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Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00162539
First received: September 10, 2005
Last updated: July 25, 2012
Last verified: May 2005

September 10, 2005
July 25, 2012
October 2005
June 2006   (final data collection date for primary outcome measure)
establish a relationship between maternal urinary iodine and thyroid measurements of fetal [ Time Frame: final time frame at the end of the study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00162539 on ClinicalTrials.gov Archive Site
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Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension
Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Deficiency Disease
Other: echography
Correlation of neonatal thyroid volume with maternal iodine deficiency
Not Provided
Luton D, Alberti C, Vuillard E, Ducarme G, Oury JF, Guibourdenche J. Iodine deficiency in northern Paris area: impact on fetal thyroid mensuration. PLoS One. 2011 Feb 16;6(2):e14707. doi: 10.1371/journal.pone.0014707.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • normal single pregnancy in a healthy volunteer

Exclusion Criteria:

  • any associated disease
  • pertubation of thyroid status at 12 GA
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00162539
Foetus iodine Status
No
Christiophe Aucan, Department Clinical Research of Develeppement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Dominique LUTON Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP