Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension

NCT ID: NCT00162539

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deficiency Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

foetal thyroid mensuration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

echography

Correlation of neonatal thyroid volume with maternal iodine deficiency

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* normal single pregnancy in a healthy volunteer

Exclusion Criteria

* any associated disease
* pertubation of thyroid status at 12 GA
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department Clinical Research of Develeppement

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dominique LUTON

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Beaujon

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21359193 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Foetus iodine Status

Identifier Type: -

Identifier Source: org_study_id