Pregnancy Clinical Trial
Official title:
Are IQs Low in Offspring of Euthyroid Women With Low T4?
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | November 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Foundation for Blood Research | Scarborough | Maine |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Allan WC, Haddow JE, Palomaki GE, Williams JR, Mitchell ML, Hermos RJ, Faix JD, Klein RZ. Maternal thyroid deficiency and pregnancy complications: implications for population screening. J Med Screen. 2000;7(3):127-30. — View Citation
Haddow JE, Palomaki GE, Allan WC, Williams JR, Knight GJ, Gagnon J, O'Heir CE, Mitchell ML, Hermos RJ, Waisbren SE, Faix JD, Klein RZ. Maternal thyroid deficiency during pregnancy and subsequent neuropsychological development of the child. N Engl J Med. 1999 Aug 19;341(8):549-55. — View Citation
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