Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy
- Conditions
- Hyperthyroid
- Interventions
- Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
- Registration Number
- NCT01779817
- Lead Sponsor
- University Hospital, Angers
- 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 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 252
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. 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. Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
- Primary Outcome Measures
Name Time Method Scores of global development Quotient (WISC-R) within the first 30 days after inclusion of the patient
- Secondary Outcome Measures
Name Time Method Score of the Achenbach Child Behavior Checklist within the first 30 days after inclusion of the patient Score of the conners scale within the first 30 days after inclusion of the patient Score of the Wechsler Intelligence Scale for Children (WISC-IV) within the first 30 days after inclusion of the patient
Trial Locations
- Locations (13)
University Hospital of Amiens
🇫🇷Amiens, France
University Hospital of Lille
🇫🇷Lille, France
University Hospital of Marseille
🇫🇷Marseille, France
Civil Hospices of Lyon
🇫🇷Bron, France
University Hospital of Angers
🇫🇷Angers, France
University Hospital of Kremlin Bicetre
🇫🇷Le Kremlin Bicetre, France
University Hospital of Nantes
🇫🇷Nantes, France
University Hospital of Cochin
🇫🇷Paris, France
Hospital of Saint Antoine
🇫🇷Paris, France
University Hospital of Reims
🇫🇷Reims, France
University Hospital of Strasbourg
🇫🇷Strasbourg, France
University Hospital of Poitiers
🇫🇷Poitiers, France
University Hospital of Toulouse
🇫🇷Toulouse, France