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?
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedMarch 31, 2006
September 1, 2005
September 2, 2005
March 30, 2006
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Foundation for Blood Research
Scarborough, Maine, 04021, United States
Related Publications (2)
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.
PMID: 10451459BACKGROUNDAllan 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.
PMID: 11126160BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy Y. Craig, Ph.D.
Foundation for Blood Research
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
February 1, 2004
Study Completion
November 1, 2008
Last Updated
March 31, 2006
Record last verified: 2005-09