Hypothyroidism in Pregnancy and Neuropsychological Development in Children
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Feb 15, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of treated hypothyroidism in pregnant women on their children's development, especially focusing on language and learning skills. Hypothyroidism is a condition where the thyroid gland doesn't produce enough hormones, which is important for many body functions, including brain development in babies. The trial will involve 31 pregnant women with hypothyroidism and a control group of 21 women without the condition. It aims to understand how early treatment during pregnancy can help prevent potential delays in children's cognitive and language skills.
To participate in the study, women aged 18 to 50 who have been diagnosed with hypothyroidism during pregnancy and have children aged 2 to 6 years may be eligible. Women without hypothyroidism and their children can also take part in the study. Participants will be asked to provide consent and will undergo assessments regarding their health and their children's development. This research is important because it highlights how early detection and treatment of thyroid issues in pregnancy can positively influence a child's neurodevelopment, ensuring they grow up healthy and capable.
Gender
ALL
Eligibility criteria
- Inclusion Criteria Group 1:
- • Women aged above 18 and not beyond 50; Diagnosed with hypothyroidism during pregnancy; TSH values equal to or greater than 10 mU/L during pregnancy; Children aged between 2 and 6 years born to mothers with overt hypothyroidism during pregnancy; Signature of consent.
- Exclusion Criteria Group 1:
- • Presence of uncontrolled liver, kidney, diabetic, neurological, and psychiatric comorbidities prior to conception; Twin pregnancies; History of alcohol or smoking during pregnancy; History of infertility or assisted conception.
- Inclusion Criteria Group 2:
- • Women aged above 18 and not beyond 50; Absence of hypothyroidism during pregnancy; Children aged between 2 and 6 years born to mothers without overt hypothyroidism during pregnancy; Signature of consent.
- Exclusion Criteria Group 2:
- • Presence of uncontrolled liver, kidney, diabetic, neurological, and psychiatric comorbidities prior to conception; Twin pregnancies; History of alcohol or smoking during pregnancy; History of infertility or assisted conception.
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
Alfredo Pontecorvi
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported