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

NCT05935137 | Completed

• 1 other identifier: 01-120423/EK
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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).

Conditions

Coagulation and Hemorrhagic Disorders

Keywords

Blood coagulation; Fibrinogen; Viscoelastic method; Pregnancy; Labor

Outcome Measures

Primary Outcomes (31)

• CT for Ex-test on ClotPro® device

  Clotting time for Ex-test ClotPro® device

  before the labor

• CT for In-test on ClotPro® device

  Clotting time for In-test ClotPro® device

  before the labor

• CT for Fib-test on ClotPro® device

  Clotting time for Fib-test ClotPro® device

  before the labor

• CFT for Ex-test on ClotPro® device

  Clot formation time for Ex-test ClotPro® device

  before the labor

• CFT for In-test on ClotPro® device

  Clot formation time for In-test ClotPro® device

  before the labor

• CFT for Fib-test on ClotPro® device

  Clot formation time for Fib-test ClotPro® device

  before the labor

• A5 for Ex-test on ClotPro® device

  Maximum clot firmness in 5th minute for Ex-test ClotPro® device

  before the labor

• A5 for In-test on ClotPro® device

  Maximum clot firmness in 5th minute for In-test ClotPro® device

  before the labor

• A5 for Fib-test on ClotPro® device

  Maximum clot firmness in 5th minute for Fib-test ClotPro® device

  before the labor

• A10 for Ex-test on ClotPro® device

  Maximum clot firmness in 10th minute for Ex-test ClotPro® device

  before the labor

• A10 for In-test on ClotPro® device

  Maximum clot firmness in 10th minute for In-test ClotPro® device

  before the labor

• A10 for Fib-test on ClotPro® device

  Maximum clot firmness in 10th minute for Fib-test ClotPro® device

  before the labor

• A20 for Ex-test on ClotPro® device

  Maximum clot firmness in 20th minute for Ex-test ClotPro® device

  before the labor

• A20 for In-test on ClotPro® device

  Maximum clot firmness in 20th minute for In-test ClotPro® device

  before the labor

• A20 for Fib-test on ClotPro® device

  Maximum clot firmness in 20th minute for Fib-test ClotPro® device

  before the labor

• MCF for Ex-test on ClotPro® device

  Maximum clot firmness for Ex-test ClotPro® device

  before the labor

• MCF for In-test on ClotPro® device

  Maximum clot firmness for In-test ClotPro® device

  before the labor

• MCF for Fib-test on ClotPro® device

  Maximum clot firmness for Fib-test ClotPro® device

  before the labor

• ML for Ex-test on ClotPro® device

  Maximum lysis for Ex-test ClotPro® device

  before the labor

• ML for In-test on ClotPro® device

  Maximum lysis for In-test ClotPro® device

  before the labor

• ML for Fib-test on ClotPro® device

  Maximum lysis for Fib-test ClotPro® device

  before the labor

• Hemoglobin level

  Hemoglobin level

  before the labor

• Hematocrite level

  Hematocrite level

  before the labor

• Platelet level

  Platelet level

  before the labor

• Leucocytes level

  Leucocytes level

  before the labor

• Fibrinogen level

  Fibrinogen level

  before the labor

• Prothrombin time

  Prothrombin time

  before the labor

• activated Partial thromboplastin time

  activated Partial thromboplastin time

  before the labor

• INR

  INR

  before the labor

• Thrombin time

  Thrombin time

  before the labor

• Establish ClotPro® reference ranges in parturients

  Reference ranges will be established according to IFCC guidelines, based on physiological coagulation parameters measured in parturient women using the ClotPro® device.

  before the labor

Secondary Outcomes (15)

• Age

  before the labor

• Weight

  before the labor

• Weight

  before pregnancy

• Height

  before the labor

• BMI

  before the labor

Study Arms (2)

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.

Diagnostic Test: Coagulation test on device ClotPro

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.

Diagnostic Test: Coagulation test on device ClotPro

Interventions

Coagulation test on device ClotPro 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; Pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• GROUP: Non-pregnant group
• 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
• Antiplatelet treatment
• Anticoagulation treatment

Sponsors & Collaborators

• Ondrej Hrdy: lead

Study Sites (1)

University Hospital Brno

Brno, 625 00, Czechia

Location

Related Publications (5)

• Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

  PMID: 25103301 BACKGROUND

• Ohno N, Fukamiya N, Okano M, Tagahara K, Lee KH. Synthesis of cytotoxic fluorinated quassinoids. Bioorg Med Chem. 1997 Aug;5(8):1489-95. doi: 10.1016/s0968-0896(97)00095-3.

  PMID: 9313855 BACKGROUND

• Kietaibl S, Ahmed A, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Godier A, Haas T, Jacob M, Lance MD, Llau JV, Meier J, Molnar Z, Mora L, Rahe-Meyer N, Samama CM, Scarlatescu E, Schlimp C, Wikkelso AJ, Zacharowski K. Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care: Second update 2022. Eur J Anaesthesiol. 2023 Apr 1;40(4):226-304. doi: 10.1097/EJA.0000000000001803.

  PMID: 36855941 BACKGROUND

• Quinlan SM, Scalapino DJ. Neutron scattering from a dx2-y2-wave superconductor with strong impurity scattering and Coulomb correlations. Phys Rev B Condens Matter. 1995 Jan 1;51(1):497-504. doi: 10.1103/physrevb.51.497. No abstract available.

  PMID: 9977110 BACKGROUND

• de Lange NM, van Rheenen-Flach LE, Lance MD, Mooyman L, Woiski M, van Pampus EC, Porath M, Bolte AC, Smits L, Henskens YM, Scheepers HC. Peri-partum reference ranges for ROTEM(R) thromboelastometry. Br J Anaesth. 2014 May;112(5):852-9. doi: 10.1093/bja/aet480. Epub 2014 Jan 31.

  PMID: 24486836 BACKGROUND

MeSH Terms

Conditions

Thrombosis; Hemorrhagic Disorders

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Roman Gal, prof

  University Hospital Brno

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: vice chair for education

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 7, 2023
• Study Start: May 26, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)