Informations générales (source: ClinicalTrials.gov)
Lyon Clinical Research Program on Maternal and Congenital Toxoplasmosis Based on the Toxo-Ly Cohort: Risks and Clinical Consequences, Prevention, Diagnosis and Treatment
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 1988
décembre 2025
29 juin 2024
Several decades ago, France has made the choice to implement a national prevention
program for congenital toxoplasmosis. The identification in their first trimester of
pregnancy of all pregnant women who are susceptible to Toxoplasma infection has been
mandatory since 1985. In 1992, the decision was made to extent the program to the monthly
retesting of all women identified as not immune, in an attempt to reduce the number of
severely infected children.
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
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Croix Rousse Hospital - Lyon - France | Martine Wallon | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Confirmation in our laboratory of a maternal infection estimated to have occurred
during pregnancy or during the 12 weeks preceding conception.
- Confirmation in our laboratory of a maternal infection estimated to have occurred
during pregnancy or during the 12 weeks preceding conception.
- maternal :infection that could not be confirmed in our reference laboratory