Pregnancy Clinical Trial
Official title:
Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years
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.
Status | Terminated |
Enrollment | 374 |
Est. completion date | June 2010 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Endocrinology - University Hospital | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse | Ministry of Health, France |
France,
Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Réssigeac P, Vertongen F, Grangé 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. — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Prevalence of hypothyroxinemia and hypothyroidism during pregnancy | 9 months max | No | |
Secondary | Change in the functional thyroid parameters of mother during iodine treatment | 2 years | No | |
Secondary | Comparison of the psychometric development of children , for woman with and without treatment | 6, 12, and 24 months | Yes | |
Secondary | Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment | 3 months | No |
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