NCT00147433|Unknown
The Effect of Thyroid Hormone Levels in Pregnant Women on the Intelligence Quotient (IQ) of Their Children
Are IQs Low in Offspring of Euthyroid Women With Low T4?
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Are IQs Low in Offspring of Euthyroid Women With Low T4?
Sponsor study identifier
NIH
observational
5,000
1 country
1
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 2, 2005
Actual (reported)September 7, 2005
Actual (reported)November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Foundation for Blood Research
Scarborough, Maine, 04021, United States
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. doi: 10.1056/NEJM199908193410801.
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. doi: 10.1136/jms.7.3.127.
Wendy Y. Craig, Ph.D.
Foundation for Blood Research
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
November 2008
Date type not reportedEvaluation of Pre-dose and Post-dose Anti-factor Xa Levels With Enoxaparin Use During Pregnancy
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This date has not been verified as actual or estimated.
Last Updated
March 31, 2006
Record last verified: 2005-09
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Source: ClinicalTrials.gov.
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