Informations générales (source: ClinicalTrials.gov)
Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy (EDIEMHYPER)
Interventional
Phase 4
University Hospital, Angers (Voir sur ClinicalTrials)
février 2013
janvier 2019
29 juin 2024
1. MAIN OBJECTIVE :
To assess the consequences of a maternal hyperthyroïd during pregnancy on
intellectual development of the child from 6 to 9 years
2. SECONDARY OBJECTIVES :
1. To assess the consequences of a maternal hyperthyroïd during pregnancy on the
capacities of attention, learning process and the degree of hyperactivity of
the child from 6 to 9 years.
2. To study if it exist differences of intellectual development, capacities of
attention, learning process, and degree of hyperactivity in the child from 6 to
9 years, born to hyperthyroid mother during pregnancy, according to:
- the etiology of the maternal hyperthyroïd (transitory gestation
hyperthyroid versus disease of Basedow),
- the use or not of a anti-thyroid treatment,
- the rate of TSH néonatal (measured with the blotter by tracking with J3 at
all the new born ones).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | Claire BOUVATTIER | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | Sophie CHRISTIN-MAITRE | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Civil Hospices of Lyon - 69677 - Bron - France | Claire BOURNAUD | Contact (sur clinicalTrials) | |||
| University Hospital of Amiens - Amiens - France | RACHEL DESAILLOUD | Contact (sur clinicalTrials) | |||
| University Hospital of Angers - 49000 - Angers - France | Natacha BOUHOURS-NOUET | Contact (sur clinicalTrials) | |||
| University Hospital of Lille - Lille - France | Contact (sur clinicalTrials) | ||||
| University Hospital of Nantes - 44093 - Nantes - France | Delphine DRUI | Contact (sur clinicalTrials) | |||
| University Hospital of Poitiers - 86021 - Poitiers - France | Samy HADJADJ | Contact (sur clinicalTrials) | |||
| University Hospital of Reims - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| University Hospital of Marseille - Marseille - France | Contact (sur clinicalTrials) | ||||
| University Hospital of Strasbourg - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| University Hospital of Toulouse - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
A-For the child born to hyperthyroid mother during pregnancy :
oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of
amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry
in the study oProvided education for at the elementary school on a level adapted to
its age
B-For hyperthyroid mother during pregnancy :
oHyperthyroïd during pregnancy (transitory gestation hyperthyroid or disease of
Basedow) oEuthyroïd at the time of the entry in the study
C-For the child born to euthyroid mother during pregnancy :
oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of
amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry
in the study oProvided education for at the elementary school on a level adapted to
its age
D-For euthyroid mother during pregnancy :
Euthyroïd at the time of the entry in the study
2.
A-For the child born to hyperthyroid mother during pregnancy :
oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of
amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry
in the study oProvided education for at the elementary school on a level adapted to
its age
B-For hyperthyroid mother during pregnancy :
oHyperthyroïd during pregnancy (transitory gestation hyperthyroid or disease of
Basedow) oEuthyroïd at the time of the entry in the study
C-For the child born to euthyroid mother during pregnancy :
oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of
amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry
in the study oProvided education for at the elementary school on a level adapted to
its age
D-For euthyroid mother during pregnancy :
Euthyroïd at the time of the entry in the study
2.
A-For the child born to hyperthyroid mother during pregnancy :
Discovered of a thyroid dysfonction at the time of the entry in the study
B-For hyperthyroid mother during pregnancy:
Discovered of a thyroid dysfonction at the time of the entry in the study
C-For the child born to euthyroid mother during pregnancy:
Discovered of a thyroid dysfonction at the time of the entry in the study
D-For euthyroid mother during pregnancy:
oDiscovered of a thyroid dysfonction at the time of the entry in the study oCarrying
anti-TPO antibody at the time of the entry in the study