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NCT Number: NCT06788821

Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients With Thyroid Pathology

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?

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Description of the trend of major thyroid ultrasound biometric parameters

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Contro, MD

CONTACT

[email protected]

0512143705

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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