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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 Summary:

  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 durin
    Sponsor: University Hospital, Angers

    Current Primary Outcome: Scores of global development Quotient (WISC-R) [ Time Frame: within the first 30 days after inclusion of the patient ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Score of the Achenbach Child Behavior Checklist [ Time Frame: within the first 30 days after inclusion of the patient ]
    • Score of the conners scale [ Time Frame: within the first 30 days after inclusion of the patient ]
    • Score of the Wechsler Intelligence Scale for Children (WISC-IV) [ Time Frame: within the first 30 days after inclusion of the patient ]


    Original Secondary Outcome: Same as current

    Information By: University Hospital, Angers

    Dates:
    Date Received: January 28, 2013
    Date Started: February 2013
    Date Completion: February 2016
    Last Updated: April 17, 2015
    Last Verified: April 2015