State of Coagulation in Pre-eclampsia: Comparing Sonoclot Signature Analysis With Conventional and Specific Haemostasis Assays

Pre-Eclampsia Clinical Trial

Official title:

State of Coagulation in Pre-eclampsia: Comparing Sonoclot Signature Analysis With Conventional and Specific Haemostasis Assays

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05625763
• Other study ID #: koshy
• Status: Not yet recruiting
• Start date: November 15, 2022
• Est. completion date: December 29, 2024

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: Mennatallah Nashat Abd El-Hafiz Ali, Master
• Phone: 01097009552
• Email: menna_nashat[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• Detection of the presence or absence of coagulopathy in cases with pre-eclampsia.

• Investigate the value of global hemostasis studies (Sonoclot signature analysis) in cases of pre-eclampsia and if there a correlation between it and the specific traditional assays of hemostasis.

Description:

Pre-eclampsia remains a major cause of morbidity and mortality in pregnant women, as well in their newborns (1). Despite intense study, preeclampsia remains poorly understood and a major cause of maternal and foetal morbidity and mortality. It's clear that vascular endothelial dysfunction, which may lead to hypertension by imbalance between vasoactive, and vasodilator agents, is an important component of this disorder. The induction of endothelial dysfunction is probably multifactorial (2). Some researchers suggested that hereditary and acquired thrombophilia has been associated with recurrent pregnancy loss and gestational vascular complications, such as early-onset pre-eclampsia and placental abruption (3). Despite it is widely known that pregnancy induces a state of hypercoagulability (4), publications failed to demonstrate a uniform pattern of pathology that can carry the association between thrombophilia and adverse pregnancy outcomes, as between factor V Leiden mutation, MTHFR C677T mutation, G20210A Prothrombin gene mutation, Anti-thrombin III deficiency, Protein C,S deficiency and other causes of thrombophilia, different researchers claimed different causes of the previously mentioned as the one responsible for maternal thrombophilia (2, 3, 5). Others claimed racial variations were associated with the state of thrombophilia (6).

Other than standard routine and specific tests, various other methods are used to record coagulation profile. One of them is estimation by sonoclot, which is a viscoelastic hemostatic assays device (7). Sonoclot have practical advantages as point-of-care device for monitoring major hemorrhage including a set of parameters that assesses a global coagulation profile and can indicate the presence of hypercoagulable state (8). Establishing correlations between Sonoclot parameters and conventional hemostasis assays could open a path of better monitoring of patients with suspected coagulopathies, and can be helpful in guiding management of preeclampsia and preventing severe maternal outcomes (7).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: December 29, 2024
• Est. primary completion date: November 29, 2024
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Pregnant pre-eclamptic patients with blood pressure > 140/90 mm hg and proteinuria > 0.39/24 hrs., with gestational age between 20-42 weeks (second & third trimester).

2. Pregnant normotensive females with no pregnancy complications and gestational age 20-42 weeks to act as controls.

Exclusion Criteria:

1. Patients with gestational age < 20 weeks (First trimester).

2. Patients in labour.

3. Patients with foetal malformations, history of chronic hypertension, diabetes mellitus, renal diseases, collagen vascular disease, anaemia, cardiovascular diseases and patients known to be thrombophilic before pregnancy (acquired or inherited).

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Diagnostic Test:
• sonoclot signature analysis
Investigate the value of global hemostasis studies (Sonoclot signature analysis) in cases of pre-eclampsia and if there a correlation between it and the specific traditional assays of hemostasis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Alfirevic Z, Roberts D, Martlew V. How strong is the association between maternal thrombophilia and adverse pregnancy outcome? A systematic review. Eur J Obstet Gynecol Reprod Biol. 2002 Feb 10;101(1):6-14. Review. — View Citation

Greer IA, Aharon A, Brenner B, Gris JC. Coagulation and placenta-mediated complications. Rambam Maimonides Med J. 2014 Oct 29;5(4):e0034. doi: 10.5041/RMMJ.10168. eCollection 2014 Oct. — View Citation

Lalic-Cosic S, Dopsaj V, Kovac M, Pruner I, Littmann K, Mandic-Markovic V, Mikovic Z, Antovic A. Evaluation of global haemostatic assays and fibrin structure in patients with pre-eclampsia. Int J Lab Hematol. 2020 Jun;42(3):322-330. doi: 10.1111/ijlh.13183. Epub 2020 Mar 19. — View Citation

Min J, Wan P, Liu G, Yu M, Su L. Sonoclot Signature Analysis: A New Point-of-Care Testing Method for Defining Heat Stroke-Induced Coagulopathy. Int J Gen Med. 2021 Oct 20;14:6925-6933. doi: 10.2147/IJGM.S321982. eCollection 2021. — View Citation

Osmanagaoglu MA, Topçuoglu K, Ozeren M, Bozkaya H. Coagulation inhibitors in preeclamptic pregnant women. Arch Gynecol Obstet. 2005 Mar;271(3):227-30. Epub 2004 Jan 21. — View Citation

Philipp CS, Faiz AS, Beckman MG, Grant A, Bockenstedt PL, Heit JA, James AH, Kulkarni R, Manco-Johnson MJ, Moll S, Ortel TL. Differences in thrombotic risk factors in black and white women with adverse pregnancy outcome. Thromb Res. 2014 Jan;133(1):108-11. doi: 10.1016/j.thromres.2013.10.035. Epub 2013 Nov 1. — View Citation

Saxena P, Bihari C, Rastogi A, Agarwal S, Anand L, Sarin SK. Sonoclot signature analysis in patients with liver disease and its correlation with conventional coagulation studies. Adv Hematol. 2013;2013:237351. doi: 10.1155/2013/237351. Epub 2013 Dec 11. — View Citation

Simcox LE, Ormesher L, Tower C, Greer IA. Thrombophilia and Pregnancy Complications. Int J Mol Sci. 2015 Nov 30;16(12):28418-28. doi: 10.3390/ijms161226104. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sonoclot signature analysis in pre-eclampsia	Investigate the value of global hemostasis studies (Sonoclot signature analysis) in cases of pre-eclampsia and if there a correlation between it and the specific traditional assays of hemostasis.	baseline