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Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension

Primary Purpose

Deficiency Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
echography
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deficiency Disease focused on measuring foetal thyroid mensuration

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: normal single pregnancy in a healthy volunteer Exclusion Criteria: any associated disease pertubation of thyroid status at 12 GA

Sites / Locations

  • Hospital Beaujon

Outcomes

Primary Outcome Measures

establish a relationship between maternal urinary iodine and thyroid measurements of fetal

Secondary Outcome Measures

Full Information

First Posted
September 10, 2005
Last Updated
July 25, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00162539
Brief Title
Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension
Official Title
Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deficiency Disease
Keywords
foetal thyroid mensuration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
echography
Intervention Description
Correlation of neonatal thyroid volume with maternal iodine deficiency
Primary Outcome Measure Information:
Title
establish a relationship between maternal urinary iodine and thyroid measurements of fetal
Time Frame
final time frame at the end of the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: normal single pregnancy in a healthy volunteer Exclusion Criteria: any associated disease pertubation of thyroid status at 12 GA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique LUTON
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Beaujon
City
Paris
ZIP/Postal Code
92110
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21359193
Citation
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.
Results Reference
derived

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Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension

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