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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) 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | 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. |
| |
| Non-pregnant women | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coagulation test on device ClotPro | Diagnostic Test | The blood sample for coagulation test on device ClotPro will be take for both group and the test will be provided. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age | before the labor |
| Weight | Weight | before the labor |
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GROUP: Pregnant woman
Inclusion Criteria:
Exclusion Criteria:
GROUP: Non-pregnant group
Inclusion Criteria:
Exclusion Criteria:
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GROUP: Pregnant woman Population of pregnant women fulfilling all inclusion criteria and none of exclusion criteria.
GROUP: Non-pregnant group Population of non-pregnant women fulfilling all inclusion criteria and none of exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Roman Gal, prof | Brno University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brno | Brno | 625 00 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25103301 | Result | Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5. | |
| 35297039 | Result | Escobar MF, Nassar AH, Theron G, Barnea ER, Nicholson W, Ramasauskaite D, Lloyd I, Chandraharan E, Miller S, Burke T, Ossanan G, Andres Carvajal J, Ramos I, Hincapie MA, Loaiza S, Nasner D; FIGO Safe Motherhood and Newborn Health Committee. FIGO recommendations on the management of postpartum hemorrhage 2022. Int J Gynaecol Obstet. 2022 Mar;157 Suppl 1(Suppl 1):3-50. doi: 10.1002/ijgo.14116. No abstract available. |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D006474 | Hemorrhagic Disorders |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006402 | Hematologic Diseases |
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| 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 |
| Establish ClotPro® reference ranges in parturients | Reference ranges will be established according to IFCC guidelines, based on physiological coagulation parameters measured in parturient women using the ClotPro® device. | 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 |
| 36855941 | Result | Kietaibl S, Ahmed A, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Godier A, Haas T, Jacob M, Lance MD, Llau JV, Meier J, Molnar Z, Mora L, Rahe-Meyer N, Samama CM, Scarlatescu E, Schlimp C, Wikkelso AJ, Zacharowski K. Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care: Second update 2022. Eur J Anaesthesiol. 2023 Apr 1;40(4):226-304. doi: 10.1097/EJA.0000000000001803. |
| 36859355 | Result | Rossaint R, Afshari A, Bouillon B, Cerny V, Cimpoesu D, Curry N, Duranteau J, Filipescu D, Grottke O, Gronlykke L, Harrois A, Hunt BJ, Kaserer A, Komadina R, Madsen MH, Maegele M, Mora L, Riddez L, Romero CS, Samama CM, Vincent JL, Wiberg S, Spahn DR. The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition. Crit Care. 2023 Mar 1;27(1):80. doi: 10.1186/s13054-023-04327-7. |
| 24486836 | Result | de Lange NM, van Rheenen-Flach LE, Lance MD, Mooyman L, Woiski M, van Pampus EC, Porath M, Bolte AC, Smits L, Henskens YM, Scheepers HC. Peri-partum reference ranges for ROTEM(R) thromboelastometry. Br J Anaesth. 2014 May;112(5):852-9. doi: 10.1093/bja/aet480. Epub 2014 Jan 31. |
| D006425 |
| Hemic and Lymphatic Diseases |