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OpenTrials
Completed

NCT Number: NCT04010708

Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation

Data from 2007 regarding iodine status among Portuguese pregnant women indicate this is an iodine deficient population group, with only 16.8% presenting adequate urinary iodine values. This may have serious implications for normal cognitive development of the offspring and a concerning socioeconomic impact. In 2013, concerns by the Portuguese Directorate-General of Health lead to the implementation of a public health policy (nº 011/2013) recommending iodine supplementation during pregnancy. IoMum emerges from this context to monitor and update iodine status in Portuguese pregnant women and to evaluate the effectiveness of the above policy by assessing clinical compliance to iodine supplementation and the impact of iodine supplementation in this vulnerable group. IoMum will update data on iodine nutrition in Portuguese pregnant women, promoting political actions towards the elimination of iodine deficiency and thus to the reduction of nutritional, social and economic inequalities.

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Key information

Conditions

Iodine Status in Pregnancy Iodine Deficiency

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine of the University of Porto

Porto, 4200-319, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women attending the 1st trimester fetal ultrasound scan, from the 10th to the 13th gestational week.

Exclusion criteria

  • Use of Levothyroxine.

Treatment and study plan

Urinary Iodine Concentration Measurement

Diagnostic Test

UIC

Primary outcomes

  1. 1st trimester urinary iodine concentration

    Time frame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)

    Median urinary iodine concentration at 1st trimester of gestation

  2. Rate of compliance to iodine supplementation guideline

    Time frame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)

    Rate of compliance to iodine supplementation guideline at 1st trimester of gestation

Secondary outcomes

  1. Change in median iodine-to-creatinine ratio

    Time frame: Up to 31 weeks

    Change in median iodine-to-creatinine ratio between 1st and 3rd trimesters of gestation

  2. Proportion of pregnant women with insufficient, adequate or excessive iodine intake

    Time frame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)

    Classification of pregnant women by urinary iodine concentration levels according to WHO criteria (insufficient, adequate or excessive iodine intake) at 1st trimester of gestation.

  3. Maternal median thyroglobulin

    Time frame: Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)

    Maternal median thyroglobulin at 3rd trimester of gestation

  4. 1st trimester mean sodium excretion

    Time frame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)

    Mean sodium excretion at 1st trimester of gestation

  5. 3rd trimester mean sodium excretion

    Time frame: Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)

    Mean sodium excretion at 3rd trimester of gestation

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Centro Hospitalar De São João, E.P.E.
  • Centro de Investigação em Tecnologias e Serviços de Saúde
  • Hospital de Braga
  • NOVA Medical School

Registry information

Acronym: IOMUM

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 8, 2019
Registry last updated
Oct 19, 2023

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.

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