Pregnancy Related Clinical Trial
— IodineMinhoOfficial title:
Observational Study on the Impact of Iodine Supplementation on Maternal and Child's Thyroid Hormone Homeostasis and on the Child's Psychomotor Development, in the Portuguese Minho Region (IodineMinho)
Full intellectual capabilities are achieved only if crucial nutrients are present during development. Iodine deficiency is the most common cause of preventable brain harm in infants. Because of its critical need during pregnancy, several countries implemented programs of iodine supplementation in preconception and pregnancy. In 2013, the prevalence of iodine deficiency in Portugal has led health authorities to issue a recommendation for iodine supplementation. This study aims to evaluate the impact of iodine supplementation on maternal and fetal iodine status and thyroid function, obstetric outcomes, quality of breast milk and child psychomotor development. It also intends to evaluate whether the time of iodine supplementation initiation influences all the above-mentioned parameters. The novelty and relevance of this study reside on the number of women/child and on the extent of health parameters that will be evaluated. The information collected will contribute to the detailed characterization of thyroid hormone homeostasis throughout pregnancy and its relationship with iodine supplementation (including time of initiation). The data will provide evidence on whether this iodine supplementation strategy impacted on iodine sufficiency of the mother and the newborns, or if it needs re-evaluation.
Status | Recruiting |
Enrollment | 304 |
Est. completion date | January 10, 2025 |
Est. primary completion date | January 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Women of who intend to become pregnant or are pregnant, able to read, write and provide informed consent Exclusion Criteria: - Women transferred from outside the study health centres during pregnancy and women taking iodine supplementation before recruitment. - Women not intending to deliver at Hospital de Braga. |
Country | Name | City | State |
---|---|---|---|
Portugal | Usf + Carandá | Braga | |
Portugal | Usf Bracara Augusta | Braga | |
Portugal | Usf Braga Norte | Braga | |
Portugal | Usf Do Minho | Braga | |
Portugal | Usf Gualtar | Braga | |
Portugal | Usf Manuel Rocha Peixoto | Braga | |
Portugal | Usf Maxisaude | Braga | |
Portugal | Usf Ruães | Braga | |
Portugal | Usf S. João de Braga | Braga | |
Portugal | Usf S. Lourenço | Braga |
Lead Sponsor | Collaborator |
---|---|
University of Minho | Administração Regional de Saúde do Norte, Portugal, Clinical Academic Center (2CA-Braga), Hospital de Braga, Instituto Nacional de Saúde Dr Ricardo Jorge, Portugal |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho region | Urinary iodine. | At baseline in women recruited for pregnancy follow-up and in women in childbearing age not planning to become pregnant. | |
Primary | Impact of iodine supplementation on maternal serum parameters of thyroid function and urinary iodine in the first trimester of pregnancy | Serum thyroid hormones (TSH, total and free T4, total and free T3, thyroxine-binding globulin, human chorionic gonadotropin, thyroglobulin, anti-thyroglobulin, anti-thyroperoxidase), urinary iodine. | First trimester of pregnancy | |
Primary | Bayley scale assessed psychomotor development at one year of age | Bayley psychomotor development scale | One year of age | |
Secondary | Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization throughout pregnancy | Serum thyroid hormones (TSH, total and free T4, total and free T3, thyroxine-binding globulin, human chorionic gonadotropin, thyroglobulin, anti-thyroglobulin, anti-peroxidase), urinary iodine, thyroid ultrasound. | Serum thyroid hormones and urinary iodine before iodine supplementation (if any), 1st, 2nd, 3rd trimesters of pregnancy, after delivery. Thyroid ultrasound at baseline, 3rd trimester and 3 months after delivery. | |
Secondary | Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization of newborns | Serum thyroid hormones (TSH and eventually total and free thyroxine as retrieved from the neonatal newborn screening) and urinary iodine. | One to 3 days of age (if full term babies), 1 to 3 days and 4th week of age (in premature and low birth weight babies). | |
Secondary | Iodine and energy composition of human milk 3 months after delivery | Iodine and energy composition (total proteins, lipids and carbohydrates). | Three months after delivery | |
Secondary | Fetal heart rate and thyroid volume at age 3 months | Fetal cardiotocography and thyroid ultrasound. | Fetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age. |
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