NCT05935137

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
• Phase: —
• Study type: Observational
• Enrollment: 175 (actual)
• Sponsor: Ondrej Hrdy · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Coagulation and Hemorrhagic Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2023-05-26
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2023-07-07
• Last updated: 2025-04-24

Locations

1 site across 1 country: Czechia