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Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation (IOMUM)

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ClinicalTrials.gov Identifier: NCT04010708
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
Center for Health Technology and Services Research
NOVA Medical School
Centro Hospitalar De São João, E.P.E.
Hospital de Braga
Information provided by (Responsible Party):
Universidade do Porto

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.

Condition or disease Intervention/treatment
Iodine Status in Pregnancy Iodine Deficiency Diagnostic Test: Urinary Iodine Concentration Measurement

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Group/Cohort Intervention/treatment
IOMUM
Pregnant women
Diagnostic Test: Urinary Iodine Concentration Measurement
UIC




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only pregnant women included
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Portuguese pregnant women
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Use of Levothyroxine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010708


Contacts
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Contact: Elisa Keating, PhD +351 220426650 ext 26650 keating@med.up.pt
Contact: António Soares 225513622 ajasoares@med.up.pt

Locations
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Portugal
Center for Health Technology and Services Research Recruiting
Porto, Portugal, 4200-319
Contact: Elisa Keating    220426650    keating@med.up.pt   
Sponsors and Collaborators
Universidade do Porto
Center for Health Technology and Services Research
NOVA Medical School
Centro Hospitalar De São João, E.P.E.
Hospital de Braga
Investigators
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Principal Investigator: Elisa Keating, PhD Center for Health Technology and Services Research
Principal Investigator: Conceição Calhau, PhD Center for Health Technology and Services Research
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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT04010708    
Other Study ID Numbers: IOMUM
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No