Iodine Status in Pregnant Women in Israel

• Conditions: Iodine-Deficiency; Hypothyroidism
• Interventions: Diagnostic Test: Urine sample for iodine measurement

• Registration Number: NCT03120221
• Lead Sponsor: Clalit Health Services

Brief Summary

Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women. Thus, screening first trimester healthy pregnant women for iodine status is of clinical value for mother and child as iodine deficiency might have implications on thyroid function as well as pregnancy outcomes

Detailed Description

New emerging data suggest pregnant women in Israel are iodine deficient in the first trimester of pregnancy. This is of major concern as first trimester iodine sufficiency is critical for the development of the fetal brain. Our aim is to evaluate iodine consumption in first trimester pregnant women in Israel through dietary questioners, Urinary iodine samples and thyroid functions test assessed through blood samples. All data will be analyzed in a central lab.

Study Timeline

• Study First Submitted: 2017-04-01
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-19
• Study Start: 2017-07-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

First trimester pregnant women with a singleton pregnancy

Exclusion Criteria

1. Women with a known thyroid disease treated or untreated
2. Women who received contrast material in the year previous to the study
3. women with any chronic disease
4. Women who receive chronic medication not including vitamins

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
First trimester pregnant women	Urine sample for iodine measurement	-

Primary Outcome Measures

Name	Time	Method
Evaluation of average iodine consumption in food	1 year	Iodine consumption will be evaluated trough detailed food questionnaires. Data will be quantified and reported in micrograms per day
Evaluation of urinary iodine concentration	1 year	Women will give a spot urine sample for urinary iodine concentration measurement. All data will be analyzed and reported in micrograms/L. Data obtained will be compared to World Health Organization requirements
Thyroid function test measurement	1 year	Thyroid function will be evaluated through blood tests in the first trimester of pregnancy. Data will be analyzed in accordance with local guidelines.

Trial Locations

Locations (2)

Women Health Service; 🇮🇱 Ashdod, Israel

Women Health Center; 🇮🇱 Tel Aviv, Israel