REFERENCE INTERVALS FOR HEMOSTASIOLOGICAL LABORATORY TESTS DURING PHYSIOLOGICAL PREGNANCY


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Abstract

Objective. To generate reference intervals for hemostasiological tests in relation to the period of physiological pregnancy. Subjects and methods. A total of828 women with uncomplicated singleton pregnancy were examined. The patients were divided into 6 subgroups in accordance with the gestational age (4-8, 9-13, 14-20, 21-27, 28-34, and 35-40 weeks). Eight most common hemostasiological laboratory tests, such as prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), the activity of antithrombin III (ATIII) and protein C, and the concentration of fibrinogen, D-dimer, and von Willebrand factor (vWF), were investigated. 2.5th and 97.5th percentile values were calculated for these indicators according to the International Federation of Clinical Chemistry (IFCC) guidelines for the statistical processing of references values. Results. Reference intervals were obtained for PT, APTT, TT, fibrinogen, vWF, D-dimer, ATIII, and protein C in these periods of pregnancy. There were changes in most tests as compared to those obtained in a control group of nonpregnant women (p < 0.05). Conclusion. Special reference intervals must be used to assess the results of coagulation tests in pregnant women. The findings may be employed in other clinical and diagnostic laboratories after appropriate validation in accordance with the requirements of the Clinical and Laboratory Standards Institute (CLSI).

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About the authors

Tatiana Y. Ivanets

Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia

Email: t_ivanets@oparina4.ru
PhD., Head of the Scientific Diagnostical Laboratory Moscow 117997, Ac. Oparina str. 4, Russia

Mariya A. Vinogradova

Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia

Email: m_vinogradova@oparina4.ru
PhD., Head of Reproductive Hematology and Clinical Hemostasiology Department Moscow 117997, Ac. Oparina str. 4, Russia

Nataliya Vitalievna Dolgushina

Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia

Email: n_dolgushina@oparina4.ru
M.D., Ph.D., M.P.H., Head of R&D Department Moscow 117997, Ac. Oparina str. 4, Russia

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