Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy (EDIEMHYPER)
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ClinicalTrials.gov Identifier: NCT01779817 |
Recruitment Status : Unknown
Verified June 2018 by University Hospital, Angers.
Recruitment status was: Recruiting
First Posted : January 30, 2013
Last Update Posted : June 15, 2018
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MAIN OBJECTIVE :
To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual development of the child from 6 to 9 years
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SECONDARY OBJECTIVES :
- 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.
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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).
Condition or disease | Intervention/treatment | Phase |
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Hyperthyroid | Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. | Phase 4 |
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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
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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
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EXCLUSION CRITERIA :
o Discovered of a thyroid dysfonction at the time of the entry in the study
- 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).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 252 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy |
Study Start Date : | February 2013 |
Estimated Primary Completion Date : | January 2019 |
Estimated Study Completion Date : | January 2019 |

Arm | Intervention/treatment |
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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.
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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.
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Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. |
- Scores of global development Quotient (WISC-R) [ Time Frame: within the first 30 days after inclusion of the patient ]
- 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 ]

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Ages Eligible for Study: | 6 Years to 9 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779817
Contact: Natacha BOUHOURS-NOUET | NaBouhours-Nouet@chu-angers.fr |
France | |
University Hospital of Amiens | Recruiting |
Amiens, France | |
Contact: RACHEL DESAILLOUD Desailloud.Rachel@chu-amiens.fr | |
Principal Investigator: RACHEL DESAILLOUD | |
Sub-Investigator: HELENE Bony-Trifunovic | |
Sub-Investigator: KARINE Braun | |
University Hospital of Angers | Recruiting |
Angers, France, 49000 | |
Contact: Natacha BOUHOURS-NOUET NaBouhours-Nouet@chu-angers.fr | |
Principal Investigator: Frédéric ILLOUZ | |
Sub-Investigator: Régis COUTANT | |
Sub-Investigator: Patrice RODIEN | |
Principal Investigator: Natacha BOUHOURS-NOUET | |
Civil Hospices of Lyon | Recruiting |
Bron, France, 69677 | |
Contact: Claire BOURNAUD claire.bournaud@chu-lyon.fr | |
Principal Investigator: Claire BOURNAUD | |
Principal Investigator: Marc NICOLINO | |
Sub-Investigator: Françoise BORSON-CHAZOT | |
University Hospital of Kremlin Bicetre | Recruiting |
Le Kremlin Bicetre, France, 94275 | |
Contact: Claire BOUVATTIER claire.bouvattier@bct.aphp.fr | |
Principal Investigator: Claire BOUVATTIER | |
Principal Investigator: Philippe CHANSON | |
University Hospital of Lille | Active, not recruiting |
Lille, France | |
University Hospital of Marseille | Active, not recruiting |
Marseille, France | |
University Hospital of Nantes | Recruiting |
Nantes, France, 44093 | |
Contact: Delphine DRUI delphine.drui@chu-nantes.fr | |
Principal Investigator: Delphine DRUI | |
Hospital of Saint Antoine | Recruiting |
Paris, France, 75012 | |
Contact: Sophie CHRISTIN-MAITRE sophie.christin-maitre@sat.aphp.fr | |
Principal Investigator: Sophie CHRISTIN-MAITRE | |
University Hospital of Cochin | Active, not recruiting |
Paris, France, 75014 | |
University Hospital of Poitiers | Recruiting |
Poitiers, France, 86021 | |
Contact: Samy HADJADJ s.hadjadj@chu-poitiers.fr | |
Principal Investigator: Samy HADJADJ | |
Sub-Investigator: Xavier PIGUEL | |
University Hospital of Reims | Active, not recruiting |
Reims, France, 51092 | |
University Hospital of Strasbourg | Active, not recruiting |
Strasbourg, France | |
University Hospital of Toulouse | Active, not recruiting |
Toulouse, France, 31059 |
Principal Investigator: | Natacha BOUHOURS-NOUET | UNIVERSITY HOSPITAL OF ANGERS |
Responsible Party: | University Hospital, Angers |
ClinicalTrials.gov Identifier: | NCT01779817 |
Other Study ID Numbers: |
PHRC 2011-01 |
First Posted: | January 30, 2013 Key Record Dates |
Last Update Posted: | June 15, 2018 |
Last Verified: | June 2018 |
Hyperthyroidism Thyroid Diseases Endocrine System Diseases |