Thyroid Disease PregnancyNCT06788821
Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients With Thyroid Pathology
An observational study of Thyroid Disease Pregnancy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Thyroid Disease Pregnancy
- What is being tested?
- Description of the trend of major thyroid ultrasound biometric parameters
- How many people
- 440 participants
- Where
- 2 sitesItaly
- Study dates
- 12 Jun 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Elena Contro, MD, 0512143705, elena.contro@aosp.bo.it
- Not yet recruiting
Ospedale Santa Chiara - Trento
Trento, Italy
Laura Larcher, MD, +390461903198, laura.larcher2@apss.tn.it
Laura Larcher, MD
About this study
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?
Read the 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
- Being tested
- Description of the trend of major thyroid ultrasound biometric parameters
- Keywords
- fetal thyroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of the trend of major thyroid ultrasound biometric parametersDiagnostic test
Use of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes.
| Study group | Role | What they receive |
|---|---|---|
| Low obstetric risk | i.e., pregnancy with a regular course and not complicated by maternal and/or fetal pathology Receives: Diagnostic Test: Description of the trend of major thyroid ultrasound biometric parameters | |
| Hypertyroidism | Group con participants with hypertyroidism Receives: Diagnostic Test: Description of the trend of major thyroid ultrasound biometric parameters | |
| Hypothyroidism | Group of participants with hypothyroidism Receives: Diagnostic Test: Description of the trend of major thyroid ultrasound biometric parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Between 14 and 37 pregnancy weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start12 Jun 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Disease PregnancyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Contro, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788821
- Sponsor's protocol ID
- FETAL THYROID
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients With Thyroid Pathology
- ClinicalTrials.gov ID
- NCT06788821
- Acronym / sponsor ID
- FETAL THYROID
- Conditions
- Thyroid Disease Pregnancy
- Keywords
- fetal thyroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low obstetric risk | – | Diagnostic Test: Description of the trend of major thyroid ultrasound biometric parametersi.e., pregnancy with a regular course and not complicated by maternal and/or fetal pathology |
| Hypertyroidism | – | Diagnostic Test: Description of the trend of major thyroid ultrasound biometric parametersGroup con participants with hypertyroidism |
| Hypothyroidism | – | Diagnostic Test: Description of the trend of major thyroid ultrasound biometric parametersGroup of participants with hypothyroidism |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Description of the trend of major thyroid ultrasound biometric parametersUse of prenatal ultrasonography for diagnosis and prognostic guidance in suspected fetal thyroid changes. | Diagnostic test | Hypertyroidism, Hypothyroidism, Low obstetric risk |
Primary outcome
Fetal thyroid volume = (π/6) × Longitudinal diameter × Antero-Posterior diameter × Transverse diameter (mm3)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Contro, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Disease Pregnancy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Contro, MD (0512143705, elena.contro@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal thyroid volume = (π/6) × Longitudinal diameter × Antero-Posterior diameter × Transverse diameter (mm3) (time frame: Between 14 and 37 pregnancy weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.