Clinical Trial

Changes in Natural Immunity in Pregnant Women With Autoimmune Thyroid Disease

Study acronym: CIPAT
Not Yet Recruiting
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Record status
This record was last updated April 13, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Autoimmune thyroid disease (AITD) is the most common endocrine disorder in women of reproductive age, including during pregnancy. It encompasses two clinical conditions: autoimmune hyperthyroidism and hypothyroidism. Pregnancy significantly affects thyroid function regulation, while thyroid dysfunction can influence fertility, pregnancy progression, and the postpartum health. Although the role of acquired immunity in AITD is well understood, recent research increasingly emphasizes innate immunity. Key cells involved in innate immunity include neutrophils, monocytes, and NKT cells. However, limited data exist on their role during pregnancy, especially in women with AITD. This study aims to investigate the dynamic changes in neutrophils, monocytes and NKT cells during pregnancy and compare findings between women with normal pregnancies and those with AITD. The study will analyze the frequency and activation status of these innate immune cells in peripheral blood samples collected during the first, second, and third trimesters. In addition, concentrations of thyrotropin, thyroid hormones, thyroglobulin, and thyroid autoantibodies, will be measured. A thyroid ultrasound will also be performed.
Trial Details
NCT Number NCT06925399
Lead Sponsor University of Rijeka
Conditions Pregnancy, Autoimmune Thyroid Disease
Enrollment 80 participants
Start Date 2025-05-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-13