Viewing Study NCT00162539



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Study NCT ID: NCT00162539
Status: COMPLETED
Last Update Posted: 2012-07-26
First Post: 2005-09-10

Brief Title: Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

Official Title: Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension
Status: COMPLETED
Status Verified Date: 2005-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Mother with severe Iodine deficiency are more likely to have neonates with further poor mental development In order to select population which could benefit from iodine supplementation ioduria has been tested but cannot be routinely practised Strong background data suggest that iodine status could be antenatally correlated with foetal thyroid volume The aim of that study is to examine correlation between these two parameter in a population of 130 healthy pregnant women
Detailed Description: Iodine is an essential element in thyroid homeostasis particularly in pregnant woman and her fetus Various studies have clearly shown that antenatal thyroid disorders at both the mother and the fetus could cause in extreme situations of neurological consequences

At a broader scale subtle alterations of thyroid hormone balance has been implicated in developmental delays and deviations of the IQ bell curve in newborn infants of mothers with elevated TSH

The clinical implications of these basic data and public health are yet to confirm

It has been clearly established that there is a moderate iodine deficiency in France with a decreasing gradient from west to east In the Ile de France there is a moderate iodine deficiency this has led some teams to propose a systematic supplementation of all women in iodine

One way to target women who really need supplements systematic determination of urinary iodine tongue this assay is reliable but is difficult to implement in an ad hoc practice at the individual level

Our team has expertise in the field of fetal thyroid particularly in its sonographic and reference curves of the perimeter and diameter of the thyroid are now clearly established reliably

Knowing that iodine deficiency is causing a decline in maternal urine iodine with a phenomenon goitrigénèse and biological hypothyroidism and that some studies have shown that neonatal thyroid volumes were higher in iodine deficient mothers We postulate that the measurement of fetal thyroid by our criteria can be correlated with maternal urinary iodine

If this were the case we will have a simple test to identify iodine supplementation in pregnant women

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None