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Clinical Trial Summary

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).


Clinical Trial Description

1. INCLUSION CRITERIA :

- Old from 6 to 9 years included

- Age of gestation between ≥37 and <41 weeks of amenorrhoea

- Born from a mono-foetale pregnancy

- Euthyroïd at the time of the entry in the study

- Provided education for at the elementary school on a level adapted to its age

2. NON INCLUSION CRITERIA :

- Presenting a congenital hypothyroïd or a known thyroid dysfonction at the time of the entry in the study

- Carrier of a chronic pathology (organic or psychological) or malformative severe

- Presenting an antecedent of Deficit of the Attention-Hyperactivity to the 1st degree

3. EXCLUSION CRITERIA :

o Discovered of a thyroid dysfonction at the time of the entry in the study

4. STRATEGIES / PROCEDURES :

Multicentric, comparative study of a troop of child born to hyperthyroïd mothers during pregnancy (children exposed to the maternal hyperthyroïd) and children born to euthyroïd mothers during pregnancy (nonexposed children with the maternal hyperthyroïd).

- 1st part of the study: Retrospective analyze of the files of symptomatic hyperthyroid mothers during pregnancy.

- 2nd part of the study: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. The exposed children (born to hyperthyroïd mothers during pregnancy) will be compared with nonexposed children (born to euthyroïd mothers during pregnancy). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01779817
Study type Interventional
Source University Hospital, Angers
Contact Natacha BOUHOURS-NOUET
Email NaBouhours-Nouet@chu-angers.fr
Status Recruiting
Phase Phase 4
Start date February 2013
Completion date January 2019