Using ultrasound to assess fetal thyroid in pregnant women with thyroid disease
Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients With Thyroid Pathology
This study is testing whether ultrasound can help check the thyroid health of unborn babies in pregnant women who have thyroid disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 440 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 2 sites (Bologna, Bologna and 1 other locations) |
| Trial ID | NCT06788821 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of using prenatal ultrasonography to diagnose and provide prognostic guidance for suspected fetal thyroid changes in fetuses of women with thyroid disease. The study will involve a single ultrasound scan conducted between 14 and 37 gestational weeks, focusing on measuring parameters related to fetal thyroid biometry, morphology, and volume. By analyzing these parameters, the study seeks to enhance understanding of the relationship between maternal thyroid conditions and fetal thyroid health, potentially leading to improved prenatal care and counseling.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 to 45 with thyroid disease, between 14 and 37 weeks of gestation, and who can provide informed consent.
Not a fit: Patients who are smokers, have a BMI over 30, or have certain pathological conditions that may interfere with fetal growth will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable early diagnosis of fetal thyroid disease, leading to better management and outcomes for affected pregnancies.
How similar studies have performed: While there have been observational studies on fetal thyroid changes in mothers with thyroid disease, this specific approach using ultrasound for early diagnosis is novel and has not been universally established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna, Bologna and 1 other locations
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
- Ospedale Santa Chiara - Trento — Trento, Italy, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Elena Contro, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Elena Contro, MD
- Email: elena.contro@aosp.bo.it
- Phone: 0512143705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.