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

NCT ID: NCT03176706

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-09

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iodine Deficiency Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Lebanese pregnant women

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

no intervention

Intervention Type OTHER

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.

no intervention

Intervention Type OTHER

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.

no intervention

Intervention Type OTHER

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.

no intervention

Intervention Type OTHER

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.

no intervention

Intervention Type OTHER

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.

no intervention

Intervention Type OTHER

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.

no intervention

Intervention Type OTHER

this is a completely observational study, NO INTERVENTION

Interventions

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no intervention

this is a completely observational study, NO INTERVENTION

Intervention Type OTHER

Eligibility Criteria

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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 Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Otago

Dunedin, Otago, New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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STRIPE

Identifier Type: -

Identifier Source: org_study_id

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