The Effect of Thyroid Hormone Levels in Pregnant Women on the Intelligence Quotient (IQ) of Their Children
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Child Development Disorders Pregnancy Subclinical Hypothyroidism |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Prospective |
| 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 |
Show Detailed Description Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00147433 History of Changes |
| Other Study ID Numbers: | R01 HD44111 |
| Study First Received: | September 2, 2005 |
| Last Updated: | March 30, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
free thyroxine pregnancy fetal brain development thyroid stimulating hormone IQ |
Additional relevant MeSH terms:
|
Developmental Disabilities Hypothyroidism Mental Disorders Diagnosed in Childhood |
Mental Disorders Thyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013