Pre-EclampsiaNCT05625763
State of Coagulation in Pre-eclampsia: Comparing Sonoclot Signature Analysis With Conventional and Specific Haemostasis Assays
An observational study of Pre-Eclampsia, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- sonoclot signature analysis
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2022to 29 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
- 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).
- Conditions
- Pre-Eclampsia
- Being tested
- sonoclot signature analysis
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonoclot signature analysisDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start15 Nov 2022 (estimated)
- Primary completion29 Nov 2024 (estimated)
- Study completion29 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, menna nashat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625763
- Sponsor's protocol ID
- koshy
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 32190981Osmanagaoglu 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 14735372Greer 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 25386350Simcox 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 26633369Alfirevic 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 11803092Philipp 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 24246297Saxena 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 24396346Min 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State of Coagulation in Pre-eclampsia: Comparing Sonoclot Signature Analysis With Conventional and Specific Haemostasis Assays
- ClinicalTrials.gov ID
- NCT05625763
- Acronym / sponsor ID
- koshy
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 29 Nov 2024 (estimated)
- Study completion
- 29 Dec 2024 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sonoclot signature analysisInvestigate 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. | Diagnostic test | – |
Primary outcome
sonoclot signature analysis in pre-eclampsia
Time frame: baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Background: PubMed 32190981Lalic-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.
- Background: PubMed 14735372Osmanagaoglu 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.
- Background: PubMed 25386350Greer 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.
- Background: PubMed 26633369Simcox 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.
- Background: PubMed 11803092Alfirevic 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.
- Background: PubMed 24246297Philipp 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.
- Background: PubMed 24396346Saxena 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.
- Background: PubMed 34707386Min 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mennatallah Nashat Abd El-Hafiz Ali, Master (01097009552, menna_nashat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sonoclot signature analysis in pre-eclampsia (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05625763, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.