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Goals of the study :
Overt maternal hypothyroidism and/or iodine deficiency during pregnancy are linked to mental retardation in their offspring. Iodine deficiency may lead to maternal hypothyroxinemia, and even mild hypothyroidism in predisposed women. Indeed, thyroid hormones are of paramount importance for fetal brain development. During the first trimester of pregnancy, the only thyroid hormones available to the fetus are from maternal origin. Later in pregnancy, fetal thyroid progressively starts producing thyroid hormone, providing that maternal iodine status is adequate (≥200-250 mcg/day). It has been shown recently that mild maternal hypothyroidism may be responsible for discrete neuropsychological impairment in her child, implying a potential benefit for early screening and care during pregnancy. Furthermore, iodine deficiency is extremely common in our area (Brucker-Davis et al 2004). However, there is no official recommendation for screening and prevention, as for gestational diabetes for example.
We propose to study healthy pregnant women, screened before 12 weeks of gestation and without thyroid disease. They will be randomized in 2 groups and will therefore take pregnancy tablets, iodine fortified or not (Oligobs Maxiode -150 mcg/j of iodine, vs Oligobs grossesse), in addition to appropriate nutritional advice. Their longitudinal study will involve:
This public health project rests on our expertise in the care of pregnancies with maternal endocrine and metabolic disease (Hieronimus et al 2003-2005) and on a close collaboration of our Departments within the Pole "Mother-Child", conveniently located at the same hospital. It will allow us to precise iodine deficiency screening and prevention in our population and to structure and optimize the care for women with thyroid disease screened early in pregnancy (opening of a specific clinic), in order to improve maternal and fetal prognosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm without iodized vitamin (VITAMIN OLIGOBS PREGNANCY) | Other | 50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum) |
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| Arm with iodized vitamin | Active Comparator | The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oligobs Maxiode | Dietary Supplement | The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day) |
| Measure | Description | Time Frame |
|---|---|---|
| • Intra individual variation of maternal thyroglobulin between the first trimester and the delivery • And cord blood thyroglobulin With comparison of the 2 groups (control and supplementation with iodine) | Every 3 months up to the give birth, the day of a give birth, and after three months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of control and treated groups for : • Frequence of miscarriage, duration of gestation, birth weight, APGAR, neonatal complications, Maternal thyroid function, Frequency of post partum thyroiditis,Cord blood thyroid function | Every 3 months up to the give birth, the day of a give birth, and after three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Françoise Dr BRUCKER-DAVIS, PH | CHU de Nice - Service d'endocrinologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez | Nice | Alpes-Maritimes | 06001 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26247661 | Result | Brucker-Davis F, Ganier-Chauliac F, Gal J, Panaia-Ferrari P, Pacini P, Fenichel P, Hieronimus S. Neurotoxicant exposure during pregnancy is a confounder for assessment of iodine supplementation on neurodevelopment outcome. Neurotoxicol Teratol. 2015 Sep-Oct;51:45-51. doi: 10.1016/j.ntt.2015.07.009. Epub 2015 Aug 4. |
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| controll group | Dietary Supplement | 50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum) |
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