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

NCT03176706 | Completed

• 1 other identifier: STRIPE
• Study Type: observational
• Target: 2,900
• Locations: 1 country
• Sites: 1

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.

Conditions

Iodine Deficiency; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (7)

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

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

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

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

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

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

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

Interventions

no intervention OTHER

this is a completely observational study, NO INTERVENTION

Lebanese pregnant women; New Zealand pregnant women; Peruvian pregnant women; Russian pregnant women; South African pregnant women; Swedish Pregnant women; Thai pregnant women

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Generally healthy
• No major medical illness, no thyroid disease, and taking no chronic medication
• No use of iodine containing dietary supplements
• No use of iodine-containing X-ray /CT contrast agent or iodine containing medication within the last year
• Aged between 18 and 44 at enrollment
• Singleton pregnancy
• Non-smoking
• Residence at study site since 12 months or longer

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

University of Otago

Dunedin, Otago, 9054, New Zealand

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 5, 2017
• Study Start: August 9, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

NZ (1)