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

Hyperthyroid Clinical Trial

— EDIEMHYPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01779817
• Other study ID #: PHRC 2011-01
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2013
• Est. completion date: January 2019

Study information

• Verified date: June 2018
• Source: University Hospital, Angers
• Contact: Natacha BOUHOURS-NOUET
• Email: NaBouhours-Nouet[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperthyroid
• Hyperthyroidism

Intervention

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

Locations

Country	Name	City	State
France	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 Bicetre
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores of global development Quotient (WISC-R)		within the first 30 days after inclusion of the patient
Secondary	Score of the Achenbach Child Behavior Checklist		within the first 30 days after inclusion of the patient
Secondary	Score of the conners scale		within the first 30 days after inclusion of the patient
Secondary	Score of the Wechsler Intelligence Scale for Children (WISC-IV)		within the first 30 days after inclusion of the patient