Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-31 @ 8:27 PM
Study NCT ID:
NCT00379535
Status:
TERMINATED
Last Update Posted:
2011-10-12
First Post:
2006-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Lack of Iodine During Pregnancy
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 "
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PHRC | None | None | View |