Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes

Completed

• Conditions: Gestational Diabetes

• Registration Number: NCT04683211
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief Summary

Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.

Detailed Description

Physiological iodine requirements are increased in pregnant women, from 150 μg / day to 250 μg / day. The iodine intake is assessed by the iodine concentration in the urine, the target of which in pregnant women is ioduria between 150 and 250 μg / l. The general French population is not deficient in iodine according to the national nutrition health study in 2006-2007, with a median ioduria of 136 μg / l (therefore greater than 100 μg / l) for all elderly adults aged 18-74. However, according to French studies, the median ioduria of pregnant women is between 50 and 100 μg / l, which suggests a moderate iodine deficiency. To maintain euthyroidism, the mother must increase her T4 production by 40- 50% (10-150%), which requires an additional iodine intake of 150-250 μg / d The thyroid contains a reserve of iodine, but this is depleted during pregnancy in the absence of supplementation. Our study therefore aims to assess the amount of iodine supplementation prescribed in pregnant women diagnosed with gestational diabetes because this group of patients benefit from early specialized care for their pregnancies.

Study Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-24
• Study Start: 2021-01-05
• Primary Completion: 2021-04-21
• Status Verified: 2021-05
• Study Completion: 2021-05-11
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• pregnant woman with gestational diabetes
• age ≥ 18 years
• subject informed of the study and not having opposed it.

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Exclusion Criteria

• already known pathology of the thyroid

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Iodine supplementation	Day 0	µg/day

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes, France