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”

Evaluate efficacy of potassium iodide during pregnancy on neuro-cognitive development of children followed up until two years.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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
  • Drug
• Placebo Comparator: 2
  • 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.

Secondary Measures

• prevalence of hypothyroxinemia and hypothyroidism during pregnancy
• change in the functional thyroid parameters of mother during iodine treatment
• comparison of the psychometric development of children at 6, 12, and 24 months, for woman with and without treatment
• quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment

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 of 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 Sponsor: University Hospital, Toulouse

Overall Clinical Trial Officials and Contacts

CARON PHILIPPE, Pr Principal Investigator CHU Toulouse  

Overall Contact: CARON PHILIPPE, Pr 0561322344 caron.p@chu-toulouse.fr

Information obtained from ClinicalTrials.gov on October 10, 2008

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