Hashimoto DiseaseNCT04613323
Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy
An observational study of Hashimoto Disease and Pregnancy Related, run by Centro Diagnostico Priamar.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hashimoto Disease, Pregnancy Related, Thyroid Dysfunction
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with Hashimoto's thyroidis or/and gloiter
Who may be able to join
- Adult HT pregnant women and adult pregnant women with nodular goiter with or whiteout previous known hypothyroidism.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy: Real-word Experience in a Secondary Endocrine Centre in Italy
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.
Read the 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
- the adherence to clinical and biochemical endocrine evaluations before conception
- the use (correct/un-correct) of L-T4 intervention and its monitoring
- 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
- the clinical and biochemical endocrine evaluation 1-2 months after delivery
- the outcome of pregnancy
- the e-mail up-to-date survey on current of off-springs health
- Conditions
- Hashimoto Disease, Pregnancy Related, Thyroid Dysfunction
- Medical subject headings
- Hashimoto Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of thyroid function in pregnancy
Thyroid hormones and TSH
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hashimoto DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Diagnostico Priamar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Giusti, Centro Diagnostico Priamar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613323
- Sponsor's protocol ID
- Priamar001
- Status last verified
- Nov 2020
- First submitted
- 14 Jul 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy: Real-word Experience in a Secondary Endocrine Centre in Italy
- ClinicalTrials.gov ID
- NCT04613323
- Acronym / sponsor ID
- Priamar001
- Conditions
- Hashimoto Disease, Pregnancy Related, Thyroid Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Diagnostico PriamarUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- the adherence to clinical and biochemical endocrine evaluations before conception
- the use (correct/un-correct) of L-T4 intervention and its monitoring
- 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
- the clinical and biochemical endocrine evaluation 1-2 months after delivery
- the outcome of pregnancy
- the e-mail up-to-date survey on current of off-springs health
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Hashimoto's thyroidis or/and gloiter
Key inclusion criteria (1 listed)
- Adult HT pregnant women and adult pregnant women with nodular goiter with or whiteout previous known hypothyroidism.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Control of thyroid function in pregnancy
Time frame: Through study completion, an average of 1 year
Thyroid hormones and TSH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Hashimoto Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 3
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
Thyroid Eye Disease, TED, Graves Orbitopathy
Not yet recruiting
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
Thyroid Autoimmune Disease, Hashimoto's Thyroiditis
Not yet recruitingObservational study
Role of Total Thyroidectomy in Relieving Local Symptoms in Hashimoto's Thyroiditis
Hashimoto Thyroiditis, Goiter
Active, not recruiting
Gluten Free Diet in Hashimoto's Hypothyroidism
Hypothyroidism, Hashimoto Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hashimoto Disease and Pregnancy Related, run by Centro Diagnostico Priamar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Giusti, MD (39 3391753444, omsv1416@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of thyroid function in pregnancy (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.