Clinical trial NCT04288531: Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region
Official 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Iodine Deficiency
Thyroid
Pregnancy Related
Psychomotor Impairment
Hypothyroidism in Pregnancy
Nutrient Deficiency
Keywords: Iodine
Human milk
Maternal health
Nutritional assessment
Thyroid hormones
Pregnancy
Population health
Congenital hypothyroidism
Psychomotor development
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Saúde Dr Ricardo Jorge, Portugal
name: Clinical Academic Center (2CA-Braga)
name: Hospital de Braga
name: Administração Regional de Saúde do Norte, Portugal
First posted: 2020-02-28
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women from community health centers who intend to become pregnant or become pregnant and intend to delivery in the Hospital de Braga.

Brief summary: 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.

Detailed description: Iodine is essential for intellectual development. Its deficiency, alone, is the most frequent cause of preventable brain harm in infants. Iodine is required to synthesize thyroid hormones, key components of central nervous system development. Because of its relevance in pregnancy, several countries have implemented iodine supplementation programs in preconception, pregnancy and lactation.

Iodine deficiency has been previously shown in women of childbearing age in Portugal. Because of this, since 2013 the National Health Authorities have recommended supplementing iodine (200 ug/day) in preconception, pregnant and lactating women. However, the latest Cochrane review on the subject does not allow to conclude on whether iodine supplementation strategies implemented to date are efficient. Therefore, this study is of great public health interest.

The objectives are to:

* Evaluate whether the new policy of recommending iodine supplementation in preconception, throughout pregnancy and during lactation impacted on the prevalence of iodine deficiency in the Minho region of Portugal when compared to the same population before the recommendation.
* Evaluate whether the time of initiation of iodine supplementation (if any) influences the serum levels of thyroid hormones in the three trimesters of pregnancy.
* Evaluate whether the serum levels of thyroid hormones in the first trimester of pregnancy predict psychomotor development of the newborn at 12 months of age.

To achieve these aims the investigators will follow: i) 304 women longitudinally, before, during the three trimesters of pregnancy (primary care Health Centres), at delivery and three months after delivery, ii) their children at birth, 3 and 12 months of age; ii) perform a detailed evaluation of parameters of thyroid function (mother and child) and of psychomotor development of the newborns.

Investigators expect to provide detailed characterization of thyroid hormone homeostasis before and throughout pregnancy, their relation with iodine supplementation (and its timing of administration, if any) and with thyroid hormone parameters and psychomotor development of the newborn.

With 6 years passed since the beginning of recommendation on iodine supplementation, this is an appropriate time to assess its effectiveness. The high number of samples and parameters to analyze make this a high-power study to support public health policies.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho region
timeFrame: At baseline in women recruited for pregnancy follow-up and in women in childbearing age not planning to become pregnant.
measure: Impact of iodine supplementation on maternal serum parameters of thyroid function and urinary iodine in the first trimester of pregnancy
timeFrame: First trimester of pregnancy
measure: Bayley scale assessed psychomotor development at one year of age
timeFrame: One year of age
Secondary outcomes:
measure: Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization throughout pregnancy
timeFrame: 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.
measure: Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization of newborns
timeFrame: 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).
measure: Iodine and energy composition of human milk 3 months after delivery
timeFrame: Three months after delivery
measure: Fetal heart rate and thyroid volume at age 3 months
timeFrame: Fetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age.
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Usf Maxisaude
city: Braga
country: Portugal
facility: Usf Braga Norte
city: Braga
country: Portugal
facility: Usf Ruães
city: Braga
country: Portugal
facility: Usf S. Lourenço
city: Braga
country: Portugal
facility: Usf Gualtar
city: Braga
country: Portugal
facility: Usf + Carandá
city: Braga
country: Portugal
facility: Usf Manuel Rocha Peixoto
city: Braga
country: Portugal
facility: Usf Bracara Augusta
city: Braga
country: Portugal
facility: Usf Do Minho
city: Braga
country: Portugal
facility: Usf S. João de Braga
Study officials:
affiliation: School of Medicine, University of Minho
name: Joana A Palha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopes-Pereira M, Roque S, Costa P, Quialheiro A, Santos NC, Goios A, Vilarinho L, Correia-Neves M, Palha JA. Impact of iodine supplementation during preconception, pregnancy and lactation on maternal thyroid homeostasis and offspring psychomotor development: protocol of the IodineMinho prospective study. BMC Pregnancy Childbirth. 2020 Nov 13;20(1):693. doi: 10.1186/s12884-020-03376-y.