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Background <p>Severe haemorrhage remains a leading cause of maternal mortality worldwide, despite advancements in obstetric care. Although viscoelastic testing is recommended to guide treatment of postpartum haemorrhage, device-specific physiological parameters and reference ranges specific to pregnancy are necessary to enable accurate interpretation of viscoelastic findings in the clinical management of obstetric patients. Evaluation of ClotPro<sup>®</sup>, including comparison with conventional laboratory assays and with non-pregnant individuals, is therefore essential to support its use in obstetric patients.</p> Methods <p>In this prospective study, venous blood samples were obtained from 130 parturient participants before labour and 45 non-pregnant controls. Samples were analysed with conventional laboratory coagulation tests and the ClotPro<sup>®</sup> device. ClotPro<sup>®</sup> parameters and conventional laboratory tests were compared between the parturient population and non-pregnant control group with Student’s t-test or the Mann-Whitney U test, as appropriate. The correlation between selected laboratory and coagulation parameters was assessed with Spearman’s correlation coefficient. Reference ranges for ClotPro<sup>®</sup> in parturients were established by calculation of percentiles 2.5 and 97.5.</p> Results <p>Significant statistical differences in clot firmness were found across the EX-test, IN-test, and FIB-test (<i>p</i> &lt; 0.006) between parturient and non-pregnant participants. The most pronounced differences were observed in the FIB-test. Strong correlation was observed between conventional laboratory tests and FIB-test (Rs = 0.657, <i>p</i> &lt; 0.001 in the pregnant group; Rs = 0.669, <i>p</i> &lt; 0.001 in the control group). According to our findings, reference ranges were established for the parturient population: EX-test, CT (39–67&#xa0;s), A5 (39–59&#xa0;mm), ML (1–9%), MCF (57–70&#xa0;mm); FIB-test, A5 (15–29&#xa0;mm), MCF (19–35&#xa0;mm); and IN-test, CT (121–172&#xa0;s).</p> Conclusion <p>Pregnant women exhibit a distinct ClotPro<sup>®</sup> coagulation profile, characterised by increased clot firmness in FIB-test, supported by correlations with standard laboratory tests and parturient-specific reference intervals. These findings enhance the physiological interpretation of ClotPro<sup>®</sup> in obstetric care and may support its future integration into postpartum haemorrhage management.</p>

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ClotPro® haemostasis in pregnancy: physiological parameters, reference intervals and comparison with non-pregnant women in a prospective observational study

  • 期刊论文

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  • 发表日期：

    2026年3月13日

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  • Kamil Vrbica,
  • Jan Stingl,
  • Katerina Vanickova,
  • Ondrej Hrdy,
  • Radka Stepanova,
  • Petr Janku,
  • Lukas Hruban,
  • Roman Gal

摘要

Background

Severe haemorrhage remains a leading cause of maternal mortality worldwide, despite advancements in obstetric care. Although viscoelastic testing is recommended to guide treatment of postpartum haemorrhage, device-specific physiological parameters and reference ranges specific to pregnancy are necessary to enable accurate interpretation of viscoelastic findings in the clinical management of obstetric patients. Evaluation of ClotPro®, including comparison with conventional laboratory assays and with non-pregnant individuals, is therefore essential to support its use in obstetric patients.

Methods

In this prospective study, venous blood samples were obtained from 130 parturient participants before labour and 45 non-pregnant controls. Samples were analysed with conventional laboratory coagulation tests and the ClotPro® device. ClotPro® parameters and conventional laboratory tests were compared between the parturient population and non-pregnant control group with Student’s t-test or the Mann-Whitney U test, as appropriate. The correlation between selected laboratory and coagulation parameters was assessed with Spearman’s correlation coefficient. Reference ranges for ClotPro® in parturients were established by calculation of percentiles 2.5 and 97.5.

Results

Significant statistical differences in clot firmness were found across the EX-test, IN-test, and FIB-test (p < 0.006) between parturient and non-pregnant participants. The most pronounced differences were observed in the FIB-test. Strong correlation was observed between conventional laboratory tests and FIB-test (Rs = 0.657, p < 0.001 in the pregnant group; Rs = 0.669, p < 0.001 in the control group). According to our findings, reference ranges were established for the parturient population: EX-test, CT (39–67 s), A5 (39–59 mm), ML (1–9%), MCF (57–70 mm); FIB-test, A5 (15–29 mm), MCF (19–35 mm); and IN-test, CT (121–172 s).

Conclusion

Pregnant women exhibit a distinct ClotPro® coagulation profile, characterised by increased clot firmness in FIB-test, supported by correlations with standard laboratory tests and parturient-specific reference intervals. These findings enhance the physiological interpretation of ClotPro® in obstetric care and may support its future integration into postpartum haemorrhage management.