NCT01779817

Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy

Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Accepted

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).

Detailed 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).

Conditions

• Hyperthyroid

Interventions

Type	Name	Description
BEHAVIORAL	Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

Timeline

• Start date: 2013-02-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2013-01-30
• Last updated: 2018-06-15

Locations

13 sites across 1 country: France