Image

Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients with Thyroid Pathology

Recruiting
18 - 45 years of age
Female
Phase N/A

Powered by AI

Overview

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?

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.

Eligibility

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 details

Thyroid Disease Pregnancy

NCT06788821

IRCCS Azienda Ospedaliero-Universitaria di Bologna

31 January 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.