Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy
NCT ID: NCT01779817
Last Updated: 2018-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
252 participants
INTERVENTIONAL
2013-02-28
2019-01-31
Brief Summary
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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).
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Detailed Description
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* 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
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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.
Interventions
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Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
6 Years
9 Years
ALL
Yes
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Natacha BOUHOURS-NOUET
Role: PRINCIPAL_INVESTIGATOR
UNIVERSITY HOSPITAL OF ANGERS
Locations
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University Hospital of Amiens
Amiens, , France
University Hospital of Angers
Angers, , France
Civil Hospices of Lyon
Bron, , France
University Hospital of Kremlin Bicetre
Le Kremlin-Bicêtre, , France
University Hospital of Lille
Lille, , France
University Hospital of Marseille
Marseille, , France
University Hospital of Nantes
Nantes, , France
Hospital of Saint Antoine
Paris, , France
University Hospital of Cochin
Paris, , France
University Hospital of Poitiers
Poitiers, , France
University Hospital of Reims
Reims, , France
University Hospital of Strasbourg
Strasbourg, , France
University Hospital of Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PHRC 2011-01
Identifier Type: -
Identifier Source: org_study_id
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