Preventing Lack of Iodine During Pregnancy

Toulouse University Hospital

Status and phase

Terminated

Phase 3

Conditions

Pregnancy

Treatments

Drug: potassium iodide

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00379535

PHRC

0501101

Details and patient eligibility

About

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.

Full 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 "

Enrollment

374 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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