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<p>During pregnancy, women are in hypercoagulable status, predisposing them to thromboembolic disorders and biomarkers can be used for management of thromboembolism during prenatal care. This study aimed to explore changes and association factors of four coagulation biomarkers — thrombin-antithrombin complex (TAT), plasmin-α2-plasmin inhibitor complex (PIC), tissue plasminogen activator/plasminogen activator inhibitor-1 complex (tPAI-C), and soluble thrombomodulin (TM), during pregnancy and establish their reference intervals in pregnant women. We enrolled 329 healthy pregnant women undergoing prenatal care in Obstetrics and Gynecology Hospital of Fudan University from November 2024 to June 2025. We quantified the levels of these coagulation biomarkers using automated fluorescence immunoassays, and found TAT, TM and tPAI-C increased across three trimesters while PIC decreased. Trimester-specific reference intervals were established following the CLSI EP28-A3c guideline. Multiple linear regression showed that gestational week was a significant influencing factor for all the four biomarkers, while current BMI influenced TAT negatively and diastolic blood pressure influenced tPAI-C positively. No significant association of age, gravidity and parity with these biomarkers was found. This study confirms the progressive hypercoagulable state during pregnancy and established the trimester specific reference intervals of TAT, PIC, TM and tPAI-C using a fluorescence immunoassay platform. The novel finding of associations with BMI and blood pressure warrants further investigation. These biomarkers and their reference intervals may assist in distinguishing between physiological changes and pathological coagulation-fibrinolysis disorders in prenatal care.</p>

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Trimester-specific reference intervals for coagulation biomarkers (TAT, PIC, TM, tPAI-C) and their clinical associations in healthy Chinese pregnant women

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月9日

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  • Fei Ji,
  • Beibei Qian,
  • Jiaying Tao,
  • Ying Zhang,
  • Peimin Mao

摘要

During pregnancy, women are in hypercoagulable status, predisposing them to thromboembolic disorders and biomarkers can be used for management of thromboembolism during prenatal care. This study aimed to explore changes and association factors of four coagulation biomarkers — thrombin-antithrombin complex (TAT), plasmin-α2-plasmin inhibitor complex (PIC), tissue plasminogen activator/plasminogen activator inhibitor-1 complex (tPAI-C), and soluble thrombomodulin (TM), during pregnancy and establish their reference intervals in pregnant women. We enrolled 329 healthy pregnant women undergoing prenatal care in Obstetrics and Gynecology Hospital of Fudan University from November 2024 to June 2025. We quantified the levels of these coagulation biomarkers using automated fluorescence immunoassays, and found TAT, TM and tPAI-C increased across three trimesters while PIC decreased. Trimester-specific reference intervals were established following the CLSI EP28-A3c guideline. Multiple linear regression showed that gestational week was a significant influencing factor for all the four biomarkers, while current BMI influenced TAT negatively and diastolic blood pressure influenced tPAI-C positively. No significant association of age, gravidity and parity with these biomarkers was found. This study confirms the progressive hypercoagulable state during pregnancy and established the trimester specific reference intervals of TAT, PIC, TM and tPAI-C using a fluorescence immunoassay platform. The novel finding of associations with BMI and blood pressure warrants further investigation. These biomarkers and their reference intervals may assist in distinguishing between physiological changes and pathological coagulation-fibrinolysis disorders in prenatal care.