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

Ondrej Hrdy175 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

CT for Ex-test on ClotPro® device

Clotting time for Ex-test ClotPro® device

Time frame: before the labor

CT for In-test on ClotPro® device

Clotting time for In-test ClotPro® device

Time frame: before the labor

CT for Fib-test on ClotPro® device

Clotting time for Fib-test ClotPro® device

Time frame: before the labor

CFT for Ex-test on ClotPro® device

Clot formation time for Ex-test ClotPro® device

Time frame: before the labor

CFT for In-test on ClotPro® device

Clot formation time for In-test ClotPro® device

Time frame: before the labor

CFT for Fib-test on ClotPro® device

Clot formation time for Fib-test ClotPro® device

Time frame: before the labor

A5 for Ex-test on ClotPro® device

Maximum clot firmness in 5th minute for Ex-test ClotPro® device

Time frame: before the labor

A5 for In-test on ClotPro® device

Maximum clot firmness in 5th minute for In-test ClotPro® device

Time frame: before the labor

A5 for Fib-test on ClotPro® device

Maximum clot firmness in 5th minute for Fib-test ClotPro® device

Time frame: before the labor

A10 for Ex-test on ClotPro® device

Maximum clot firmness in 10th minute for Ex-test ClotPro® device

Time frame: before the labor

A10 for In-test on ClotPro® device

Maximum clot firmness in 10th minute for In-test ClotPro® device

Time frame: before the labor

A10 for Fib-test on ClotPro® device

Maximum clot firmness in 10th minute for Fib-test ClotPro® device

Time frame: before the labor

A20 for Ex-test on ClotPro® device

Maximum clot firmness in 20th minute for Ex-test ClotPro® device

Time frame: before the labor

A20 for In-test on ClotPro® device

Maximum clot firmness in 20th minute for In-test ClotPro® device

Time frame: before the labor

A20 for Fib-test on ClotPro® device

Maximum clot firmness in 20th minute for Fib-test ClotPro® device

Time frame: before the labor

MCF for Ex-test on ClotPro® device

Maximum clot firmness for Ex-test ClotPro® device

Time frame: before the labor

MCF for In-test on ClotPro® device

Maximum clot firmness for In-test ClotPro® device

Time frame: before the labor

MCF for Fib-test on ClotPro® device

Maximum clot firmness for Fib-test ClotPro® device

Time frame: before the labor

ML for Ex-test on ClotPro® device

Maximum lysis for Ex-test ClotPro® device

Time frame: before the labor

ML for In-test on ClotPro® device

Maximum lysis for In-test ClotPro® device

Time frame: before the labor

ML for Fib-test on ClotPro® device

Maximum lysis for Fib-test ClotPro® device

Time frame: before the labor

Hemoglobin level

Time frame: before the labor

Hematocrite level

Time frame: before the labor

Platelet level

Time frame: before the labor

Leucocytes level

Time frame: before the labor

Fibrinogen level

Time frame: before the labor

Prothrombin time

Time frame: before the labor

activated Partial thromboplastin time

Time frame: before the labor

INR

Time frame: before the labor

Thrombin time

Time frame: 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.

Time frame: before the labor

Secondary Outcomes

Age

Time frame: before the labor

Weight

Time frame: before the labor

Weight

Time frame: before pregnancy

Height

Time frame: before the labor

BMI

Time frame: before the labor

BMI

Time frame: before pregnancy

Number of pregnancies

Time frame: before the labor

Multiplicity of pregnancy

Time frame: before the labor

Smoking

Time frame: before the labor

Blood loss

Time frame: immediately after the labor

Type of labour

spontaneous labor or cesarian section

Time frame: immediately after the labor

Term of delivery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes