Coagulation and Hemorrhagic Disorders
Conditions
Keywords
Blood coagulation, Fibrinogen, Viscoelastic method, Pregnancy, Labor
Brief 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).
Detailed description
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).
Interventions
The blood sample for coagulation test on device ClotPro will be take for both group and the test will be provided.
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish ClotPro® reference ranges in parturients | before the labor | Reference ranges will be established according to IFCC guidelines, based on physiological coagulation parameters measured in parturient women using the ClotPro® device. |
| MCF for Fib-test on ClotPro® device | before the labor | Maximum clot firmness for Fib-test ClotPro® device |
| ML for Ex-test on ClotPro® device | before the labor | Maximum lysis for Ex-test ClotPro® device |
| ML for In-test on ClotPro® device | before the labor | Maximum lysis for In-test ClotPro® device |
| ML for Fib-test on ClotPro® device | before the labor | Maximum lysis for Fib-test ClotPro® device |
| Hemoglobin level | before the labor | Hemoglobin level |
| Hematocrite level | before the labor | Hematocrite level |
| Platelet level | before the labor | Platelet level |
| Leucocytes level | before the labor | Leucocytes level |
| Fibrinogen level | before the labor | Fibrinogen level |
| Prothrombin time | before the labor | Prothrombin time |
| activated Partial thromboplastin time | before the labor | activated Partial thromboplastin time |
| INR | before the labor | INR |
| Thrombin time | before the labor | Thrombin time |
| CT for Ex-test on ClotPro® device | before the labor | Clotting time for Ex-test ClotPro® device |
| CT for In-test on ClotPro® device | before the labor | Clotting time for In-test ClotPro® device |
| CT for Fib-test on ClotPro® device | before the labor | Clotting time for Fib-test ClotPro® device |
| CFT for Ex-test on ClotPro® device | before the labor | Clot formation time for Ex-test ClotPro® device |
| CFT for In-test on ClotPro® device | before the labor | Clot formation time for In-test ClotPro® device |
| CFT for Fib-test on ClotPro® device | before the labor | Clot formation time for Fib-test ClotPro® device |
| A5 for Ex-test on ClotPro® device | before the labor | Maximum clot firmness in 5th minute for Ex-test ClotPro® device |
| A5 for In-test on ClotPro® device | before the labor | Maximum clot firmness in 5th minute for In-test ClotPro® device |
| A5 for Fib-test on ClotPro® device | before the labor | Maximum clot firmness in 5th minute for Fib-test ClotPro® device |
| A10 for Ex-test on ClotPro® device | before the labor | Maximum clot firmness in 10th minute for Ex-test ClotPro® device |
| A10 for In-test on ClotPro® device | before the labor | Maximum clot firmness in 10th minute for In-test ClotPro® device |
| A10 for Fib-test on ClotPro® device | before the labor | Maximum clot firmness in 10th minute for Fib-test ClotPro® device |
| A20 for Ex-test on ClotPro® device | before the labor | Maximum clot firmness in 20th minute for Ex-test ClotPro® device |
| A20 for In-test on ClotPro® device | before the labor | Maximum clot firmness in 20th minute for In-test ClotPro® device |
| A20 for Fib-test on ClotPro® device | before the labor | Maximum clot firmness in 20th minute for Fib-test ClotPro® device |
| MCF for Ex-test on ClotPro® device | before the labor | Maximum clot firmness for Ex-test ClotPro® device |
| MCF for In-test on ClotPro® device | before the labor | Maximum clot firmness for In-test ClotPro® device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | before the labor | Weight |
| Height | before the labor | Height |
| BMI | before the labor | BMI |
| Number of pregnancies | before the labor | Number of pregnancies |
| Multiplicity of pregnancy | before the labor | Multiplicity of pregnancy |
| Smoking | before the labor | Smoking |
| Blood loss | immediately after the labor | Blood loss |
| Type of labour | immediately after the labor | spontaneous labor or cesarian section |
| Term of delivery | immediately after the labor | Term of delivery |
| Comparison of fibrinogen level and Fib-test | before the labor | Comparison of fibrinogen level and Fib-test |
| Comparison of Prothrombin time and CT in Ex-test | before the labor | Camparison of Prothrombin time and CT in Ex-test |
| Comparison of activated Partial thromboplastin time and In-test | before the labor | Comparison of activated Partial thromboplastin time and In-test |
| Age | before the labor | Age |
Countries
Czechia