[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587208":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":77,"studyPopulation":78,"armGroups":79,"interventions":74,"overallOfficials":83,"centralContacts":88,"locations":99,"responsibleParty":113,"collaborators":74,"id":115,"slug":74,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":74,"studyType":128,"phases":74,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":139,"whyStopped":74,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University of Rijeka","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":52},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Frequency of Neutrophils in Peripheral Blood","Frequency of neutrophils will be measured by differential blood count. Unit of Measure: Percent (%)","Within 24 months from enrollment; analysis over a 12-month period.",{"measure":14,"description":15,"timeFrame":12},"Frequency of Monocytes in Peripheral Blood","Monocyte frequency will be measured by flow cytometry and expressed as percentage of monocytes among CD45⁺ leukocytes.\n\nUnit of Measure: Percent (%)",{"measure":17,"description":18,"timeFrame":12},"Frequency of NKT Cells in Peripheral Blood","NKT cell frequency will be measured by flow cytometry and expressed as percentage of NKT cells within CD3⁺ T lymphocytes.\n\nUnit of Measure: Percent (%)",[20,24,27,31,35,39,41,44,47,49],{"measure":21,"description":22,"timeFrame":23},"Expression of HLA-DR on Monocytes","HLA-DR expression on CD14⁺ monocytes will be measured using flow cytometry and expressed as percentage of HLA-DR⁺ monocytes.\n\nUnit of Measure: Percent (%)","Within 24 months from enrollment.",{"measure":25,"description":26,"timeFrame":23},"Expression of CD25 on NKT Cells","CD25 expression on CD3⁺CD56⁺ NKT cells will be measured using flow cytometry and expressed as percentage of CD25⁺ cells.\n\nUnit of Measure: Percent (%)",{"measure":28,"description":29,"timeFrame":30},"Expression of CD69 on NKT Cells","CD69 expression on CD3⁺CD56⁺ NKT cells will be measured using flow cytometry and expressed as percentage of CD69⁺ cells.\n\nUnit of Measure: Percent (%)","Time Frame: Within 24 months from enrollment.",{"measure":32,"description":33,"timeFrame":34},"Serum Concentration of TSH","TSH concentration will be measured using a chemiluminescent immunoassay (CLIA). Unit of Measure: mU\u002FL","Measured at each trimester; analysis completed within 12 months of final collection.",{"measure":36,"description":37,"timeFrame":38},"Serum Concentration of Free T4","Unit of Measure: pmol\u002FL","Measured at each trimester; analysis completed within 12 months.",{"measure":40,"description":37,"timeFrame":38},"Serum Concentration of Free T3",{"measure":42,"description":43,"timeFrame":38},"Serum Concentration of Thyroglobulin (Tg)","Unit of Measure: ng\u002FmL",{"measure":45,"description":46,"timeFrame":38},"Serum Concentration of TPOAb","Unit of Measure: IU\u002FmL",{"measure":48,"description":46,"timeFrame":38},"Serum Concentration of TgAb",{"measure":50,"description":51,"timeFrame":38},"Serum Concentration of antiTSHR","Unit of Measure: IU\u002FL",[53,56,59,63,66,70],{"measure":54,"description":55,"timeFrame":23},"Correlation Between Immune Cell Frequencies and Thyroid Biomarkers","Correlation between neutrophil, monocyte, and NKT cell frequencies and thyroid hormone\u002Fantibody levels.\n\nUnit of Measure: Correlation coefficient (r)",{"measure":57,"description":58,"timeFrame":23},"Correlation Between Activation Marker Expression and Thyroid Biomarkers","Correlation between expression of HLA-DR, CD25, and CD69 and thyroid hormone\u002Fantibody levels.\n\nUnit of Measure: Correlation coefficient (r)",{"measure":60,"description":61,"timeFrame":62},"Gestational Age at Delivery","Unit of Measure: Weeks","Time Frame: At delivery",{"measure":64,"description":65,"timeFrame":62},"Birth Weight","Unit of Measure: Grams",{"measure":67,"description":68,"timeFrame":69},"Preterm Birth Occurrence","Unit of Measure: Yes\u002FNo","At delivery",{"measure":71,"description":72,"timeFrame":23},"Correlation Between Immune Cell Parameters and Pregnancy Outcomes","Correlation between immune cell parameters and pregnancy outcomes such as gestational age, preterm birth, and birth weight.\n\nUnit of Measure: Correlation coefficient (r)",{"allocation":74,"interventionModel":74,"interventionModelDescription":74,"primaryPurpose":74,"observationalModel":75,"timePerspective":76,"maskingInfo":74},null,"COHORT","PROSPECTIVE","Autoimmune thyroid disease (AITD) affects approximately 2-17% of women of reproductive age, and represents the most common endocrine disorder in pregnancy. It includes autoimmune hyperthyroidism and hypothyroidism. Pregnancy has a significant impact on the regulation of thyroid function, and thyroid dysfunction may contribute to adverse pregnancy outcomes and neonatal complications.\n\nEarly detection of thyroid dysfunction during pregnancy is critical for optimal maternal-fetal health. While acquired immunity is a recognized contributor to the development of AITD, increasing attention has been given to the role of innate immunity. Innate immune mechanisms are essential for early immune response initiation and maintaining maternal tolerance toward the fetus, which represents a semi-allogeneic entity. This tolerogenic state is regulated both systemically and locally at the maternal-fetal interface.