Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients With Thyroid Pathology

NCT ID: NCT06788821

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-12

Study Completion Date

2026-03-01

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Thyroid Disease Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low obstetric risk

i.e., pregnancy with a regular course and not complicated by maternal and/or fetal pathology

Description of the trend of major thyroid ultrasound biometric parameters

Intervention Type DIAGNOSTIC_TEST

Use of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes.

Hypertyroidism

Group con participants with hypertyroidism

Description of the trend of major thyroid ultrasound biometric parameters

Intervention Type DIAGNOSTIC_TEST

Use of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes.

Hypothyroidism

Group of participants with hypothyroidism

Description of the trend of major thyroid ultrasound biometric parameters

Intervention Type DIAGNOSTIC_TEST

Use of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes.

Interventions

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Description of the trend of major thyroid ultrasound biometric parameters

Use of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Contro, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Ospedale Santa Chiara - Trento

Trento, Italy, Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Elena Contro, MD

Role: CONTACT

0512143705

Facility Contacts

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Elena Contro, MD

Role: primary

0512143705

Laura Larcher, MD

Role: primary

+390461903198

Other Identifiers

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FETAL THYROID

Identifier Type: -

Identifier Source: org_study_id

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