Hypothyroidism in Pregnancy and Neuropsychological Development in Children

Summary

Thyroid dysfunction, particularly hypothyroidism and thyroid autoimmunity, impacts a significant proportion of pregnant women, affecting 3% and 17% respectively. The management of thyroid-stimulating hormone (TSH) levels is crucial, with subclinical hypothyroidism often defined by a TSH upper reference limit of 4 mU/L, and overt hypothyroidism by TSH levels above 10 mU/L and potentially low free thyroxine (FT4) levels. Levothyroxine (LT4) treatment is strongly advised for TSH levels above 10 mU/L, with the timing of intervention being critical during the first trimester for optimal fetal brain development.

Research shows that untreated maternal hypothyroidism can significantly impact the neuropsychological development of the child, affecting cognitive, verbal, and motor skills. Even subclinical maternal hypothyroidism has been associated with lower IQ and motor scores in children. Early pregnancy intervention is key, as treatment after the first trimester may not improve children's neurocognitive outcomes.

Regarding sensory and linguistic development, evidence is mixed, but recent studies suggest that maternal hypothyroidism can lead to expressive language delays. The Development Quotient (DQ) is used to assess cognitive and motor development in children, with the Griffiths Mental Development Scales II being a common tool.

This study aims to explore the effects of treated maternal hypothyroidism during pregnancy on children's neurodevelopment, focusing on learning and language. It includes 31 women diagnosed with hypothyroidism and a control group of 21 euthyroid women, along with their children. The study emphasizes the importance of early detection and treatment of maternal hypothyroidism for preventing adverse neurodevelopmental outcomes in offspring. Statistical analysis will be conducted using SPSS, with a focus on maternal-fetal outcomes and cognitive-neuropsychological outcomes, highlighting the significance of early intervention.

Conditions

• Thyroid Dysfunction
• Pregnancy Related
• Language Development

Interventions

DIAGNOSTIC_TEST

Griffiths Scale

The Griffiths Mental Development Scales II are key tools for assessing children's psychomotor development from ages 0 to 6, praised for their strong psychometric properties. They evaluate various functional areas through six subscales, combining parental reports and direct observations of the child's behavior. The areas include locomotion, personal-social interaction, learning and language, eye-hand coordination, and performance, excluding the optional practical reasoning section for older children in this study. The Development Quotient (DQ), calculated by comparing mental and chronological ages, indicates developmental progress or delay, with an average score around 100 ± 15.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Principal Investigators

• Alfredo Pontecorvi · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-19

Primary Completion

2024-04-30

Completion

2024-05-31

Countries

• Italy

Study Locations