Preventing Lack of Iodine During Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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374 patients with pregnancy less 12 weeks amenorrhea Patients randomized in 2 parallel groups (each group with 187 patients) one group with 200 µg of potassium iodide one group with placebo Follow up during 3 years with : a selection visit, an inclusion with randomization before 12 weeks amenorrhea and follow up visit at the 5th month and 8th month of pregnancy, the day of birth, and 6, 12, and 24 months  post partum 

Official Title
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Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: potassium iodide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pregnancy less 12 weeks amenorrhea , with clinically normal pregnancy, unique or twiny Patients who agree to take part in the study and able to sign an Informed Consent Form Exclusion Criteria: Patients receiving a treatment for thyroid affection, or with thyroid pathology Patients with a chronic pathology like insulin dependent diabetes or arterial hypertension Patients with a treatment supplying iodine or having had a gynecologic exam with a iodine solution in the last 30 days Patients taking part in another clinical test or in the last 30 days Patients with depressive antecedent before pregnancy or taking antidepressant treatment Psychiatric troubles that may interfere with the clinical evaluation Patients under special supervision or trusteeship No social security cover

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Daily dose of 200 µg of potassium iodide | Drug: potassium iodide<br>* per os<br>* Other names: Iodence;|
| Placebo Comparator: 2<br>Daily dose of placebo | Drug: placebo<br>* per os<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy , lack of iodine, lack of iodine during pregnancy