evaluation of coagulation status of pregnant women in the peripartum period using the device clotpro®

Conditions: Coagulation and Hemorrhagic Disorders

Summary: the primary aim of the study is to determine the physiological parameters of the coagulation status of pregnant women in the peripartum period (pwpp) for the clotpro® device - ex-test (ct, cft, mcf, a5, a10, a20, ml), in-test (ct, cft, mcf, a5, a10, a20, ml) and fib-test (ct, cft, mcf, a5, a10, a20, ml) and based on these results, establish clotpro® reference ranges in parturients. the secondary aim is to compare the difference in coagulation parameters between pregnant women in the peripartum period and a control group of non-pregnant women (npw) on the clotpro® device. furthermore, a comparison with the physiological parameters of pregnant women in the peripartum period intended for rotem® and teg® devices (they are already known).

this is a prospective observational cross-sectional study with a control group whose task is to describe the physiological parameters of the coagulation status of pregnant women in the peripartum period measured on the clotpro® device. the study is monocentric and will take place at the brno university hospital. the study will evaluate a group of pregnant women in the peripartum period who come to give birth at the brno university hospital and fulfill the inclusion criteria, the target number is 120 patients. a control group of non-pregnant patients who fulfill the inclusion criteria to verify the difference between pregnant patients in the peripartum period and non-pregnant patients will also be included, the target number is 40 patients. for the participant the study is completed after obtaining the results from the clotpro® device, there will be no reaction to result. the study is an academic research project, not sponsored by a private entity, and data will not be provided to a private entity. the primary aim of the study is to determine the physiological parameters of the coagulation status of pregnant women in the peripartum period (pwpp) for the clotpro® device - ex-test (ct, cft, mcf, a5, a10, a20, ml), in-test (ct, cft, mcf, a5, a10, a20, ml) and fib-test (ct, cft, mcf, a5, a10, a20, ml) and based on these results, establish clotpro® reference ranges in parturients. the secondary aim is to compare the difference in coagulation parameters between pregnant women in the peripartum period and a control group of non-pregnant women (npw) on the clotpro® device. furthermore, a comparison with the physiological parameters of pregnant women in the peripartum period intended for rotem® and teg® devices (they are already known).

Eligibility criteria:
group: pregnant woman inclusion criteria: * age 18 - 45 years * bmi 18.5 - 30.0 * negative pregnancy test * the patient is able to sign an informed consent exclusion criteria: * antiplatelet treatment * anticoagulation treatment * hereditary or acquired coagulopathy * history of thrombosis or pulmonary embolism * acute or chronic inflammation (fever, septic condition, autoimmune disease) * active bleeding * history of hemato-oncological disease * refusal of inclusion in the study by the patient group: non-pregnant group inclusion criteria: * a pregnant woman admitted to department of gynecology and obstetrics for the labor at the physiological term (38th week (38+0) and more) * age 18 - 45 years * bmi 18.5 - 30.0 (before pregnancy) * blood samples are indicated for standard blood samples before labor * the patient is able to sign an informed consent at the time of admission exclusion criteria: * antiplatelet treatment * anticoagulation treatment * hereditary or acquired coagulopathy * history of thrombosis or pulmonary embolism * acute or chronic inflammation (fever, septic condition, autoimmune disease) * active bleeding * preeclampsia * eclampsia * gestational diabetes * abruption of the placenta * hellp syndrome * history of hemato-oncological disease * pregnancy in last 6 months * refusal of inclusion in the study by the patient

Keywords: blood coagulation fibrinogen viscoelastic method pregnancy labor