Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy

NCT04613323 | Unknown

• 1 other identifier: Priamar001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The management of thyroid function in pregnancy has been object of several guidelines in the last years. Normal thyroid function reduces prenatal and post-natal risks and gestational complaints. Trimester specific reference values of thyroid hormones and thyroid stimulating hormone (TSH) are available for selected geographic population but its are not yet are available in our country. Hashimoto's thyroiditis (HT) is the most frequent autoimmune thyroid disease which can induce thyroid dysfunction, mainly sub-clinical hypothyroidism. Due to the large incidence in women HT and its potential link with thyroid dysfunction this disease could be search and monitored before pregnancy. Anyway a strong recommendation is to test TSH levels in all patients seeking pregnancy at risk for thyroid dysfunction for a history or current symptoms/signs of thyroid dysfunction, known positivity od thyroid autoimmunity or goiter, a history of neck radiation, age \>30 years, diabetes mellitus, previous infertility or pregnant loss, morbid obesity, living in area of moderate-severe iodine deficiency or recent administration of drugs/substance interfering with thyroid function.

Conditions

Hashimoto Disease; Pregnancy Related; Thyroid Dysfunction

Outcome Measures

Primary Outcomes (1)

• Control of thyroid function in pregnancy

  Thyroid hormones and TSH

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: adult females in reproductive age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with Hashimoto's thyroidis or/and gloiter

You may qualify if:

• Adult HT pregnant women and adult pregnant women with nodular goiter with or whiteout previous known hypothyroidism.

You may not qualify if:

• significant pre-pregnancy comorbidity including renal failure, severe liver disease, organ transplant, cardiac failure, psychiatric conditions requiring in-patient admission, history of eating disorder.
• unable to have e-mail address
• unavailable written consent
• unable understand Italian language

Sponsors & Collaborators

• Centro Diagnostico Priamar: lead

MeSH Terms

Conditions

Hashimoto Disease

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Massimo Giusti, MD

CONTACT

39 3391753444; omsv1416@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: November 3, 2020
• Study Start: January 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 3, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share