Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients with Thyroid Pathology

January 28, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

The goal of this observational study is to evaluate the possibility to use prenatal ultrasonography for diagnosis and prognostic guidance in cases of suspected fetal thyroid changes in fetuses belonging to women with thyroid disease and women with low obstetric risk (i.e., pregnancy not complicated by maternal and/or fetal pathology) between 14 and 37 gestational weeks.

The main question it aims to answer is:

Is it possible to diagnose thyroid disease in fetuses early using measurable parameters of the fetal thyroid through ultrasonography?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Current knowledge about fetal thyroid anatomy and the association between ultrasonographic alterations and maternal thyroid disease is not yet comprehensive. A number of observational studies have been conducted describing the possible changes found in fetal thyroid parenchyma in mothers with dysthyroidism. In addition, there are interventional studies that have attempted to modulate anti-thyroid therapy in hyperthyroid mothers depending on the ultrasound changes of the fetal thyroid found. However, to date, the possibility of ultrasound study of the fetal thyroid has not been established, and there are no universally recognized reliable nomograms for the assessment of fetal thyroid biometry.

The present study will provide more information about the possibility to use prenatal ultrasonography for diagnosis and prognostic guidance in cases of suspected fetal thyroid changes. In the latter case, we will be able to more accurately delineate the indication for serious prenatal ultrasound checks, guide counseling with the parental couple, addressing them to possible consultation with pediatric specialist.

Women will be asked to undergo a single ultrasound scan, as per normal clinical practice. With the ultrasound scan it will also be possible to assess parameters that will allow the study of the biometry, morphology and volume of fetal thyroid.

Study Type

Observational

Enrollment (Estimated)

440

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
      • Trento, Italy
        • Not yet recruiting
        • Ospedale Santa Chiara - Trento
        • Contact:
        • Contact:
          • Laura Larcher, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from 14 to 37 weeks of pregnancy, with thyroid disease or at low obstetric risk who will undergo obstetric ultrasound at the outpatient clinics of the hospitals where they will deliver.

Description

Inclusion Criteria:

  • Participants between 14 and 37 gestational weeks, who will be followed for the entire period of pregnancy, up to delivery, at the same enrolling center
  • Obtaining informed consent for participation in the study
  • Maternal age between 18 and 45 years (extremes included)
  • Participants with good understanding of the Italian language

Exclusion Criteria:

  • Smoking participants
  • Patients with BMI>30
  • Absence of correct dating of pregnancy within the first trimester
  • Pathological conditions (e.g., malabsorptive or socioeconomic conditions that may interfere with fetal growth)
  • Twin pregnancy
  • Only for the low obstetric risk group of patients: Fetus with malformative pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low obstetric risk
i.e., pregnancy with a regular course and not complicated by maternal and/or fetal pathology
Diagnostic test: Description of the trend of major thyroid ultrasound biometric parameters
Use of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes.
Hypertyroidism
Group con participants with hypertyroidism
Diagnostic test: Description of the trend of major thyroid ultrasound biometric parameters
Use of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes.
Hypothyroidism
Group of participants with hypothyroidism
Diagnostic test: Description of the trend of major thyroid ultrasound biometric parameters
Use of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal thyroid volume = (π/6) × Longitudinal diameter × Antero-Posterior diameter × Transverse diameter (mm3)
Time Frame: Between 14 and 37 pregnancy weeks
Description of the trend of major thyroid ultrasound biometric parameters in fetuses belonging to women with thyroid disease and women at low obstetrical risk
Between 14 and 37 pregnancy weeks
Right and left thyroid lobe transverse diameter (mm)
Time Frame: Between 14 and 37 pregnancy weeks
Description of the trend of major thyroid ultrasound biometric parameters in fetuses belonging to women with thyroid disease and women at low obstetrical risk
Between 14 and 37 pregnancy weeks
Longitudinal diameter right and left thyroid lobe (mm)
Time Frame: Between 14 and 37 pregnancy weeks
Description of the trend of major thyroid ultrasound biometric parameters in fetuses belonging to women with thyroid disease and women at low obstetrical risk
Between 14 and 37 pregnancy weeks
Antero-posterior diameter right and left thyroid lobe (mm)
Time Frame: Between 14 and 37 pregnancy weeks
Description of the trend of major thyroid ultrasound biometric parameters in fetuses belonging to women with thyroid disease and women at low obstetrical risk
Between 14 and 37 pregnancy weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Elena Contro, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FETAL THYROID

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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