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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01779817
Acronym
EDIEMHYPER
Enrollment
252
Registered
2013-01-30
Start date
2013-02-28
Completion date
2019-01-31
Last updated
2018-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperthyroid

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).

Interventions

BEHAVIORALAssessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Scores of global development Quotient (WISC-R)within the first 30 days after inclusion of the patient

Secondary

MeasureTime frame
Score of the Achenbach Child Behavior Checklistwithin the first 30 days after inclusion of the patient
Score of the conners scalewithin 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

Countries

France

Contacts

Primary ContactNatacha BOUHOURS-NOUET
NaBouhours-Nouet@chu-angers.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026