Clinical trial NCT00831402: Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation
Official title: Assessment of Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: woman
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Goals of the study :

1. To study maternal thyroid function during pregnancy with or without supplementation with pregnancy tablets fortified with iodine
2. To establish reference values of thyroid function at different stages of pregnancy (3 trimesters)
3. To precise screening strategy of iodine deficiency in our population and suggest recommendation for its prevention.

Detailed description: Overt maternal hypothyroidism and/or iodine deficiency during pregnancy are linked to mental retardation in their offspring. Iodine deficiency may lead to maternal hypothyroxinemia, and even mild hypothyroidism in predisposed women. Indeed, thyroid hormones are of paramount importance for fetal brain development. During the first trimester of pregnancy, the only thyroid hormones available to the fetus are from maternal origin. Later in pregnancy, fetal thyroid progressively starts producing thyroid hormone, providing that maternal iodine status is adequate (≥200-250 mcg/day). It has been shown recently that mild maternal hypothyroidism may be responsible for discrete neuropsychological impairment in her child, implying a potential benefit for early screening and care during pregnancy. Furthermore, iodine deficiency is extremely common in our area (Brucker-Davis et al 2004). However, there is no official recommendation for screening and prevention, as for gestational diabetes for example.

We propose to study healthy pregnant women, screened before 12 weeks of gestation and without thyroid disease. They will be randomized in 2 groups and will therefore take pregnancy tablets, iodine fortified or not (Oligobs Maxiode -150 mcg/j of iodine, vs Oligobs grossesse), in addition to appropriate nutritional advice. Their longitudinal study will involve:

1. Evolution of thyroid function parameters in the 2 groups, with comparison of maternal thyroid volumes, maternal thyroid hormones levels and cord blood parameters, including thyroglobulin, during pregnancy and in postpartum.
2. Establishment of reference ranges for thyroid parameters for each trimester of pregnancy.

This public health project rests on our expertise in the care of pregnancies with maternal endocrine and metabolic disease (Hieronimus et al 2003-2005) and on a close collaboration of our Departments within the Pole "Mother-Child", conveniently located at the same hospital. It will allow us to precise iodine deficiency screening and prevention in our population and to structure and optimize the care for women with thyroid disease screened early in pregnancy (opening of a specific clinic), in order to improve maternal and fetal prognosis

Eligibility criteria: Inclusion Criteria:

* All women follow-up in the three months of the pregnancy in the CHU de Nice
* Maternal thyroid function is between and 0.1\<TSH\<2.5 mUI/l, 23\>T4L\>12 pmol/l
* Person over 18
* Signed lit Consent
* Give birth in the CHU of Nice

Exclusion Criteria:

* Allergy known in iodine
* Iodized surcharge defined by an iodurie\> 400 mcg / l
* Catch of ongoing iodized vitamins of pregnancy
* Participation in another research protocol

Primary outcomes:
measure: • Intra individual variation of maternal thyroglobulin between the first trimester and the delivery • And cord blood thyroglobulin With comparison of the 2 groups (control and supplementation with iodine)
timeFrame: Every 3 months up to the give birth, the day of a give birth, and after three months
Secondary outcomes:
measure: Comparison of control and treated groups for : • Frequence of miscarriage, duration of gestation, birth weight, APGAR, neonatal complications, Maternal thyroid function, Frequency of post partum thyroiditis,Cord blood thyroid function
timeFrame: Every 3 months up to the give birth, the day of a give birth, and after three months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - Service d'endocrinologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
name: Françoise Dr BRUCKER-DAVIS, PH
role: PRINCIPAL_INVESTIGATOR
References: