Assessment of Dried Blood Spot Thyroglobulin and Urinary Iodine Concentration in Pregnant Women

Pregnancy Related Clinical Trial

— STRIPE  

Official title:

Assessment of Dried Blood Spot Thyroglobulin in Pregnant Women to Redefine the Range of Median Urinary Iodine Concentration That Indicates Adequate Iodine Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176706
• Other study ID #: STRIPE
• Status: Completed
• Start date: August 9, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: May 2020
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2900
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Iodine Deficiency
• Pregnancy Related

Intervention

Other:
• no intervention
this is a completely observational study, NO INTERVENTION

Locations

Country	Name	City	State
New Zealand	University of Otago	Dunedin	Otago

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary iodine concentration and Thyroglobulin concentration in pregnant women.	Analysis of urine and blood samples to find urinary iodine concentration and Thyroglobulin concentration of each participant.	June 2018