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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00147433 |
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.
Condition |
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Child Development Disorders Pregnancy Subclinical Hypothyroidism |
Study Type: | Observational |
Study Design: | Natural History, Cross-Sectional, Case Control, Prospective Study |
Official Title: | Are IQs Low in Offspring of Euthyroid Women With Low T4? |
Estimated Enrollment: | 5000 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | November 2008 |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wendy Y. Craig, Ph.D. | 207-883-4131 | wcraig@fbr.org |
Contact: Edward M. Kloza, M.S. | 207-883-4131 | ekloza@fbr.org |
United States, Maine | |
Foundation for Blood Research | Recruiting |
Scarborough, Maine, United States, 04021 | |
Contact: Wendy Y. Craig, Ph.D. 207-883-4131 wcraig@fbr.org | |
Contact: Edward M. Kloza, M.S. 207-883-4131 ekloza@fbr.org | |
Principal Investigator: Wendy Y. Craig, Ph.D. |
Principal Investigator: | Wendy Y. Craig, Ph.D. | Foundation for Blood Research |
Study ID Numbers: | R01 HD44111 |
Study First Received: | September 2, 2005 |
Last Updated: | March 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00147433 |
Health Authority: | United States: Federal Government |
free thyroxine pregnancy fetal brain development thyroid stimulating hormone IQ |
Developmental Disabilities Mental Disorders Mental Disorders Diagnosed in Childhood Endocrine System Diseases |
Hypothyroidism Endocrinopathy Thyroid Diseases |