Preventing Lack of Iodine During Pregnancy
Summary
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.
Description
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 "
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Pregnancy
Intervention
potassium iodide, placebo
Location
Endocrinology - University Hospital
Toulouse
France
31059
Status
Active, not recruiting
Source
University Hospital, Toulouse
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00379535
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Iodide Peroxidase
A hemeprotein that catalyzes the oxidation of the iodide radical to iodine with the subsequent iodination of many organic compounds, particularly proteins. EC 1.11.1.8.
Potassium Iodide
An inorganic compound that is used as a source of iodine in thyrotoxic crisis and in the preparation of thyrotoxic patients for thyroidectomy. (From Dorland, 27th ed)
Pregnancy Proteins
Proteins produced by organs of the mother or the PLACENTA during PREGNANCY. These proteins may be pregnancy-specific (present only during pregnancy) or pregnancy-associated (present during pregnancy or under other conditions such as hormone therapy or certain malignancies.)
Potassium Isotopes
Stable potassium atoms that have the same atomic number as the element potassium, but differ in atomic weight. K-41 is a stable potassium isotope.
Pregnancy In Diabetics
The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.
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