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Status unknownNCT05625763Updated Nov 23, 2022

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

An observational study in Pre-Eclampsia, sponsored by Assiut University. Status unknown. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-11-23.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
55
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.
Read the detailed 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).

02

Conditions studied

  • Pre-Eclampsia
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In context

Eclampsia

328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.

This study's planned enrollment of 55 is below the median of 158 across 146 observational studies indexed under Eclampsia.

Browse Eclampsia studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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.

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

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).
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
55 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testsonoclot 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.

06

What researchers measure

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.

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 32190981 ↗
  • 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. PubMed 14735372 ↗
  • 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. PubMed 25386350 ↗
  • 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. PubMed 26633369 ↗
  • 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. PubMed 11803092 ↗
  • 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. PubMed 24246297 ↗
  • 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. PubMed 24396346 ↗
  • 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. PubMed 34707386 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05625763
Lead sponsor
Assiut University
Responsible party
menna nashat (assiut- elgomhoriaa, Assiut University) — Principal investigator
First posted
Nov 23, 2022
Start date
Nov 15, 2022 (estimated)
Primary completion
Nov 29, 2024 (estimated)
Completion
Dec 29, 2024 (estimated)
Last update
Nov 23, 2022

Study contacts

Mennatallah Nashat Abd El-Hafiz Ali, Master
Contact
menna_nashat@yahoo.com
01097009552

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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