Changes in Natural Immunity in Pregnant Women With Autoimmune Thyroid Disease

NCT06925399 | Not Yet Recruiting

• 1 other identifier: uniri-iskusni-biomed-23-61
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Autoimmune Thyroid Disease

Keywords

Pregnancy; Autoimmune thyroid disease; Innate immunity; NKT cells; Monocytes; Neutrophils

Outcome Measures

Primary Outcomes (3)

• 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.

• Frequency of Monocytes in Peripheral Blood

  Monocyte frequency will be measured by flow cytometry and expressed as percentage of monocytes among CD45⁺ leukocytes. Unit of Measure: Percent (%)

  Within 24 months from enrollment; analysis over a 12-month period.

• 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. Unit of Measure: Percent (%)

  Within 24 months from enrollment; analysis over a 12-month period.

Secondary Outcomes (10)

• Expression of HLA-DR on Monocytes

  Within 24 months from enrollment.

• Expression of CD25 on NKT Cells

  Within 24 months from enrollment.

• Expression of CD69 on NKT Cells

  Time Frame: Within 24 months from enrollment.

• Serum Concentration of TSH

  Measured at each trimester; analysis completed within 12 months of final collection.

• Serum Concentration of Free T4

  Measured at each trimester; analysis completed within 12 months.

Other Outcomes (6)

• Correlation Between Immune Cell Frequencies and Thyroid Biomarkers

  Within 24 months from enrollment.

• Correlation Between Activation Marker Expression and Thyroid Biomarkers

  Within 24 months from enrollment.

• Gestational Age at Delivery

  Time Frame: At delivery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only adult pregnant women are eligible for the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• with a single pregnancy
• older than 18 years
• who have signed the informed consent form

You may not qualify if:

• pregnant women who refuse to give informed consent
• pregnant women under the age of 18
• pregnant women with malignant diseases
• pregnant women with thyrotoxicosis or hypothyroidism of a non-autoimmune nature and previous thyroidectomy or ablative therapy with iodine-131
• pregnant women with an acute or chronic disease that is not an autoimmune thyroid disease

Sponsors & Collaborators

• University of Rijeka: lead

Study Sites (1)

Faculty of Medicine University of Rijeka, Clinical Hospital Center Rijeka

Rijeka, Primorsko-goranska County, 51000, Croatia

Location

Study Officials

• Tatjana Bogović Crnčić

  Faculty of Medicine University of Rijeka

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bogović Crnčić

CONTACT

0038551658365; tatjanabc@uniri.hr

Sotošek

CONTACT

0038551651185; vlatkast@uniri.hr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, PhD, Head of the Department of Nuclear Medicine at Faculty of Medicine

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 13, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: The principal investigator and collaborators involved in the research will have access to the IPD and supporting information. Working versions of the data will be stored during the project on the principal investigator's computer, the project collaborator's laptop, and an external drive to which both the collaborators and the principal investigator will have access. The final version of the data will be made available by the principal investigator through the repository of the Faculty of Medicine in Rijeka, established in the national Dabar system, where publications and other project documents will be stored.

Locations

CR (1)