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

Study Overview
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Brief Summary
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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). 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), as well as the dependence of the parameters on the number of pregnancies, multiple pregnancies and smoking.

Detailed Description
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This is a prospective observational 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). 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), as well as the dependence of the parameters on the number of pregnancies, multiple pregnancies and smoking.

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

Conditions
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Coagulation and Hemorrhagic Disorders

Intervention / Treatment
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* Diagnostic Test: Coagulation test on device ClotPro


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>It is a group of pregnant women after finished 37th week of gestation. We will take blood sample for a coagulation test on the device ClotPro.There is no more intervention. | Diagnostic Test: Coagulation test on device ClotPro<br>* The blood sample for coagulation test on device ClotPro will be take for both group and the test will be provided.<br>|
| Non-pregnant women<br>It is a control group - non-pregnant women. We will take blood samples for blood count and coagulation status and a coagulation test on the device ClotPro.There is no more intervention. | Diagnostic Test: Coagulation test on device ClotPro<br>* The blood sample for coagulation test on device ClotPro will be take for both group and the test will be provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT for Ex-test on ClotPro® device | Clotting time for Ex-test ClotPro® device | before the labor | 
| CT for In-test on ClotPro® device | Clotting time for In-test ClotPro® device | before the labor | 
| CT for Fib-test on ClotPro® device | Clotting time for Fib-test ClotPro® device | before the labor | 
| CFT for Ex-test on ClotPro® device | Clot formation time for Ex-test ClotPro® device | before the labor | 
| CFT for In-test on ClotPro® device | Clot formation time for In-test ClotPro® device | before the labor | 
| CFT for Fib-test on ClotPro® device | Clot formation time for Fib-test ClotPro® device | before the labor | 
| A5 for Ex-test on ClotPro® device | Maximum clot firmness in 5th minute for Ex-test ClotPro® device | before the labor | 
| A5 for In-test on ClotPro® device | Maximum clot firmness in 5th minute for In-test ClotPro® device | before the labor | 
| A5 for Fib-test on ClotPro® device | Maximum clot firmness in 5th minute for Fib-test ClotPro® device | before the labor | 
| A10 for Ex-test on ClotPro® device | Maximum clot firmness in 10th minute for Ex-test ClotPro® device | before the labor | 
| A10 for In-test on ClotPro® device | Maximum clot firmness in 10th minute for In-test ClotPro® device | before the labor | 
| A10 for Fib-test on ClotPro® device | Maximum clot firmness in 10th minute for Fib-test ClotPro® device | before the labor | 
| A20 for Ex-test on ClotPro® device | Maximum clot firmness in 20th minute for Ex-test ClotPro® device | before the labor | 
| A20 for In-test on ClotPro® device | Maximum clot firmness in 20th minute for In-test ClotPro® device | before the labor | 
| A20 for Fib-test on ClotPro® device | Maximum clot firmness in 20th minute for Fib-test ClotPro® device | before the labor | 
| MCF for Ex-test on ClotPro® device | Maximum clot firmness for Ex-test ClotPro® device | before the labor | 
| MCF for In-test on ClotPro® device | Maximum clot firmness for In-test ClotPro® device | before the labor | 
| MCF for Fib-test on ClotPro® device | Maximum clot firmness for Fib-test ClotPro® device | before the labor | 
| ML for Ex-test on ClotPro® device | Maximum lysis for Ex-test ClotPro® device | before the labor | 
| ML for In-test on ClotPro® device | Maximum lysis for In-test ClotPro® device | before the labor | 
| ML for Fib-test on ClotPro® device | Maximum lysis for Fib-test ClotPro® device | before the labor | 
| Hemoglobin level | Hemoglobin level | before the labor | 
| Hematocrite level | Hematocrite level | before the labor | 
| Platelet level | Platelet level | before the labor | 
| Leucocytes level | Leucocytes level | before the labor | 
| Fibrinogen level | Fibrinogen level | before the labor | 
| Prothrombin time | Prothrombin time | before the labor | 
| activated Partial thromboplastin time | activated Partial thromboplastin time | before the labor | 
| INR | INR | before the labor | 
| Thrombin time | Thrombin time | before the labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age | before the labor | 
| Weight | Weight | before the labor | 
| Weight | Weight | before pregnancy | 
| Height | Height | before the labor | 
| BMI | BMI | before the labor | 
| BMI | BMI | before pregnancy | 
| Number of pregnancies | Number of pregnancies | before the labor | 
| Multiplicity of pregnancy | Multiplicity of pregnancy | before the labor | 
| Smoking | Smoking | before the labor | 
| Blood loss | Blood loss | immediately after the labor | 
| Type of labour | spontaneous labor or cesarian section | immediately after the labor | 
| Term of delivery | Term of delivery | immediately after the labor | 
| Comparison of fibrinogen level and Fib-test | Comparison of fibrinogen level and Fib-test | before the labor | 
| Comparison of Prothrombin time and CT in Ex-test | Camparison of Prothrombin time and CT in Ex-test | before the labor | 
| Comparison of activated Partial thromboplastin time and In-test | Comparison of activated Partial thromboplastin time and In-test | before the labor | 
| Comparison of BMI with Fib-test | Comparison of BMI with Fib-test | before the labor | 
| Comparison of BMI with Ex-test | Comparison of BMI with Ex-test | before the labor | 
| comparison of blood loss and Fib-test | determining the dependence between blood loss and Fib-test | immediately after the labor | 
| comparison of blood loss and Ex-test | determining the dependence between blood loss and Ex-test | immediately after the labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood coagulation, Fibrinogen, Viscoelastic method, Pregnancy, Labor