Clinical trial NCT05935137: Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®
Official title: Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®, a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation and Hemorrhagic Disorders
Keywords: Blood coagulation
Fibrinogen
Viscoelastic method
Pregnancy
Labor
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

Eligibility 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

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

Primary outcomes:
measure: CT for Ex-test on ClotPro® device
timeFrame: before the labor
measure: CT for In-test on ClotPro® device
timeFrame: before the labor
measure: CT for Fib-test on ClotPro® device
timeFrame: before the labor
measure: CFT for Ex-test on ClotPro® device
timeFrame: before the labor
measure: CFT for In-test on ClotPro® device
timeFrame: before the labor
measure: CFT for Fib-test on ClotPro® device
timeFrame: before the labor
measure: A5 for Ex-test on ClotPro® device
timeFrame: before the labor
measure: A5 for In-test on ClotPro® device
timeFrame: before the labor
measure: A5 for Fib-test on ClotPro® device
timeFrame: before the labor
measure: A10 for Ex-test on ClotPro® device
timeFrame: before the labor
measure: A10 for In-test on ClotPro® device
timeFrame: before the labor
measure: A10 for Fib-test on ClotPro® device
timeFrame: before the labor
measure: A20 for Ex-test on ClotPro® device
timeFrame: before the labor
measure: A20 for In-test on ClotPro® device
timeFrame: before the labor
measure: A20 for Fib-test on ClotPro® device
timeFrame: before the labor
measure: MCF for Ex-test on ClotPro® device
timeFrame: before the labor
measure: MCF for In-test on ClotPro® device
timeFrame: before the labor
measure: MCF for Fib-test on ClotPro® device
timeFrame: before the labor
measure: ML for Ex-test on ClotPro® device
timeFrame: before the labor
measure: ML for In-test on ClotPro® device
timeFrame: before the labor
measure: ML for Fib-test on ClotPro® device
timeFrame: before the labor
measure: Hemoglobin level
timeFrame: before the labor
measure: Hematocrite level
timeFrame: before the labor
measure: Platelet level
timeFrame: before the labor
measure: Leucocytes level
timeFrame: before the labor
measure: Fibrinogen level
timeFrame: before the labor
measure: Prothrombin time
timeFrame: before the labor
measure: activated Partial thromboplastin time
timeFrame: before the labor
measure: INR
timeFrame: before the labor
measure: Thrombin time
timeFrame: before the labor
measure: Establish ClotPro® reference ranges in parturients
timeFrame: before the labor
Secondary outcomes:
measure: Age
timeFrame: before the labor
measure: Weight
timeFrame: before the labor
measure: Weight
timeFrame: before pregnancy
measure: Height
timeFrame: before the labor
measure: BMI
timeFrame: before the labor
measure: BMI
timeFrame: before pregnancy
measure: Number of pregnancies
timeFrame: before the labor
measure: Multiplicity of pregnancy
timeFrame: before the labor
measure: Smoking
timeFrame: before the labor
measure: Blood loss
timeFrame: immediately after the labor
measure: Type of labour
timeFrame: immediately after the labor
measure: Term of delivery
timeFrame: immediately after the labor
measure: Comparison of fibrinogen level and Fib-test
timeFrame: before the labor
measure: Comparison of Prothrombin time and CT in Ex-test
timeFrame: before the labor
measure: Comparison of activated Partial thromboplastin time and In-test
timeFrame: before the labor
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: University Hospital Brno
name: Roman Gal, prof
role: STUDY_DIRECTOR
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