Hypothyroidism in Pregnancy and Neuropsychological Development in Children

NCT06272721 | Not Yet Recruiting

• 1 other identifier: 6272
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• total development quotient measured using the Griffiths scale

  Difference in the total Development Quotient (DQ) measured using the Griffiths scale, which evaluates different areas of neurodevelopment, between children born to mothers with overt hypothyroidism (TSH \> 10 mIU/L) and children born to women without overt hypothyroidism. Difference in the total Development Quotient (DQ) measured using the Griffiths scale, which evaluates different areas of neurodevelopment, between children born to mothers with overt hypothyroidism (TSH \> 10 mIU/L) and children born to women without overt hypothyroidism.

  30 minuts

Study Arms (2)

Group 1: Children of women with overt hypothyroidism during pregnancy

OTHER

31 children undergoing neuropsychological testing for clinical practice, having their 31 mothers exhibited overt hypothyroidism during pregnancy.

Diagnostic Test: Griffiths Scale

Group 2: Children of women without overt hypothyroidism during pregnancy

ACTIVE COMPARATOR

21 children undergoing neuropsychological testing outside of clinical practice, as their 21 mothers did not exhibit overt hypothyroidism during pregnancy.

Diagnostic Test: Griffiths Scale

Interventions

Griffiths Scale DIAGNOSTIC_TEST

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.

Group 1: Children of women with overt hypothyroidism during pregnancy; Group 2: Children of women without overt hypothyroidism during pregnancy

Eligibility Criteria

• Age: 2 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women aged above 18 and not beyond 50; Diagnosed with hypothyroidism during pregnancy; TSH values equal to or greater than 10 mU/L during pregnancy; Children aged between 2 and 6 years born to mothers with overt hypothyroidism during pregnancy; Signature of consent.

You may not qualify if:

• Presence of uncontrolled liver, kidney, diabetic, neurological, and psychiatric comorbidities prior to conception; Twin pregnancies; History of alcohol or smoking during pregnancy; History of infertility or assisted conception.
• Women aged above 18 and not beyond 50; Absence of hypothyroidism during pregnancy; Children aged between 2 and 6 years born to mothers without overt hypothyroidism during pregnancy; Signature of consent.
• Presence of uncontrolled liver, kidney, diabetic, neurological, and psychiatric comorbidities prior to conception; Twin pregnancies; History of alcohol or smoking during pregnancy; History of infertility or assisted conception.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Study Officials

• Alfredo Pontecorvi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: February 19, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

IT (1)