Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation
| Tracking Information | |||||
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| First Received Date ICMJE | January 28, 2009 | ||||
| Last Updated Date | March 23, 2012 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
• 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) [ Time Frame: Every 3 months up to the give birth, the day of a give birth, and after three months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00831402 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 [ Time Frame: Every 3 months up to the give birth, the day of a give birth, and after three months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation | ||||
| Official Title ICMJE | Assessment of Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation | ||||
| Brief Summary | Goals of the study :
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| 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:
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 |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Pregnancy | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 111 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00831402 | ||||
| Other Study ID Numbers ICMJE | 05-PHRC-03 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Centre Hospitalier Universitaire de Nice | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nice | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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