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

Ondrej Hrdy

Status: Completed

Conditions: Coagulation and Hemorrhagic Disorders

Treatments: Diagnostic Test: Coagulation test on device ClotPro

Study type: Observational

Funder types: Other

Identifiers

NCT05935137

01-120423/EK

Details and patient eligibility

About

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).

Full 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).

Enrollment: 175 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

175 participants in 2 patient groups

Pregnant women

Description:

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.

Treatment:

Diagnostic Test: Coagulation test on device ClotPro

Non-pregnant women

Description:

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.

Treatment:

Diagnostic Test: Coagulation test on device ClotPro