Recruiting

Observational Study

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00147433

Conditions

Child Development Disorders

Pregnancy

Subclinical Hypothyroidism

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study is designed to test the hypothesis that the level of the thyroid hormone thyroxine (specifically, free thyroxine, FT4) circulating in the blood of pregnant women is the key thyroid-related factor to influence early fetal brain development. The investigators will recruit 5000 pregnant women with clinically normal thyroid function (normal thyroid stimulating hormone levels) in the second trimester. After the baby has been born, the investigators will measure FT4 in the second trimester maternal blood sample to identify 100 cases (very low FT4 levels) and 100 matched controls (normal FT4 levels). The children of cases and controls will undergo neurodevelopmental testing at 2 years of age to determine whether IQ differs according to maternal FT4 levels during pregnancy. The potential impact of the study is that if such an effect is found, it might be possible to avoid these adverse developmental consequences in children by designing and testing strategies to identify and treat high risk women.

Conditions

Child Development Disorders

Pregnancy

Subclinical Hypothyroidism

Study ID

NCT00147433

Start date

Feb, 2004

Status verified date

Sep, 2005

Completion date

Nov, 2008

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant female
  • Normal TSH in second trimester
  • Singleton pregnancy
  • Term infant weighing 2500g or more
  • No congenital abnormalities noted on birth record
  • Delivery in Maine at 36 weeks or later

Exclusion Criteria:

  • TSH levels outside normal range in second trimester
  • Pre-existing hypothyroidism, treated
  • More than one fetus
  • Premature and/or low birth weight infant
  • Congenital abnormalities noted on birth record

Study Design

Enrollment

5000 participants

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Wendy Y. Craig, Ph.D.

207-883-4131wcraig@fbr.org

Edward M. Kloza, M.S.

207-883-4131ekloza@fbr.org

Locations

Foundation for Blood Research

Recruiting

Scarborough, Maine, United States, 04021

Contacts

Wendy Y. Craig, Ph.D.

207-883-4131wcraig@fbr.org

Edward M. Kloza, M.S.

207-883-4131ekloza@fbr.org

Principal Investigator:

Wendy Y. Craig, Ph.D.

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Mar 31, 2006

Last verified

Sep, 2005

Keywords

  • free thyroxine
  • pregnancy
  • fetal brain development
  • thyroid stimulating hormone
  • IQ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2006-03-31.