Clinical trial NCT04613323: Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy
Official title: Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy: Real-word Experience in a Secondary Endocrine Centre in Italy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hashimoto Disease
Pregnancy Related
Thyroid Dysfunction
Lead sponsor: Centro Diagnostico Priamar
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Hashimoto's thyroidis or/and gloiter

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Control of thyroid function in pregnancy
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: