Status:
TERMINATED
Preventing Lack of Iodine During Pregnancy
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Pregnancy
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief 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.
Detailed 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 Fol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT00379535
Start Date
December 1 2006
End Date
June 1 2010
Last Update
October 12 2011
Active Locations (1)
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1
Endocrinology - University Hospital
Toulouse, France, 31059