Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients With Thyroid Pathology

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

440 Participants
are divided into 3 treatment groups
Group A: Low obstetric risk1 intervention
Group B: Hypertyroidism1 intervention
Group C: Hypothyroidism1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Between 14 and 37 pregnancy weeks
2

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

Time frame
Between 14 and 37 pregnancy weeks
3

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

Time frame
Between 14 and 37 pregnancy weeks
4

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

Time frame
Between 14 and 37 pregnancy weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.