Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy

Pregnancy Related Clinical Trial

Official title:

Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy: Real-word Experience in a Secondary Endocrine Centre in Italy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04613323
• Other study ID #: Priamar001
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2020
• Source: Centro Diagnostico Priamar
• Contact: Massimo Giusti, MD
• Phone: 39 3391753444
• Email: omsv1416[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The aim of the study was to retrospectively evaluate from 2011 (data of publication of the first American Thyroid Association (ATA) guidelines for thyroid dysfunction in pregnancy) to now medical record of the a secondary level endocrine unit to verify the adherence to guidelines in the management of thyroid function in pregnant women with HT.

The investigators search

1. the adherence to clinical and biochemical endocrine evaluations before conception

2. the use (correct/un-correct) of L-T4 intervention and its monitoring

3. the difference in thyroid function control between women with a fix increment of- L-T4 posology (25 mcg/week more for each 2 kg increment in body weight) after the initial L-T4 adjustment or prescription

4. the clinical and biochemical endocrine evaluation 1-2 months after delivery

5. the outcome of pregnancy

6. the e-mail up-to-date survey on current of off-springs health

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. significant pre-pregnancy comorbidity including renal failure, severe liver disease, organ transplant, cardiac failure, psychiatric conditions requiring in-patient admission, history of eating disorder.

2. unable to have e-mail address

3. unavailable written consent

4. unable understand Italian language

Related Conditions & MeSH terms

• Hashimoto Disease
• Pregnancy Related
• Thyroid Diseases
• Thyroid Dysfunction
• Thyroiditis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Diagnostico Priamar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of thyroid function in pregnancy	Thyroid hormones and TSH	Through study completion, an average of 1 year