Preventing Lack of Iodine During Pregnancy

Phase 3

Terminated

• Conditions: Pregnancy
• Interventions: Drug: potassium iodide; Drug: placebo

• Registration Number: NCT00379535
• Lead Sponsor: University Hospital, Toulouse

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

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 Timeline

• Study First Submitted: 2006-09-21
• Study First Submitted QC: 2006-09-21
• Study First Posted: 2006-09-22
• Study Start: 2006-12
• Primary Completion: 2008-12
• Study Completion: 2010-06
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 374

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	potassium iodide	Daily dose of 200 µg of potassium iodide
2	placebo	Daily dose of placebo

Primary Outcome Measures

Name	Time	Method
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	2 years

Secondary Outcome Measures

Name	Time	Method
Prevalence of hypothyroxinemia and hypothyroidism during pregnancy	9 months max
Change in the functional thyroid parameters of mother during iodine treatment	2 years
Comparison of the psychometric development of children , for woman with and without treatment	6, 12, and 24 months
Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment	3 months

Trial Locations

Locations (1)

Endocrinology - University Hospital; 🇫🇷 Toulouse, France