Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00162539
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : July 26, 2012
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Deficiency Disease Other: echography Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension
Study Start Date : October 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

Intervention Details:
    Other: echography
    Correlation of neonatal thyroid volume with maternal iodine deficiency

Primary Outcome Measures :
  1. establish a relationship between maternal urinary iodine and thyroid measurements of fetal [ Time Frame: final time frame at the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • normal single pregnancy in a healthy volunteer

Exclusion Criteria:

  • any associated disease
  • pertubation of thyroid status at 12 GA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162539

Hospital Beaujon
Paris, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Dominique LUTON Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christiophe Aucan, Department Clinical Research of Develeppement Identifier: NCT00162539     History of Changes
Other Study ID Numbers: Foetus iodine Status
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: May 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
foetal thyroid mensuration

Additional relevant MeSH terms:
Deficiency Diseases
Nutrition Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs