IOMUM: Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| IOMUM Pregnant women |
Diagnostic Test: Urinary Iodine Concentration Measurement
UIC
|
Outcome Measures
Primary Outcome Measures
- 1st trimester urinary iodine concentration [Between 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 guideline [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
- Change in median iodine-to-creatinine ratio [Up to 31 weeks]
Change in median iodine-to-creatinine ratio between 1st and 3rd trimesters of gestation
- 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)]
Classification of pregnant women by urinary iodine concentration levels according to WHO criteria (insufficient, adequate or excessive iodine intake) at 1st trimester of gestation.
- Maternal median thyroglobulin [Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)]
Maternal median thyroglobulin at 3rd trimester of gestation
- 1st trimester mean sodium excretion [Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)]
Mean sodium excretion at 1st trimester of gestation
- 3rd trimester mean sodium excretion [Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)]
Mean sodium excretion at 3rd trimester of gestation
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Health Technology and Services Research | Porto | Portugal | 4200-319 |
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
- Principal Investigator: Elisa Keating, PhD, Center for Health Technology and Services Research
- Principal Investigator: Conceição Calhau, PhD, Center for Health Technology and Services Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IOMUM