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.
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 "
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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