- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00162539
Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Paris, France, 92110
- Hospital Beaujon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- normal single pregnancy in a healthy volunteer
Exclusion Criteria:
- any associated disease
- pertubation of thyroid status at 12 GA
Study Plan
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
Investigators
- Principal Investigator: Dominique LUTON, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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