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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03176706




Registration number
NCT03176706
Ethics application status
Date submitted
2/06/2017
Date registered
5/06/2017
Date last updated
13/05/2020

Titles & IDs
Public title
Assessment of Dried Blood Spot Thyroglobulin and Urinary Iodine Concentration in Pregnant Women
Scientific title
Assessment of Dried Blood Spot Thyroglobulin in Pregnant Women to Redefine the Range of Median Urinary Iodine Concentration That Indicates Adequate Iodine Intake
Secondary ID [1] 0 0
STRIPE
Universal Trial Number (UTN)
Trial acronym
STRIPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iodine Deficiency 0 0
Pregnancy Related 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - no intervention

Lebanese pregnant women - Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in the Lebanon.

Thai pregnant women - Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Thailand.

South African pregnant women - Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in South Africa.

New Zealand pregnant women - Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in New Zealand.

Swedish Pregnant women - Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Sweden.

Peruvian pregnant women - Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Peru.

Russian pregnant women - Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Russia.


Other interventions: no intervention
this is a completely observational study, NO INTERVENTION
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Urinary iodine concentration and Thyroglobulin concentration in pregnant women.
Timepoint [1] 0 0
June 2018

Eligibility
Key inclusion criteria
1. Generally healthy
2. No major medical illness, no thyroid disease, and taking no chronic medication
3. No use of iodine containing dietary supplements
4. No use of iodine-containing X-ray /CT contrast agent or iodine containing medication within the last year
5. Aged between 18 and 44 at enrollment
6. Singleton pregnancy
7. Non-smoking
8. Residence at study site since 12 months or longer
Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2019
Sample size
Target
Accrual to date
Final
2900
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otago

Funding & Sponsors
Primary sponsor type
Other
Name
Swiss Federal Institute of Technology
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To avoid iodine deficiency and its consequences in pregnant women and their offspring, women should reach a sufficient iodine intake long before conception. To monitor iodine status, median urinary iodine concentration (UIC) is widely used in pregnant women (PW). Thyroglobulin (Tg) us another marker used to assess iodine status . In this study, urine samples as well as dried blood spots will be collected to measure UIC and Tg (as well as other hormones to define thyroid function) in PW. The results shall be used to reassess the threshold which defines iodine status in PW according to UIC.
Trial website
https://clinicaltrials.gov/study/NCT03176706
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03176706