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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01779817
First received: January 28, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

January 28, 2013
January 28, 2013
February 2013
February 2016   (final data collection date for primary outcome measure)
Scores of global development Quotient (WISC-R) [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Score of the Achenbach Child Behavior Checklist [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ]
  • Score of the conners scale [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ]
  • Score of the Wechsler Intelligence Scale for Children (WISC-IV) [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
  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).
  1. INCLUSION CRITERIA :

    A-For the child born to hyperthyroid mother during pregnancy :

    • 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

    B-For hyperthyroid mother during pregnancy :

    • Hyperthyroïd during pregnancy (transitory gestation hyperthyroid or disease of Basedow)
    • Euthyroïd at the time of the entry in the study

    C-For the child born to euthyroid mother during pregnancy :

    • 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

    D-For euthyroid mother during pregnancy :

    Euthyroïd at the time of the entry in the study

  2. NON INCLUSION CRITERIA :

    A-For the child born to hyperthyroid mother during pregnancy :

    • 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

    B-For hyperthyroid mother during pregnancy :

    • Pathological pregnancy (gravidic arterial hypertension, gravidic toxaemia, pre-eclampsia, gestational diabetes, threat of premature birth requiring hospitalization) apart from the transitory gestation hyperthyroid
    • Having presented a drug-addiction or an alcoholism during pregnancy

    C-For the child born to euthyroid mother during pregnancy :

    • 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

    D-For euthyroid mother during pregnancy:

    • Pathological pregnancy (gravidic arterial hypertension, gravidic toxaemia, pre-eclampsia, diabetes gestationnel, threat of premature birth requiring a hospitalization) and transitory gestation hyperthyroid
    • Having presented a drug-addiction or an alcoholism during pregnancy
    • Having presented signs of thyroid dysfunction lasting pregnancy (according to the standardized questionnaire)
  3. EXCLUSION CRITERIA :

    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:

    • Discovered of a thyroid dysfonction at the time of the entry in the study
    • Carrying anti-TPO antibody 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).
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Hyperthyroid
Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
  • child born to hyperthyroid mother during pregnancy
    Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
    Intervention: Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
  • child born to euthyroid mother during pregnancy
    Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
    Intervention: Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
252
February 2016
February 2016   (final data collection date for primary outcome measure)
  1. 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. Exclusion Criteria:

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

Both
6 Years to 9 Years
Yes
Contact: Natacha BOUHOURS-NOUET NaBouhours-Nouet@chu-angers.fr
France
 
NCT01779817
PHRC 2011-01
No
University Hospital, Angers
University Hospital, Angers
Not Provided
Principal Investigator: Natacha BOUHOURS-NOUET UNIVERSITY HOSPITAL OF ANGERS
University Hospital, Angers
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP