CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
Nice, Alpes-Maritimes, 06001, France
NCT Number: NCT00831402
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Nice, Alpes-Maritimes, 06001, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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)
Time frame: Every 3 months up to the give birth, the day of a give birth, and after three months
Time frame: Every 3 months up to the give birth, the day of a give birth, and after three months
Centre Hospitalier Universitaire de Nice
Other
Assessment of Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07725549
Birth Weight, Body Weight
Purwodadi Grobogan, Central Java, Indonesia
View Trial DetailsNCT02447159
Behavior, Blood-Borne Infections
Eket, Akwa Ibom State, Nigeria
View Trial DetailsNCT07072507
Birth, Birth Memory
Bursa, Turkey (Türkiye)
View Trial DetailsNCT04446611
Acquired Immunodeficiency Syndrome, Antenatal Care
East London, Eastern Cape, South Africa
View Trial Details