The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease

Iodine Deficiency in Pregnancy Clinical Trial

Official title:

The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease: a Prospective Registry Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03761602
• Other study ID #: ISCMS
• Status: Not yet recruiting
• Start date: December 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Two hundred and ninety pregnant women with gestational age less than 20 weeks will be recruited in this study. Selenium and iodine conditions, and risk of thyroid disease will be monitored until termination of pregnancy, with pregnancy outcomes recorded.

Description:

The study will recruit 290 pregnant women with gestational age less than 20 weeks. Iodine and selenium condition will be evaluated through dietary recall (on base of Chinese food ingredient information) and biochemical examinations (serum iodine concentrations, urinary iodine concentrations, serum selenium concentrations, etc). The nutritional status of iodine and selenium will be monitored and followed up for all the included subjects throughout the pregnancy. The information of thyroid function and level of anti-TPO and anti-TG will be collected. And all the complications (especially thyroid disease) in pregnancy will also be recorded. All pregnant women will be followed up until the termination of pregnancy, with pregnancy outcomes recorded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 290
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical confirmation of being pregnant.

• Being within less than 20 weeks of gestationa.

Exclusion Criteria:

• Being pregnant but over 20 weeks of gestationa.

• Mentally or psychologically unstable.

Related Conditions & MeSH terms

• Iodine Deficiency in Pregnancy
• Iodine Excess in Pregnancy
• Selenium Deficiency in Pregnancy
• Selenium Excess in Pregnancy
• Thyroid Diseases

Intervention

Other:
• Not applicable (for observational studies)
This study is an observational study. No intervention will be administered for research purposes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rongrong Li

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk of thyroid disease	prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies)	From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
Primary	pregnancy outcomes	prevalence of premature birth, stillbirth and abortion	From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
Secondary	prevalence of other pregnant complications	prevalence of gestational diabetes mellitus, gestational hypertension, dyslipidemia, etc.	From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
Secondary	prevalence of thyroid disease in neonates	prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies,or findings of thyroid nodules) in neonates	From date of birth to 4 weeks after birth