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

NCT05625763 | Unknown

• 1 other identifier: koshy
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

sonoclot signature analysis DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients with gestational age \< 20 weeks (First trimester).
• Patients in labour.
• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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.

  PMID: 32190981 BACKGROUND

• Osmanagaoglu MA, Topcuoglu K, Ozeren M, Bozkaya H. Coagulation inhibitors in preeclamptic pregnant women. Arch Gynecol Obstet. 2005 Mar;271(3):227-30. doi: 10.1007/s00404-003-0596-4. Epub 2004 Jan 21.

  PMID: 14735372 BACKGROUND

• 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.

  PMID: 25386350 BACKGROUND

• 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.

  PMID: 26633369 BACKGROUND

• 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. doi: 10.1016/s0301-2115(01)00496-1.

  PMID: 11803092 BACKGROUND

• 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.

  PMID: 24246297 BACKGROUND

• 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.

  PMID: 24396346 BACKGROUND

• 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.

  PMID: 34707386 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Mennatallah Nashat Abd El-Hafiz Ali, Master

CONTACT

01097009552; menna_nashat@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assiut- elgomhoriaa

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: November 15, 2022
• Primary Completion: November 29, 2024
• Study Completion: December 29, 2024
• Last Updated: November 23, 2022

Record last verified: 2022-11