Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®

Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®, a Prospective Observational Study

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).

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