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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Iodine Deficiency
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 2900

Contacts and Locations

Study Locations

• New Zealand
  • Otago
    • Dunedin, Otago, New Zealand, 9054
      • University of Otago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy pregnant women aged from 18 to 44 years, living since 12 months or longer in the respective country.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lebanese pregnant women; Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in the Lebanon.	Other: no intervention; this is a completely observational study, NO INTERVENTION
Thai pregnant women; Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Thailand.	Other: no intervention; this is a completely observational study, NO INTERVENTION
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.	Other: no intervention; this is a completely observational study, NO INTERVENTION
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.	Other: no intervention; this is a completely observational study, NO INTERVENTION
Swedish Pregnant women; Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Sweden.	Other: no intervention; this is a completely observational study, NO INTERVENTION
Peruvian pregnant women; Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Peru.	Other: no intervention; this is a completely observational study, NO INTERVENTION
Russian pregnant women; Pregnant women which are suspected to have mild to moderate iodine deficiency but are otherwise health and living in Russia.	Other: no intervention; this is a completely observational study, NO INTERVENTION

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STRIPE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No