CClinicalTrials.gg
Status unknownNCT01779817EDIEMHYPERUpdated Jun 15, 2018

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

A Phase 4 interventional study of Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. in Hyperthyroid, sponsored by University Hospital, Angers. Status unknown at 13 sites in France. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-15.

Sponsored by University Hospital, Angers · Phase 4, Interventional, and Other

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
252
Allocation
Non-randomized
Ages
6 Years to 9 Years
Sex
All
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Study 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).
Read the 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).
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Conditions studied

  • Hyperthyroid

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03

In context

Hyperthyroidism

111 studies on the registry are indexed under Hyperthyroidism; 28 are open to participants now.

This study's planned enrollment of 252 is above the median of 60 across 54 interventional studies indexed under Hyperthyroidism.

Browse Hyperthyroidism studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
252 participants (estimated)

Study arms

  • Other
    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.

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

  • Other
    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.

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

Interventions

  • BehavioralAssessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
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What researchers measure

Primary outcomes

  1. Scores of global development Quotient (WISC-R)

    Time frame: within the first 30 days after inclusion of the patient

Secondary outcomes

  1. Score of the Achenbach Child Behavior Checklist

    Time frame: within the first 30 days after inclusion of the patient

  2. Score of the conners scale

    Time frame: within the first 30 days after inclusion of the patient

  3. 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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Study locations

7 of 13 sites recruiting
  • University Hospital of Amiens
    Amiens, France
    • RACHEL DESAILLOUD · Contact · Desailloud.Rachel@chu-amiens.fr
    • RACHEL DESAILLOUD · Principal investigator
    • HELENE Bony-Trifunovic · Sub investigator
    • KARINE Braun · Sub investigator
    Recruiting
  • University Hospital of Angers
    Angers, 49000, France
    • Natacha BOUHOURS-NOUET · Contact · NaBouhours-Nouet@chu-angers.fr
    • Frédéric ILLOUZ · Principal investigator
    • Régis COUTANT · Sub investigator
    • Patrice RODIEN · Sub investigator
    • Natacha BOUHOURS-NOUET · Principal investigator
    Recruiting
  • Civil Hospices of Lyon
    Bron, 69677, France
    • Claire BOURNAUD · Contact · claire.bournaud@chu-lyon.fr
    • Claire BOURNAUD · Principal investigator
    • Marc NICOLINO · Principal investigator
    • Françoise BORSON-CHAZOT · Sub investigator
    Recruiting
  • University Hospital of Kremlin Bicetre
    Le Kremlin Bicetre, 94275, France
    • Claire BOUVATTIER · Contact · claire.bouvattier@bct.aphp.fr
    • Claire BOUVATTIER · Principal investigator
    • Philippe CHANSON · Principal investigator
    Recruiting
  • University Hospital of Lille
    Lille, France
    Active, not recruiting
  • University Hospital of Marseille
    Marseille, France
    Active, not recruiting
  • University Hospital of Nantes
    Nantes, 44093, France
    Recruiting
  • Hospital of Saint Antoine
    Paris, 75012, France
    Recruiting
  • University Hospital of Cochin
    Paris, 75014, France
    Active, not recruiting
  • University Hospital of Poitiers
    Poitiers, 86021, France
    Recruiting
  • University Hospital of Reims
    Reims, 51092, France
    Active, not recruiting
  • University Hospital of Strasbourg
    Strasbourg, France
    Active, not recruiting
  • University Hospital of Toulouse
    Toulouse, 31059, France
    Active, not recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01779817
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jan 30, 2013
Start date
Feb 2013
Primary completion
Jan 2019 (estimated)
Completion
Jan 2019 (estimated)
Last update
Jun 15, 2018

Study contacts

Natacha BOUHOURS-NOUET
Contact
NaBouhours-Nouet@chu-angers.fr
Natacha BOUHOURS-NOUET
principal investigator · UNIVERSITY HOSPITAL OF ANGERS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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