Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation

NCT ID: NCT00831402

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-08-31

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

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm without iodized vitamin (VITAMIN OLIGOBS PREGNANCY)

50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum)

Group Type: OTHER

controll group

Intervention Type: DIETARY_SUPPLEMENT

50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum)

Arm with iodized vitamin

The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day)

Group Type: ACTIVE_COMPARATOR

Oligobs Maxiode

Intervention Type: DIETARY_SUPPLEMENT

The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day)

Interventions

Oligobs Maxiode

The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day)

Intervention Type: DIETARY_SUPPLEMENT

controll group

50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum)

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Françoise Dr BRUCKER-DAVIS, PH

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice - Service d'endocrinologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

Locations

CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

Nice, Alpes-Maritimes, France

Countries

France

Other Identifiers

05-PHRC-03

Identifier Type: -

Identifier Source: org_study_id