Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients With Thyroid Pathology

Обзор

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?

Подробное описание

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.

Вмешательства

• Диагностический тест Description of the trend of major thyroid ultrasound biometric parameters
  Use of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes.

Первичные конечные точки

• Fetal thyroid volume = (π/6) × Longitudinal diameter × Antero-Posterior diameter × Transverse diameter (mm3) [Срок оценки: Between 14 and 37 pregnancy weeks]
• Right and left thyroid lobe transverse diameter (mm) [Срок оценки: Between 14 and 37 pregnancy weeks]
• Longitudinal diameter right and left thyroid lobe (mm) [Срок оценки: Between 14 and 37 pregnancy weeks]
• Antero-posterior diameter right and left thyroid lobe (mm) [Срок оценки: Between 14 and 37 pregnancy weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 2 центра

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
• Ospedale Santa Chiara - Trento — Trento

Идентификаторы

NCT: NCT06788821 · FETAL THYROID

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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