Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®, a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Leucocytes level
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 45 years
- •BMI 18.5 - 30.0
- •Negative pregnancy test
- •The patient is able to sign an informed consent
排除标准
- •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
结局指标
主要结局
Leucocytes level
时间窗: before the labor
Leucocytes level
CT for Ex-test on ClotPro® device
时间窗: before the labor
Clotting time for Ex-test ClotPro® device
CT for In-test on ClotPro® device
时间窗: before the labor
Clotting time for In-test ClotPro® device
CT for Fib-test on ClotPro® device
时间窗: before the labor
Clotting time for Fib-test ClotPro® device
CFT for Ex-test on ClotPro® device
时间窗: before the labor
Clot formation time for Ex-test ClotPro® device
CFT for In-test on ClotPro® device
时间窗: before the labor
Clot formation time for In-test ClotPro® device
ML for Ex-test on ClotPro® device
时间窗: before the labor
Maximum lysis for Ex-test ClotPro® device
ML for In-test on ClotPro® device
时间窗: before the labor
Maximum lysis for In-test ClotPro® device
ML for Fib-test on ClotPro® device
时间窗: before the labor
Maximum lysis for Fib-test ClotPro® device
Hemoglobin level
时间窗: before the labor
Hemoglobin level
Hematocrite level
时间窗: before the labor
Hematocrite level
Platelet level
时间窗: before the labor
Platelet level
Fibrinogen level
时间窗: before the labor
Fibrinogen level
Prothrombin time
时间窗: before the labor
Prothrombin time
activated Partial thromboplastin time
时间窗: before the labor
activated Partial thromboplastin time
INR
时间窗: before the labor
INR
Thrombin time
时间窗: before the labor
Thrombin time
CFT for Fib-test on ClotPro® device
时间窗: before the labor
Clot formation time for Fib-test ClotPro® device
A5 for Ex-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness in 5th minute for Ex-test ClotPro® device
A5 for In-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness in 5th minute for In-test ClotPro® device
A5 for Fib-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness in 5th minute for Fib-test ClotPro® device
A10 for Ex-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness in 10th minute for Ex-test ClotPro® device
A10 for In-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness in 10th minute for In-test ClotPro® device
A10 for Fib-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness in 10th minute for Fib-test ClotPro® device
A20 for Ex-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness in 20th minute for Ex-test ClotPro® device
A20 for In-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness in 20th minute for In-test ClotPro® device
A20 for Fib-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness in 20th minute for Fib-test ClotPro® device
MCF for Ex-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness for Ex-test ClotPro® device
MCF for In-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness for In-test ClotPro® device
MCF for Fib-test on ClotPro® device
时间窗: before the labor
Maximum clot firmness for Fib-test ClotPro® device
Establish ClotPro® reference ranges in parturients
时间窗: 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.
次要结局
- Comparison of fibrinogen level and Fib-test(before the labor)
- Comparison of Prothrombin time and CT in Ex-test(before the labor)
- Comparison of activated Partial thromboplastin time and In-test(before the labor)
- Age(before the labor)
- Weight(before pregnancy)
- Height(before the labor)
- BMI(before pregnancy)
- Number of pregnancies(before the labor)
- Multiplicity of pregnancy(before the labor)
- Smoking(before the labor)
- Blood loss(immediately after the labor)
- Type of labour(immediately after the labor)
- Term of delivery(immediately after the labor)
研究者
Ondrej Hrdy
vice chair for education
Brno University Hospital