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, Comme le montre la figure n°45, les femmes enceintes sont pré-identifiées dans les maternités au moment de leur suivi prénatal, grâce aux résultats sérologiques déjà réalisés
, Pour les trois groupes, lors de l'accouchement, des prélèvements sanguins seront réalisés afin de récolter du matériel biologique. Pour les cas de séroconversion toxoplasmique, l'accès aux cellules mononucléées des femmes enceintes se fera lors du
,
, Au moment de l'écriture du projet, ce choix a été motivé i/par le nombre d'accouchements recensés dans ces trois maternités en 2014 qui était au nombre de 10 700 (scope Santé, HAS), la dernière mise à jour de 2016 élevant ce chiffre à 10 840 accouchements, ii/par une prévalence globale de 2,2 cas de TC diagnostiqués pour 10 000 naissances en France en 2013, 3 cas en 2015 et 2,4 cas en 2016 (CNR Toxoplasmose), et iii/par un taux de transmission in utero de 30%, nous avons associé trois maternités de l'AP-HP pour cet essai clinique
, Louis Mourier avec l'habilitation à prendre en charge les grossesses pathologiques (scope Santé, HAS), favorisant ainsi un nombre de cas plus important par rapport à la moyenne nationale
, III-2-Déroulement de la mise en place d'une recherche clinique Proposé durant deux années consécutives aux appels à candidature du DHU Risques et
Il s'est très vite imposé de mettre en place une démarche de demande d'autorisation de recherche impliquant un être humain. Cette procédure, aux rouages complexes, est réglementée par l'article L1121-1 du Code de la Santé Publique modifié par l'ordonnance n°2016-800 du 16/11/2016 et le décret n°2016-1537 du 16/11/2016 (loi Jardet) d'application de la loi n°2012-300 du 05/03/2012 relative aux Recherches Impliquant la Personne Humaine (RIPH) (sites cnil et recherche clinique Paris Centre). Ainsi, pour que notre projet soit pris en charge et puisse Remington and Klein's Infectious Diseases of fetus and newborn infant, Current concepts of infections of the fetus and newborn infant p3-23, vol.8, pp.949-1042, 2016. ,
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, Poster présenté lors du 2 ème après-midi des jeunes chercheurs, 2015.
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la fréquence de cette infection chez les femmes enceintes était de 49% en 2012, avec un taux de séroconversion de l'ordre de 1% au cours de la grossesse. C'est à dire que sur un peu plus de la moitié des femmes enceintes qui n'ont pas eu la toxoplasmose, certaines d'entre elles peuvent contracter cette infection et la transmettre à leur futur enfant ,
, Le risque de transmission mère-enfant dépend du stade de la grossesse ; il est moins important en début qu'en fin de grossesse. Par contre, les conséquences cliniques sont plus graves en début (comme un risque de mort in utero ou de malformations congénitales) qu'en fin de grossesse