Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®
- Conditions
- Coagulation and Hemorrhagic Disorders
- Interventions
- Diagnostic Test: Coagulation test on device ClotPro
- Registration Number
- NCT05935137
- Lead Sponsor
- Ondrej Hrdy
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 175
- Age 18 - 45 years
- BMI 18.5 - 30.0
- Negative pregnancy test
- The patient is able to sign an informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant women Coagulation test on device ClotPro 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 Coagulation test on device ClotPro 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.
- Primary Outcome Measures
Name Time Method 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
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
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
MCF for Fib-test on ClotPro® device before the labor Maximum clot firmness for Fib-test ClotPro® device
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.
- Secondary Outcome Measures
Name Time Method 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
Weight before pregnancy Weight
Height before the labor Height
BMI before pregnancy 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
Trial Locations
- Locations (1)
University Hospital Brno
🇨🇿Brno, Czechia