Preventing Lack of Iodine During Pregnancy

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.

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 "

Intervention(s) in this Clinical Trial

• Drug: potassium iodide
  • per os
• Drug: placebo
  • per os

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Daily dose of 200 µg of potassium iodide
• Placebo Comparator: 2
  • Daily dose of placebo

Primary Measures

• 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
  • Time Frame: 2 years
    Safety Issue?: Yes

Secondary Measures

• Prevalence of hypothyroxinemia and hypothyroidism during pregnancy
  • Time Frame: 9 months max
    Safety Issue?: No
• Change in the functional thyroid parameters of mother during iodine treatment
  • Time Frame: 2 years
    Safety Issue?: No
• Comparison of the psychometric development of children , for woman with and without treatment
  • Time Frame: 6, 12, and 24 months
    Safety Issue?: Yes
• Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment
  • Time Frame: 3 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University Hospital, Toulouse Other

Overall Clinical Trial Officials and Contacts

CARON PHILIPPE, Pr Principal Investigator CHU Toulouse  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00379535

Study ID Number: 0501101

ClinicalTrials.gov Identifier: NCT00379535

Health Authority: France: Afssaps - French Health Products Safety Agency