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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-26

Study Completion Date

2024-01-17

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Coagulation and Hemorrhagic Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women

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.

Coagulation test on device ClotPro

Intervention Type DIAGNOSTIC_TEST

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

Non-pregnant women

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.

Coagulation test on device ClotPro

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Coagulation 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18 - 45 years
* BMI 18.5 - 30.0
* Negative pregnancy test
* The patient is able to sign an informed consent

* 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
* History of hemato-oncological disease
* Refusal of inclusion in the study by the patient

GROUP: Non-pregnant group

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes