ClinicalTrials.gg
Status unknownNCT04613323Updated Aug 3, 2021

Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy

An observational study in Hashimoto Disease, Pregnancy Related and Thyroid Dysfunction, sponsored by Centro Diagnostico Priamar. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by Centro Diagnostico Priamar · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
Female
01

Study 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.

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

  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
02

Conditions studied

  • Hashimoto Disease
  • Pregnancy Related
  • Thyroid Dysfunction

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03

In context

Hashimoto Disease

53 studies on the registry are indexed under Hashimoto Disease; 13 are open to participants now.

This study's planned enrollment of 100 is below the median of 112 across 22 observational studies indexed under Hashimoto Disease.

Browse Hashimoto Disease studies →

Lead sponsor

This is the only study on the registry with Centro Diagnostico Priamar as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with Hashimoto's thyroidis or/and gloiter

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Control of thyroid function in pregnancy

    Thyroid hormones and TSH

    Time frame: Through study completion, an average of 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2022; primary completion for Jul 2022, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2020
First posted
Nov 3, 2020
StartEst.
Jan 1, 2022
Primary completionEst.
Jul 1, 2022
CompletionEst.
Sep 1, 2022
Last update
Aug 3, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04613323
Lead sponsor
Centro Diagnostico Priamar
Responsible party
Massimo Giusti (Associate Professor, Centro Diagnostico Priamar) — Principal investigator
First posted
Nov 3, 2020
Start date
Jan 1, 2022 (estimated)
Primary completion
Jul 1, 2022 (estimated)
Completion
Sep 1, 2022 (estimated)
Last update
Aug 3, 2021

Study contacts

Massimo Giusti, MD
Contact
omsv1416@gmail.com
39 3391753444

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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