Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients with Thyroid Pathology

Recruiting

• Conditions: Thyroid Disease Pregnancy

• Registration Number: NCT06788821
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief 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.

Study Timeline

• Study Start: 2024-06-12
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-23
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 440

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal thyroid volume = (π/6) × Longitudinal diameter × Antero-Posterior diameter × Transverse diameter (mm3)	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
Right and left thyroid lobe transverse diameter (mm)	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
Longitudinal diameter right and left thyroid lobe (mm)	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
Antero-posterior diameter right and left thyroid lobe (mm)	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

Trial Locations

Locations (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy

Ospedale Santa Chiara - Trento; 🇮🇹 Trento, Italy