to oocysts could have different clinical outcomes than those due to the ingestion of cysts
* to assess the efficacy of treatments for maternal and congenital infections
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pergravidic maternal infections
proven maternal infections: true seroconversions of profiles of recent infections
No interventions assigned to this group
Subjects free of congenital infection
children who whom all tests performed before birth, at birth and after birth confirmed the absence of congenital toxoplasmosis.
No interventions assigned to this group
Congenitally infected subjects
children for whom at least one test performed before birth, at birth or after birth demonstrated a congenital infection.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Croix Rousse Hospital
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Martine Wallon
Role: primary
Related Links
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Related Info
Other Identifiers
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69HCL16_0569
Identifier Type: -
Identifier Source: org_study_id
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