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
About this trial
This is an interventional prevention trial for Deficiency Disease focused on measuring foetal thyroid mensuration
Eligibility Criteria
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
NCT ID
NCT00162539
First Posted
September 10, 2005
Last Updated
July 25, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
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
Learn more about this trial
Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension
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