\n\nThe most relevant innate immune cells include neutrophils, monocytes\u002Fmacrophages, and natural killer T (NKT) cells. Neutrophils participate in immune defense through cytotoxicity, phagocytosis, and cytokine secretion. Their numbers increase during pregnancy, and they play a role in implantation and placental development. Monocytes and decidual macrophages contribute to immune tolerance and placental remodeling. NKT cells, which bridge innate and adaptive immunity, perform immunoregulatory functions and have been observed in increased proportions in the decidua compared to peripheral blood. However, limited data are available regarding their role in pregnancy with thyroid autoimmunity.\n\nThe hypothesis of this study is that the numbers of neutrophils, monocytes and NKT cells and activation state of monocytes and NKT cells change during normal pregnancy and in pregnancy affected by AITD. The primary objective is to analyze differences in the frequency and activation marker expression of these immune cells between the two groups.\n\nPeripheral blood mononuclear cells will be isolated, labeled, and analyzed using flow cytometry.\n\nExpression of HLA-DR on monocytes and CD69 and CD25 on NKT cells will be quantified. In parallel, thyroid function parameters will be measured, including thyrotropin (TSH), free thyroxine (FT4), free triiodothyronine (FT3), thyroglobulin (Tg), and thyroid autoantibodies (TPOAb, TgAb, antiTSHR).\n\nPregnant women will be enrolled prospectively and will undergo blood sampling in each trimester. Ultrasound evaluation of the thyroid gland will be conducted to aid in diagnosis and classification. Participants will be categorized into groups based on thyroid hormone status and autoantibody titers: (1) normal pregnancy and (2) pregnancy with AITD.\n\nThe expected enrollment is 80 pregnant women (40 per group). All analyses will be conducted according to standardized laboratory and immunophenotyping protocols.\n\nStatistical analysis will include group comparisons using t-tests or ANOVA for parametric data and Mann-Whitney or Kruskal-Wallis tests for non-parametric data. Correlation analyses will be conducted using Pearson or Spearman coefficients. A p-value \\\u003C 0.05 will be considered statistically significant.","The planned prospective observational study will include pregnant women referred by primary care clinics in Rijeka and Primorsko-goranska County to the Clinical Department of Nuclear Medicine and the Department of Endocrinology, Diabetes and Metabolic Diseases of the Clinic of Internal Medicine of the Clinical Hospital Center Rijeka for thyroid examination and who have signed an informed consent form.",[80],{"label":81,"type":74,"description":82,"interventionNames":74},"Pregnant women referred for thyroid examination due to suspected thyroid disease","Adult pregnant women referred to the Clinical Department of Nuclear Medicine and the Department of Endocrinology, Diabetes and Metabolic Diseases of the Clinic of Internal Medicine of the Clinical Hospital Center Rijeka for thyroid examination due to suspected or known AITD and who have signed an informed consent form will participate in the study. The following data is collected and analyzed from pregnant women who are included in the examination on the basis of a signed consent form: Age, number of pregnancies, number of abortions, pregnancy outcome (abortion, premature birth, timely birth, delayed birth). The pregnant women included in the study will be tested three times, i.e. in the first, second and third trimester of pregnancy. Depending on the results of the hormone status and the thyroid autoantibody titre, the pregnant women will be divided into two groups: (1) normal pregnancy and (2) pregnant women with autoimmune thyroid disease.",[84],{"name":85,"affiliation":86,"role":87},"Tatjana Bogović Crnčić","Faculty of Medicine University of Rijeka","PRINCIPAL_INVESTIGATOR",[89,95],{"name":90,"role":91,"phone":92,"phoneExt":93,"email":94},"Bogović Crnčić","CONTACT","0038551658365","0038551658370","tatjanabc@uniri.hr",{"name":96,"role":91,"phone":97,"phoneExt":74,"email":98},"Sotošek","0038551651185","vlatkast@uniri.hr",[100],{"facility":101,"status":74,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":74},"Faculty of Medicine University of Rijeka, Clinical Hospital Center Rijeka","Rijeka","Primorsko-goranska County","51000","Croatia","HR",{"type":108,"coordinates":109},"Point",[110,111],14.44241,45.32673,{"lat":111,"lon":110},{"type":87,"investigatorFullName":85,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":74,"oldOrganization":74},"Associate professor, MD, PhD, Head of the Department of Nuclear Medicine at Faculty of Medicine","100587208",false,"NCT06925399","Changes in Natural Immunity in Pregnant Women With Autoimmune Thyroid Disease","Dynamic Changes of Innate Immune Cells in Pregnant Women With Autoimmune Thyroid Disease","CIPAT","Inclusion Criteria: adult healthy pregnant women and pregnant women with autoimmune thyroid disease\n\n* with a single pregnancy\n* older than 18 years\n* who have signed the informed consent form\n\nExclusion Criteria:\n\n* pregnant women who refuse to give informed consent\n* pregnant women under the age of 18\n* pregnant women with malignant diseases\n* pregnant women with thyrotoxicosis or hypothyroidism of a non-autoimmune nature and previous thyroidectomy or ablative therapy with iodine-131\n* pregnant women with an acute or chronic disease that is not an autoimmune thyroid disease","FEMALE","18 Years","45 Years",{"count":126,"type":127},80,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.\n\nThe 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.",[131,132],"Pregnancy","Autoimmune Thyroid Disease",[131,134,135,136,137,138],"Autoimmune thyroid disease","Innate immunity","NKT cells","Monocytes","Neutrophils","NOT_YET_RECRUITING","2025-04-06",{"date":142,"type":143},"2025-04-13","ACTUAL",{"date":145,"type":127},"2025-05-01",{"date":147,"type":127},"2027-05-01",{"name":5,"class":6},1]