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

Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®, a Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05935137
Enrollment
175
Registered
2023-07-07
Start date
2023-05-26
Completion date
2024-01-17
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation and Hemorrhagic Disorders

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

DIAGNOSTIC_TESTCoagulation test on device ClotPro

The blood sample for coagulation test on device ClotPro will be take for both group and the test will be provided.

Sponsors

Ondrej Hrdy
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Establish ClotPro® reference ranges in parturientsbefore the laborReference 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® devicebefore the laborMaximum clot firmness for Fib-test ClotPro® device
ML for Ex-test on ClotPro® devicebefore the laborMaximum lysis for Ex-test ClotPro® device
ML for In-test on ClotPro® devicebefore the laborMaximum lysis for In-test ClotPro® device
ML for Fib-test on ClotPro® devicebefore the laborMaximum lysis for Fib-test ClotPro® device
Hemoglobin levelbefore the laborHemoglobin level
Hematocrite levelbefore the laborHematocrite level
Platelet levelbefore the laborPlatelet level
Leucocytes levelbefore the laborLeucocytes level
Fibrinogen levelbefore the laborFibrinogen level
Prothrombin timebefore the laborProthrombin time
activated Partial thromboplastin timebefore the laboractivated Partial thromboplastin time
INRbefore the laborINR
Thrombin timebefore the laborThrombin time
CT for Ex-test on ClotPro® devicebefore the laborClotting time for Ex-test ClotPro® device
CT for In-test on ClotPro® devicebefore the laborClotting time for In-test ClotPro® device
CT for Fib-test on ClotPro® devicebefore the laborClotting time for Fib-test ClotPro® device
CFT for Ex-test on ClotPro® devicebefore the laborClot formation time for Ex-test ClotPro® device
CFT for In-test on ClotPro® devicebefore the laborClot formation time for In-test ClotPro® device
CFT for Fib-test on ClotPro® devicebefore the laborClot formation time for Fib-test ClotPro® device
A5 for Ex-test on ClotPro® devicebefore the laborMaximum clot firmness in 5th minute for Ex-test ClotPro® device
A5 for In-test on ClotPro® devicebefore the laborMaximum clot firmness in 5th minute for In-test ClotPro® device
A5 for Fib-test on ClotPro® devicebefore the laborMaximum clot firmness in 5th minute for Fib-test ClotPro® device
A10 for Ex-test on ClotPro® devicebefore the laborMaximum clot firmness in 10th minute for Ex-test ClotPro® device
A10 for In-test on ClotPro® devicebefore the laborMaximum clot firmness in 10th minute for In-test ClotPro® device
A10 for Fib-test on ClotPro® devicebefore the laborMaximum clot firmness in 10th minute for Fib-test ClotPro® device
A20 for Ex-test on ClotPro® devicebefore the laborMaximum clot firmness in 20th minute for Ex-test ClotPro® device
A20 for In-test on ClotPro® devicebefore the laborMaximum clot firmness in 20th minute for In-test ClotPro® device
A20 for Fib-test on ClotPro® devicebefore the laborMaximum clot firmness in 20th minute for Fib-test ClotPro® device
MCF for Ex-test on ClotPro® devicebefore the laborMaximum clot firmness for Ex-test ClotPro® device
MCF for In-test on ClotPro® devicebefore the laborMaximum clot firmness for In-test ClotPro® device

Secondary

MeasureTime frameDescription
Weightbefore the laborWeight
Heightbefore the laborHeight
BMIbefore the laborBMI
Number of pregnanciesbefore the laborNumber of pregnancies
Multiplicity of pregnancybefore the laborMultiplicity of pregnancy
Smokingbefore the laborSmoking
Blood lossimmediately after the laborBlood loss
Type of labourimmediately after the laborspontaneous labor or cesarian section
Term of deliveryimmediately after the laborTerm of delivery
Comparison of fibrinogen level and Fib-testbefore the laborComparison of fibrinogen level and Fib-test
Comparison of Prothrombin time and CT in Ex-testbefore the laborCamparison of Prothrombin time and CT in Ex-test
Comparison of activated Partial thromboplastin time and In-testbefore the laborComparison of activated Partial thromboplastin time and In-test
Agebefore the laborAge

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026