Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy

Sponsor
Centro Diagnostico Priamar (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04613323
Collaborator
(none)
100
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy: Real-word Experience in a Secondary Endocrine Centre in Italy
    Anticipated Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Control of thyroid function in pregnancy [Through study completion, an average of 1 year]

      Thyroid hormones and TSH

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centro Diagnostico Priamar

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Massimo Giusti, Associate Professor, Centro Diagnostico Priamar
    ClinicalTrials.gov Identifier:
    NCT04613323
    Other Study ID Numbers:
    • Priamar001
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2021