Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients With Thyroid Pathology

NCT06788821 | Recruiting

• 1 other identifier: FETAL THYROID
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 2

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?

Conditions

Thyroid Disease Pregnancy

Keywords

fetal thyroid

Outcome Measures

Primary Outcomes (4)

• Fetal thyroid volume = (π/6) × Longitudinal diameter × Antero-Posterior diameter × Transverse diameter (mm3)

  Description of the trend of major thyroid ultrasound biometric parameters in fetuses belonging to women with thyroid disease and women at low obstetrical risk

  Between 14 and 37 pregnancy weeks

• Right and left thyroid lobe transverse diameter (mm)

  Description of the trend of major thyroid ultrasound biometric parameters in fetuses belonging to women with thyroid disease and women at low obstetrical risk

  Between 14 and 37 pregnancy weeks

• Longitudinal diameter right and left thyroid lobe (mm)

  Description of the trend of major thyroid ultrasound biometric parameters in fetuses belonging to women with thyroid disease and women at low obstetrical risk

  Between 14 and 37 pregnancy weeks

• Antero-posterior diameter right and left thyroid lobe (mm)

  Description of the trend of major thyroid ultrasound biometric parameters in fetuses belonging to women with thyroid disease and women at low obstetrical risk

  Between 14 and 37 pregnancy weeks

Study Arms (3)

Low obstetric risk

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

Diagnostic Test: Description of the trend of major thyroid ultrasound biometric parameters

Hypertyroidism

Group con participants with hypertyroidism

Diagnostic Test: Description of the trend of major thyroid ultrasound biometric parameters

Hypothyroidism

Group of participants with hypothyroidism

Diagnostic Test: Description of the trend of major thyroid ultrasound biometric parameters

Interventions

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.

Hypertyroidism; Hypothyroidism; Low obstetric risk

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients from 14 to 37 weeks of pregnancy, with thyroid disease or at low obstetric risk who will undergo obstetric ultrasound at the outpatient clinics of the hospitals where they will deliver.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Ospedale Santa Chiara - Trento

Trento, Italy, Italy

NOT YET RECRUITING

Study Officials

• Elena Contro, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Contro, MD

CONTACT

0512143705; elena.contro@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 23, 2025
• Study Start: June 12, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-10

Locations

IT (2)