NCT04010708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
485

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2018

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

October 19, 2023

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

August 3, 2018

Last Update Submit

October 18, 2023

Conditions

Iodine Status in PregnancyIodine Deficiency

Outcome Measures

Primary Outcomes (2)

  • 1st trimester urinary iodine concentration

    Median urinary iodine concentration at 1st trimester of gestation

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

  • Rate of compliance to iodine supplementation guideline

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

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

Secondary Outcomes (5)

  • Change in median iodine-to-creatinine ratio

    Up to 31 weeks

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

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

  • Maternal median thyroglobulin

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

  • 1st trimester mean sodium excretion

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

  • 3rd trimester mean sodium excretion

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

Study Arms (1)

IOMUM

Pregnant women

Diagnostic Test: Urinary Iodine Concentration Measurement

Interventions

Urinary Iodine Concentration MeasurementDIAGNOSTIC_TEST

UIC

IOMUM

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant women included
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Portuguese pregnant women

You may qualify if:

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

You may not qualify if:

  • Use of Levothyroxine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine of the University of Porto

Porto, 4200-319, Portugal

Location

Related Publications (1)

  • Matta Coelho C, Guimaraes J, Bracchi I, Xavier Moreira N, Pinheiro C, Ferreira P, Pestana D, Barreiros Mota I, Cortez A, Prucha C, Martins C, Pinto E, Almeida A, Delerue-Matos C, Dias CC, Moreira-Rosario A, Ribeiro de Azevedo LF, Cruz Fernandes V, Ramalho C, Calhau C, Brantsaeter AL, Costa Leite J, Keating E. Noncompliance to iodine supplementation recommendation is a risk factor for iodine insufficiency in Portuguese pregnant women: results from the IoMum cohort. J Endocrinol Invest. 2022 Oct;45(10):1865-1874. doi: 10.1007/s40618-022-01813-7. Epub 2022 May 30.

    PMID: 35635644DERIVED

Study Officials

  • Elisa Keating, PhD

    Center for Health Technology and Services Research

    PRINCIPAL INVESTIGATOR

  • Conceição Calhau, PhD

    Center for Health Technology and Services Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2018

First Posted

July 8, 2019

Study Start

April 17, 2018

Primary Completion

September 30, 2020

Study Completion

February 28, 2021

Last Updated

October 19, 2023

Record last verified: 2019-07

Locations

PT(1)