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Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation

Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04010708
Acronym
IOMUM
Enrollment
485
Registered
2019-07-08
Start date
2018-04-17
Completion date
2021-02-28
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iodine Deficiency, Iodine Status in Pregnancy

Brief summary

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.

Interventions

DIAGNOSTIC_TESTUrinary Iodine Concentration Measurement

UIC

Sponsors

NOVA Medical School
CollaboratorOTHER
Centro Hospitalar De São João, E.P.E.
CollaboratorOTHER
Hospital de Braga
CollaboratorOTHER
Centro de Investigação em Tecnologias e Serviços de Saúde
CollaboratorOTHER
Universidade do Porto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Use of Levothyroxine.

Design outcomes

Primary

MeasureTime frameDescription
1st trimester urinary iodine concentrationBetween gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)Median urinary iodine concentration at 1st trimester of gestation
Rate of compliance to iodine supplementation guidelineBetween 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

MeasureTime frameDescription
Maternal median thyroglobulinBetween gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)Maternal median thyroglobulin at 3rd trimester of gestation
Change in median iodine-to-creatinine ratioUp to 31 weeksChange in median iodine-to-creatinine ratio between 1st and 3rd trimesters of gestation
3rd trimester mean sodium excretionBetween gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)Mean sodium excretion at 3rd trimester of gestation
1st trimester mean sodium excretionBetween gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)Mean sodium excretion at 1st trimester of gestation
Proportion of pregnant women with insufficient, adequate or excessive iodine intakeBetween 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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026