Clinical trial NCT00379535: Preventing Lack of Iodine During Pregnancy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pregnancy
Keywords: pregnancy , lack of iodine
lack of iodine during pregnancy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2006-09-22
Enrollment: 374
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 "

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence of hypothyroxinemia and hypothyroidism during pregnancy
timeFrame: 9 months max
measure: Change in the functional thyroid parameters of mother during iodine treatment
timeFrame: 2 years
measure: Comparison of the psychometric development of children , for woman with and without treatment
timeFrame: 6, 12, and 24 months
measure: Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Endocrinology - University Hospital
Study officials:
affiliation: CHU Toulouse
name: CARON PHILIPPE, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU LILLE
name: WEMEAU Jean-Louis, Pr
role: STUDY_CHAIR
affiliation: CHU Timone MARSEILLE
name: NICCOLI-SIRE Patricia, Pr
role: STUDY_CHAIR
affiliation: CHU NICE
name: BRUCKER-DAVIS Francoise, Dr
role: STUDY_CHAIR
References:
citation: Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Ressigeac P, Vertongen F, Grange V. Urinary iodine excretion during normal pregnancy in healthy women living in the southwest of France: correlation with maternal thyroid parameters. Thyroid. 1997 Oct;7(5):749-54. doi: 10.1089/thy.1997.7.749.
citation: Caron Ph, D Glinoer La fonction thyroïdienne au cours de la grossesse La Thyroïde. De la physiologie cellulaire aux dysfonctionnements. Des concepts à la pratique. Ed Expansion Scientifique - Paris, 2001, 495-500.