NCT06788821

Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients With Thyroid Pathology

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 440 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Thyroid Disease Pregnancy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-12
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-01-23
• Last updated: 2025-01-29

Locations

2 sites across 1 country: Italy