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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on neuro-cognitive development of children followed up until two years.
374 patients with pregnancy less 12 weeks amenorrhea
Patients randomized in 2 parallel groups (each group with 187 patients)
Follow up during 3 years with :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Daily dose of 200 µg of potassium iodide |
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| 2 | Placebo Comparator | Daily dose of placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| potassium iodide | Drug | per os |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Supplying a daily dose of 200 µg of potassium iodide in comparison with a placebo dose to pregnant woman and evaluate the impact on neuro-cognitive development of children followed up until two years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of hypothyroxinemia and hypothyroidism during pregnancy | 9 months max | |
| Change in the functional thyroid parameters of mother during iodine treatment | 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CARON PHILIPPE, Pr | University Hospital, Toulouse | Principal Investigator |
| WEMEAU Jean-Louis, Pr | CHRU LILLE | Study Chair |
| NICCOLI-SIRE Patricia, Pr | CHU Timone MARSEILLE | Study Chair |
| BRUCKER-DAVIS Francoise, Dr | Centre Hospitalier Universitaire de Nice | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology - University Hospital | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9349578 | Background | Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Ressigeac P, Vertongen F, Grange V. Urinary iodine excretion during normal pregnancy in healthy women living in the southwest of France: correlation with maternal thyroid parameters. Thyroid. 1997 Oct;7(5):749-54. doi: 10.1089/thy.1997.7.749. | |
| Background | Caron Ph, D Glinoer La fonction thyroïdienne au cours de la grossesse La Thyroïde. De la physiologie cellulaire aux dysfonctionnements. Des concepts à la pratique. Ed Expansion Scientifique - Paris, 2001, 495-500. |
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| ID | Term |
|---|---|
| D011193 | Potassium Iodide |
| ID | Term |
|---|---|
| D007454 | Iodides |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D017680 | Potassium Compounds |
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| placebo |
| Drug |
per os |
|
| Comparison of the psychometric development of children , for woman with and without treatment |
| 6, 12, and 24 months |
| Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment | 3 months |