Reference intervals for coagulation parameters in non-pregnant and pregnant women

Mengyu Fu,Kainan Dong,Jinfang Xing,Yanpeng Dai,Xuewei Zhang,Enwu Yuan,Yanzi Ding,Junjie Liu

doi:10.1038/s41598-022-05429-y

Mengyu Fu, Kainan Dong + Show 6 more

Open Access

https://doi.org/10.1038/s41598-022-05429-y

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Abstract

Established reference intervals (RIs) of coagulation parameters generally based on the general population are not applicable to specific women. In order to accurately evaluate the coagulation status of non-pregnant women and pregnant women, specific RIs should be established. Our study recruited 465 non-pregnant women and 1972 pregnant women aged 20–45 years. Eight tests including antithrombin (AT), protein C (PC), free protein S (fPS), lupus anticoagulant (LA), D-dimer, fibrin/fibrinogen degradation products (FDP), coagulation factor VII (FVII), and factor VIII (FVIII) were performed on ACL TOP automated coagulation instrument. The RIs for these tests were established in non-pregnant and pregnant women at different gestational weeks. Compared to the non-pregnant group, the medians of AT and fPS were lower, while the medians of PC, LA normalized ratio, D-dimer, FDP, FVII, and FVIII were higher. During pregnancy, AT and fPS activity showed a decreasing trend, with the increase of gestational age. PC activity, LA normalized ratio, D-dimer concentrations, FDP concentrations, FVII, and FVIII activity presented an increasing trend, with the increase of gestational age. The non-pregnant women-specific RIs and the gestational age-specific RIs of AT, PC, fPS, LA normalized ratio, D-dimer, FDP, FVII, and FVIII needed to be established for accurate clinical diagnoses.

Highlights

Established reference intervals (RIs) of coagulation parameters generally based on the general population are not applicable to specific women
The Kolmogorov–Smirnov test indicated that the distribution of the age, gestational age, AT, protein C (PC), free protein S (fPS), lupus anticoagulant (LA) normalized ratio, D-dimer, fibrinogen degradation products (FDP), factor VII (FVII), and factor VIII (FVIII) were not normally distributed
There have been some studies on the RIs of coagulation indexes, considering the influence of a variety of factors, each region should establish a local population-specific RIs

Summary

Introduction

Established reference intervals (RIs) of coagulation parameters generally based on the general population are not applicable to specific women. Compared to the non-pregnant group, the medians of AT and fPS were lower, while the medians of PC, LA normalized ratio, D-dimer, FDP, FVII, and FVIII were higher. The non-pregnant women-specific RIs and the gestational age-specific RIs of AT, PC, fPS, LA normalized ratio, D-dimer, FDP, FVII, and FVIII needed to be established for accurate clinical diagnoses. Most of the RIs for coagulation parameters used in clinical laboratories are derived from reagent manufacturers and are based on the general population. Whether these RIs apply to local non-pregnant and pregnant women has not been confirmed. Products (FDP), coagulation factor VII (FVII) and factor VIII (FVIII) according to CLSI guidelines for nonpregnant and pregnant women at different gestational weeks in Henan Province, China

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