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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 92110
        • Hospital Beaujon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • normal single pregnancy in a healthy volunteer

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
establish a relationship between maternal urinary iodine and thyroid measurements of fetal
Time Frame: final time frame at the end of the study
final time frame at the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dominique LUTON, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

May 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Foetus iodine Status

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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